Losartan therapy in adults with Marfan syndrome: study protocol of the multi-center randomized controlled COMPARE trial

Background Marfan syndrome (MFS) is one of the most common systemic disorders of connective tissue with the incidence of approximately 2-3 per 10 000 individuals. Aortic disease, leading to progressive aneurysmal dilatation and dissection is the main cause of morbidity and mortality of Marfan patients. Current treatment (e.g. beta blockers and elective surgery) does postpone but cannot prevent aortic complications in these patients. Recent studies have found Transforming Growth Factor β (TGF β) to be involved in the aortic aneurysm formation. Losartan, an Angiotensin II type 1 receptor blocker inhibits TGFβ in a mouse model of Marfan syndrome leading to inhibition of aortic growth. The main objective of this trial is to assess whether losartan treatment leads to a clinically relevant decrease of aortic dilatation in adult patients with Marfan syndrome. Methods/Design COMPARE study (COzaar in Marfan Patients Reduces aortic Enlargement) is an open-label, randomized, controlled trial with blinded end-points. Treatment with losartan will be compared with no additional treatment after 3 years of follow-up. We will enroll 330 patients with MFS who will be randomly assigned to receive losartan or not. Patients taking beta-blockers will continue taking their standard treatment. The primary end-point is the largest change in aortic diameter at any aortic level measured by means of MRI. Secondary end-points are change in mortality, incidence of dissection, elective aortic surgery, aortic volume, aortic stiffness and ventricular function. We will also investigate gene and protein expression change in the skin under losartan therapy and create prediction models for losartan-treatment response and aortic dilatation. Discussion The COMPARE study will provide important evidence of effects of losartan treatment in adult Marfan patient population. We expect losartan to significantly reduce the occurrence and progression of aortic dilatation. This trial investigates a wide spectrum of clinical, genetic and biochemical effects of losartan aiming to provide further insight in the pathogenesis and treatment of Marfan syndrome. Trial registration Netherlands Trial Register NTR1423. Ausführliche Beschreibung

Gespeichert in:

Autor*in:	Radonic, Teodora [verfasserIn] de Witte, Piet Baars, Marieke JH Zwinderman, Aeilko H Mulder, Barbara JM Groenink, Maarten

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	2010

Schlagwörter:	Losartan Marfan Syndrome Aortic Diameter Aortic Dilatation Losartan Treatment

Anmerkung:	© Radonic et al; licensee BioMed Central Ltd. 2010

Übergeordnetes Werk:	Enthalten in: Trials - London : BioMed Central, 2000, 11(2010), 1 vom: 12. Jan.
Übergeordnetes Werk:	volume:11 ; year:2010 ; number:1 ; day:12 ; month:01

Links:	Volltext

DOI / URN:	10.1186/1745-6215-11-3

Katalog-ID:	SPR030052491

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520			\|a Background Marfan syndrome (MFS) is one of the most common systemic disorders of connective tissue with the incidence of approximately 2-3 per 10 000 individuals. Aortic disease, leading to progressive aneurysmal dilatation and dissection is the main cause of morbidity and mortality of Marfan patients. Current treatment (e.g. beta blockers and elective surgery) does postpone but cannot prevent aortic complications in these patients. Recent studies have found Transforming Growth Factor β (TGF β) to be involved in the aortic aneurysm formation. Losartan, an Angiotensin II type 1 receptor blocker inhibits TGFβ in a mouse model of Marfan syndrome leading to inhibition of aortic growth. The main objective of this trial is to assess whether losartan treatment leads to a clinically relevant decrease of aortic dilatation in adult patients with Marfan syndrome. Methods/Design COMPARE study (COzaar in Marfan Patients Reduces aortic Enlargement) is an open-label, randomized, controlled trial with blinded end-points. Treatment with losartan will be compared with no additional treatment after 3 years of follow-up. We will enroll 330 patients with MFS who will be randomly assigned to receive losartan or not. Patients taking beta-blockers will continue taking their standard treatment. The primary end-point is the largest change in aortic diameter at any aortic level measured by means of MRI. Secondary end-points are change in mortality, incidence of dissection, elective aortic surgery, aortic volume, aortic stiffness and ventricular function. We will also investigate gene and protein expression change in the skin under losartan therapy and create prediction models for losartan-treatment response and aortic dilatation. Discussion The COMPARE study will provide important evidence of effects of losartan treatment in adult Marfan patient population. We expect losartan to significantly reduce the occurrence and progression of aortic dilatation. This trial investigates a wide spectrum of clinical, genetic and biochemical effects of losartan aiming to provide further insight in the pathogenesis and treatment of Marfan syndrome. Trial registration Netherlands Trial Register NTR1423.
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allfields	10.1186/1745-6215-11-3 doi (DE-627)SPR030052491 (SPR)1745-6215-11-3-e DE-627 ger DE-627 rakwb eng Radonic, Teodora verfasserin aut Losartan therapy in adults with Marfan syndrome: study protocol of the multi-center randomized controlled COMPARE trial 2010 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Radonic et al; licensee BioMed Central Ltd. 2010 Background Marfan syndrome (MFS) is one of the most common systemic disorders of connective tissue with the incidence of approximately 2-3 per 10 000 individuals. Aortic disease, leading to progressive aneurysmal dilatation and dissection is the main cause of morbidity and mortality of Marfan patients. Current treatment (e.g. beta blockers and elective surgery) does postpone but cannot prevent aortic complications in these patients. Recent studies have found Transforming Growth Factor β (TGF β) to be involved in the aortic aneurysm formation. Losartan, an Angiotensin II type 1 receptor blocker inhibits TGFβ in a mouse model of Marfan syndrome leading to inhibition of aortic growth. The main objective of this trial is to assess whether losartan treatment leads to a clinically relevant decrease of aortic dilatation in adult patients with Marfan syndrome. Methods/Design COMPARE study (COzaar in Marfan Patients Reduces aortic Enlargement) is an open-label, randomized, controlled trial with blinded end-points. Treatment with losartan will be compared with no additional treatment after 3 years of follow-up. We will enroll 330 patients with MFS who will be randomly assigned to receive losartan or not. Patients taking beta-blockers will continue taking their standard treatment. The primary end-point is the largest change in aortic diameter at any aortic level measured by means of MRI. Secondary end-points are change in mortality, incidence of dissection, elective aortic surgery, aortic volume, aortic stiffness and ventricular function. We will also investigate gene and protein expression change in the skin under losartan therapy and create prediction models for losartan-treatment response and aortic dilatation. Discussion The COMPARE study will provide important evidence of effects of losartan treatment in adult Marfan patient population. We expect losartan to significantly reduce the occurrence and progression of aortic dilatation. This trial investigates a wide spectrum of clinical, genetic and biochemical effects of losartan aiming to provide further insight in the pathogenesis and treatment of Marfan syndrome. Trial registration Netherlands Trial Register NTR1423. Losartan (dpeaa)DE-He213 Marfan Syndrome (dpeaa)DE-He213 Aortic Diameter (dpeaa)DE-He213 Aortic Dilatation (dpeaa)DE-He213 Losartan Treatment (dpeaa)DE-He213 de Witte, Piet aut Baars, Marieke JH aut Zwinderman, Aeilko H aut Mulder, Barbara JM aut Groenink, Maarten aut Enthalten in Trials London : BioMed Central, 2000 11(2010), 1 vom: 12. Jan. (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:11 year:2010 number:1 day:12 month:01 https://dx.doi.org/10.1186/1745-6215-11-3 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 11 2010 1 12 01
spelling	10.1186/1745-6215-11-3 doi (DE-627)SPR030052491 (SPR)1745-6215-11-3-e DE-627 ger DE-627 rakwb eng Radonic, Teodora verfasserin aut Losartan therapy in adults with Marfan syndrome: study protocol of the multi-center randomized controlled COMPARE trial 2010 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Radonic et al; licensee BioMed Central Ltd. 2010 Background Marfan syndrome (MFS) is one of the most common systemic disorders of connective tissue with the incidence of approximately 2-3 per 10 000 individuals. Aortic disease, leading to progressive aneurysmal dilatation and dissection is the main cause of morbidity and mortality of Marfan patients. Current treatment (e.g. beta blockers and elective surgery) does postpone but cannot prevent aortic complications in these patients. Recent studies have found Transforming Growth Factor β (TGF β) to be involved in the aortic aneurysm formation. Losartan, an Angiotensin II type 1 receptor blocker inhibits TGFβ in a mouse model of Marfan syndrome leading to inhibition of aortic growth. The main objective of this trial is to assess whether losartan treatment leads to a clinically relevant decrease of aortic dilatation in adult patients with Marfan syndrome. Methods/Design COMPARE study (COzaar in Marfan Patients Reduces aortic Enlargement) is an open-label, randomized, controlled trial with blinded end-points. Treatment with losartan will be compared with no additional treatment after 3 years of follow-up. We will enroll 330 patients with MFS who will be randomly assigned to receive losartan or not. Patients taking beta-blockers will continue taking their standard treatment. The primary end-point is the largest change in aortic diameter at any aortic level measured by means of MRI. Secondary end-points are change in mortality, incidence of dissection, elective aortic surgery, aortic volume, aortic stiffness and ventricular function. We will also investigate gene and protein expression change in the skin under losartan therapy and create prediction models for losartan-treatment response and aortic dilatation. Discussion The COMPARE study will provide important evidence of effects of losartan treatment in adult Marfan patient population. We expect losartan to significantly reduce the occurrence and progression of aortic dilatation. This trial investigates a wide spectrum of clinical, genetic and biochemical effects of losartan aiming to provide further insight in the pathogenesis and treatment of Marfan syndrome. Trial registration Netherlands Trial Register NTR1423. Losartan (dpeaa)DE-He213 Marfan Syndrome (dpeaa)DE-He213 Aortic Diameter (dpeaa)DE-He213 Aortic Dilatation (dpeaa)DE-He213 Losartan Treatment (dpeaa)DE-He213 de Witte, Piet aut Baars, Marieke JH aut Zwinderman, Aeilko H aut Mulder, Barbara JM aut Groenink, Maarten aut Enthalten in Trials London : BioMed Central, 2000 11(2010), 1 vom: 12. Jan. (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:11 year:2010 number:1 day:12 month:01 https://dx.doi.org/10.1186/1745-6215-11-3 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 11 2010 1 12 01
allfields_unstemmed	10.1186/1745-6215-11-3 doi (DE-627)SPR030052491 (SPR)1745-6215-11-3-e DE-627 ger DE-627 rakwb eng Radonic, Teodora verfasserin aut Losartan therapy in adults with Marfan syndrome: study protocol of the multi-center randomized controlled COMPARE trial 2010 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Radonic et al; licensee BioMed Central Ltd. 2010 Background Marfan syndrome (MFS) is one of the most common systemic disorders of connective tissue with the incidence of approximately 2-3 per 10 000 individuals. Aortic disease, leading to progressive aneurysmal dilatation and dissection is the main cause of morbidity and mortality of Marfan patients. Current treatment (e.g. beta blockers and elective surgery) does postpone but cannot prevent aortic complications in these patients. Recent studies have found Transforming Growth Factor β (TGF β) to be involved in the aortic aneurysm formation. Losartan, an Angiotensin II type 1 receptor blocker inhibits TGFβ in a mouse model of Marfan syndrome leading to inhibition of aortic growth. The main objective of this trial is to assess whether losartan treatment leads to a clinically relevant decrease of aortic dilatation in adult patients with Marfan syndrome. Methods/Design COMPARE study (COzaar in Marfan Patients Reduces aortic Enlargement) is an open-label, randomized, controlled trial with blinded end-points. Treatment with losartan will be compared with no additional treatment after 3 years of follow-up. We will enroll 330 patients with MFS who will be randomly assigned to receive losartan or not. Patients taking beta-blockers will continue taking their standard treatment. The primary end-point is the largest change in aortic diameter at any aortic level measured by means of MRI. Secondary end-points are change in mortality, incidence of dissection, elective aortic surgery, aortic volume, aortic stiffness and ventricular function. We will also investigate gene and protein expression change in the skin under losartan therapy and create prediction models for losartan-treatment response and aortic dilatation. Discussion The COMPARE study will provide important evidence of effects of losartan treatment in adult Marfan patient population. We expect losartan to significantly reduce the occurrence and progression of aortic dilatation. This trial investigates a wide spectrum of clinical, genetic and biochemical effects of losartan aiming to provide further insight in the pathogenesis and treatment of Marfan syndrome. Trial registration Netherlands Trial Register NTR1423. Losartan (dpeaa)DE-He213 Marfan Syndrome (dpeaa)DE-He213 Aortic Diameter (dpeaa)DE-He213 Aortic Dilatation (dpeaa)DE-He213 Losartan Treatment (dpeaa)DE-He213 de Witte, Piet aut Baars, Marieke JH aut Zwinderman, Aeilko H aut Mulder, Barbara JM aut Groenink, Maarten aut Enthalten in Trials London : BioMed Central, 2000 11(2010), 1 vom: 12. Jan. (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:11 year:2010 number:1 day:12 month:01 https://dx.doi.org/10.1186/1745-6215-11-3 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 11 2010 1 12 01
allfieldsGer	10.1186/1745-6215-11-3 doi (DE-627)SPR030052491 (SPR)1745-6215-11-3-e DE-627 ger DE-627 rakwb eng Radonic, Teodora verfasserin aut Losartan therapy in adults with Marfan syndrome: study protocol of the multi-center randomized controlled COMPARE trial 2010 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Radonic et al; licensee BioMed Central Ltd. 2010 Background Marfan syndrome (MFS) is one of the most common systemic disorders of connective tissue with the incidence of approximately 2-3 per 10 000 individuals. Aortic disease, leading to progressive aneurysmal dilatation and dissection is the main cause of morbidity and mortality of Marfan patients. Current treatment (e.g. beta blockers and elective surgery) does postpone but cannot prevent aortic complications in these patients. Recent studies have found Transforming Growth Factor β (TGF β) to be involved in the aortic aneurysm formation. Losartan, an Angiotensin II type 1 receptor blocker inhibits TGFβ in a mouse model of Marfan syndrome leading to inhibition of aortic growth. The main objective of this trial is to assess whether losartan treatment leads to a clinically relevant decrease of aortic dilatation in adult patients with Marfan syndrome. Methods/Design COMPARE study (COzaar in Marfan Patients Reduces aortic Enlargement) is an open-label, randomized, controlled trial with blinded end-points. Treatment with losartan will be compared with no additional treatment after 3 years of follow-up. We will enroll 330 patients with MFS who will be randomly assigned to receive losartan or not. Patients taking beta-blockers will continue taking their standard treatment. The primary end-point is the largest change in aortic diameter at any aortic level measured by means of MRI. Secondary end-points are change in mortality, incidence of dissection, elective aortic surgery, aortic volume, aortic stiffness and ventricular function. We will also investigate gene and protein expression change in the skin under losartan therapy and create prediction models for losartan-treatment response and aortic dilatation. Discussion The COMPARE study will provide important evidence of effects of losartan treatment in adult Marfan patient population. We expect losartan to significantly reduce the occurrence and progression of aortic dilatation. This trial investigates a wide spectrum of clinical, genetic and biochemical effects of losartan aiming to provide further insight in the pathogenesis and treatment of Marfan syndrome. Trial registration Netherlands Trial Register NTR1423. Losartan (dpeaa)DE-He213 Marfan Syndrome (dpeaa)DE-He213 Aortic Diameter (dpeaa)DE-He213 Aortic Dilatation (dpeaa)DE-He213 Losartan Treatment (dpeaa)DE-He213 de Witte, Piet aut Baars, Marieke JH aut Zwinderman, Aeilko H aut Mulder, Barbara JM aut Groenink, Maarten aut Enthalten in Trials London : BioMed Central, 2000 11(2010), 1 vom: 12. Jan. (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:11 year:2010 number:1 day:12 month:01 https://dx.doi.org/10.1186/1745-6215-11-3 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 11 2010 1 12 01
allfieldsSound	10.1186/1745-6215-11-3 doi (DE-627)SPR030052491 (SPR)1745-6215-11-3-e DE-627 ger DE-627 rakwb eng Radonic, Teodora verfasserin aut Losartan therapy in adults with Marfan syndrome: study protocol of the multi-center randomized controlled COMPARE trial 2010 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Radonic et al; licensee BioMed Central Ltd. 2010 Background Marfan syndrome (MFS) is one of the most common systemic disorders of connective tissue with the incidence of approximately 2-3 per 10 000 individuals. Aortic disease, leading to progressive aneurysmal dilatation and dissection is the main cause of morbidity and mortality of Marfan patients. Current treatment (e.g. beta blockers and elective surgery) does postpone but cannot prevent aortic complications in these patients. Recent studies have found Transforming Growth Factor β (TGF β) to be involved in the aortic aneurysm formation. Losartan, an Angiotensin II type 1 receptor blocker inhibits TGFβ in a mouse model of Marfan syndrome leading to inhibition of aortic growth. The main objective of this trial is to assess whether losartan treatment leads to a clinically relevant decrease of aortic dilatation in adult patients with Marfan syndrome. Methods/Design COMPARE study (COzaar in Marfan Patients Reduces aortic Enlargement) is an open-label, randomized, controlled trial with blinded end-points. Treatment with losartan will be compared with no additional treatment after 3 years of follow-up. We will enroll 330 patients with MFS who will be randomly assigned to receive losartan or not. Patients taking beta-blockers will continue taking their standard treatment. The primary end-point is the largest change in aortic diameter at any aortic level measured by means of MRI. Secondary end-points are change in mortality, incidence of dissection, elective aortic surgery, aortic volume, aortic stiffness and ventricular function. We will also investigate gene and protein expression change in the skin under losartan therapy and create prediction models for losartan-treatment response and aortic dilatation. Discussion The COMPARE study will provide important evidence of effects of losartan treatment in adult Marfan patient population. We expect losartan to significantly reduce the occurrence and progression of aortic dilatation. This trial investigates a wide spectrum of clinical, genetic and biochemical effects of losartan aiming to provide further insight in the pathogenesis and treatment of Marfan syndrome. Trial registration Netherlands Trial Register NTR1423. Losartan (dpeaa)DE-He213 Marfan Syndrome (dpeaa)DE-He213 Aortic Diameter (dpeaa)DE-He213 Aortic Dilatation (dpeaa)DE-He213 Losartan Treatment (dpeaa)DE-He213 de Witte, Piet aut Baars, Marieke JH aut Zwinderman, Aeilko H aut Mulder, Barbara JM aut Groenink, Maarten aut Enthalten in Trials London : BioMed Central, 2000 11(2010), 1 vom: 12. Jan. (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:11 year:2010 number:1 day:12 month:01 https://dx.doi.org/10.1186/1745-6215-11-3 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 11 2010 1 12 01
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title	Losartan therapy in adults with Marfan syndrome: study protocol of the multi-center randomized controlled COMPARE trial
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title_full	Losartan therapy in adults with Marfan syndrome: study protocol of the multi-center randomized controlled COMPARE trial
author_sort	Radonic, Teodora
journal	Trials
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author_browse	Radonic, Teodora de Witte, Piet Baars, Marieke JH Zwinderman, Aeilko H Mulder, Barbara JM Groenink, Maarten
container_volume	11
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author-letter	Radonic, Teodora
doi_str_mv	10.1186/1745-6215-11-3
title_sort	losartan therapy in adults with marfan syndrome: study protocol of the multi-center randomized controlled compare trial
title_auth	Losartan therapy in adults with Marfan syndrome: study protocol of the multi-center randomized controlled COMPARE trial
abstract	Background Marfan syndrome (MFS) is one of the most common systemic disorders of connective tissue with the incidence of approximately 2-3 per 10 000 individuals. Aortic disease, leading to progressive aneurysmal dilatation and dissection is the main cause of morbidity and mortality of Marfan patients. Current treatment (e.g. beta blockers and elective surgery) does postpone but cannot prevent aortic complications in these patients. Recent studies have found Transforming Growth Factor β (TGF β) to be involved in the aortic aneurysm formation. Losartan, an Angiotensin II type 1 receptor blocker inhibits TGFβ in a mouse model of Marfan syndrome leading to inhibition of aortic growth. The main objective of this trial is to assess whether losartan treatment leads to a clinically relevant decrease of aortic dilatation in adult patients with Marfan syndrome. Methods/Design COMPARE study (COzaar in Marfan Patients Reduces aortic Enlargement) is an open-label, randomized, controlled trial with blinded end-points. Treatment with losartan will be compared with no additional treatment after 3 years of follow-up. We will enroll 330 patients with MFS who will be randomly assigned to receive losartan or not. Patients taking beta-blockers will continue taking their standard treatment. The primary end-point is the largest change in aortic diameter at any aortic level measured by means of MRI. Secondary end-points are change in mortality, incidence of dissection, elective aortic surgery, aortic volume, aortic stiffness and ventricular function. We will also investigate gene and protein expression change in the skin under losartan therapy and create prediction models for losartan-treatment response and aortic dilatation. Discussion The COMPARE study will provide important evidence of effects of losartan treatment in adult Marfan patient population. We expect losartan to significantly reduce the occurrence and progression of aortic dilatation. This trial investigates a wide spectrum of clinical, genetic and biochemical effects of losartan aiming to provide further insight in the pathogenesis and treatment of Marfan syndrome. Trial registration Netherlands Trial Register NTR1423. © Radonic et al; licensee BioMed Central Ltd. 2010
abstractGer	Background Marfan syndrome (MFS) is one of the most common systemic disorders of connective tissue with the incidence of approximately 2-3 per 10 000 individuals. Aortic disease, leading to progressive aneurysmal dilatation and dissection is the main cause of morbidity and mortality of Marfan patients. Current treatment (e.g. beta blockers and elective surgery) does postpone but cannot prevent aortic complications in these patients. Recent studies have found Transforming Growth Factor β (TGF β) to be involved in the aortic aneurysm formation. Losartan, an Angiotensin II type 1 receptor blocker inhibits TGFβ in a mouse model of Marfan syndrome leading to inhibition of aortic growth. The main objective of this trial is to assess whether losartan treatment leads to a clinically relevant decrease of aortic dilatation in adult patients with Marfan syndrome. Methods/Design COMPARE study (COzaar in Marfan Patients Reduces aortic Enlargement) is an open-label, randomized, controlled trial with blinded end-points. Treatment with losartan will be compared with no additional treatment after 3 years of follow-up. We will enroll 330 patients with MFS who will be randomly assigned to receive losartan or not. Patients taking beta-blockers will continue taking their standard treatment. The primary end-point is the largest change in aortic diameter at any aortic level measured by means of MRI. Secondary end-points are change in mortality, incidence of dissection, elective aortic surgery, aortic volume, aortic stiffness and ventricular function. We will also investigate gene and protein expression change in the skin under losartan therapy and create prediction models for losartan-treatment response and aortic dilatation. Discussion The COMPARE study will provide important evidence of effects of losartan treatment in adult Marfan patient population. We expect losartan to significantly reduce the occurrence and progression of aortic dilatation. This trial investigates a wide spectrum of clinical, genetic and biochemical effects of losartan aiming to provide further insight in the pathogenesis and treatment of Marfan syndrome. Trial registration Netherlands Trial Register NTR1423. © Radonic et al; licensee BioMed Central Ltd. 2010
abstract_unstemmed	Background Marfan syndrome (MFS) is one of the most common systemic disorders of connective tissue with the incidence of approximately 2-3 per 10 000 individuals. Aortic disease, leading to progressive aneurysmal dilatation and dissection is the main cause of morbidity and mortality of Marfan patients. Current treatment (e.g. beta blockers and elective surgery) does postpone but cannot prevent aortic complications in these patients. Recent studies have found Transforming Growth Factor β (TGF β) to be involved in the aortic aneurysm formation. Losartan, an Angiotensin II type 1 receptor blocker inhibits TGFβ in a mouse model of Marfan syndrome leading to inhibition of aortic growth. The main objective of this trial is to assess whether losartan treatment leads to a clinically relevant decrease of aortic dilatation in adult patients with Marfan syndrome. Methods/Design COMPARE study (COzaar in Marfan Patients Reduces aortic Enlargement) is an open-label, randomized, controlled trial with blinded end-points. Treatment with losartan will be compared with no additional treatment after 3 years of follow-up. We will enroll 330 patients with MFS who will be randomly assigned to receive losartan or not. Patients taking beta-blockers will continue taking their standard treatment. The primary end-point is the largest change in aortic diameter at any aortic level measured by means of MRI. Secondary end-points are change in mortality, incidence of dissection, elective aortic surgery, aortic volume, aortic stiffness and ventricular function. We will also investigate gene and protein expression change in the skin under losartan therapy and create prediction models for losartan-treatment response and aortic dilatation. Discussion The COMPARE study will provide important evidence of effects of losartan treatment in adult Marfan patient population. We expect losartan to significantly reduce the occurrence and progression of aortic dilatation. This trial investigates a wide spectrum of clinical, genetic and biochemical effects of losartan aiming to provide further insight in the pathogenesis and treatment of Marfan syndrome. Trial registration Netherlands Trial Register NTR1423. © Radonic et al; licensee BioMed Central Ltd. 2010
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container_issue	1
title_short	Losartan therapy in adults with Marfan syndrome: study protocol of the multi-center randomized controlled COMPARE trial
url	https://dx.doi.org/10.1186/1745-6215-11-3
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author2	de Witte, Piet Baars, Marieke JH Zwinderman, Aeilko H Mulder, Barbara JM Groenink, Maarten
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up_date	2024-07-03T13:35:13.350Z
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