Q3197002 (Q3197002): Difference between revisions
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(Created claim: summary (P836): BACKGROUND: The placement of an aortic percutaneous prosthesis (AOP) is an excellent and less aggressive alternative than conventional surgical replacement in patients with degenerative aortic stenosis. Despite this, the long-term evolution of these patients is not as favorable as could be expected. Blockage of the renin-angiotensin system has shown that it improves adverse remodeling in severe aortic stenosis and after conventional aortic valve...) |
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BACKGROUND: The placement of an aortic percutaneous prosthesis (AOP) is an excellent and less aggressive alternative than conventional surgical replacement in patients with degenerative aortic stenosis. Despite this, the long-term evolution of these patients is not as favorable as could be expected. Blockage of the renin-angiotensin system has shown that it improves adverse remodeling in severe aortic stenosis and after conventional aortic valve replacement surgery. OBJECTIVE: Check the clinical benefit and adverse ventricular remodeling of the blockage of the renin-angiotensin system after placement of a PPAo. METHODOLOGY: A 1:1 randomised study will be conducted in 336 patients in 7 centers where a severe aortic stenosis is placed. All patients will receive standard treatment. Patients in the active treatment group will also receive ramipril. Randomisation shall be done before registration, after the signing of the informed consent. All patients will have clinical follow-up for 3 years and cardiac megnetic resonance initially after the procedure and per year to assess ventricular remodeling. Events include cardiac death, admission from heart failure, and stroke. Remodeling studies include ventricular dimensions, ejection fraction, ventricular mass, and magnetic resonance fibrosis. (English) | |||||||||||||||
| Property / summary: BACKGROUND: The placement of an aortic percutaneous prosthesis (AOP) is an excellent and less aggressive alternative than conventional surgical replacement in patients with degenerative aortic stenosis. Despite this, the long-term evolution of these patients is not as favorable as could be expected. Blockage of the renin-angiotensin system has shown that it improves adverse remodeling in severe aortic stenosis and after conventional aortic valve replacement surgery. OBJECTIVE: Check the clinical benefit and adverse ventricular remodeling of the blockage of the renin-angiotensin system after placement of a PPAo. METHODOLOGY: A 1:1 randomised study will be conducted in 336 patients in 7 centers where a severe aortic stenosis is placed. All patients will receive standard treatment. Patients in the active treatment group will also receive ramipril. Randomisation shall be done before registration, after the signing of the informed consent. All patients will have clinical follow-up for 3 years and cardiac megnetic resonance initially after the procedure and per year to assess ventricular remodeling. Events include cardiac death, admission from heart failure, and stroke. Remodeling studies include ventricular dimensions, ejection fraction, ventricular mass, and magnetic resonance fibrosis. (English) / rank | |||||||||||||||
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| Property / summary: BACKGROUND: The placement of an aortic percutaneous prosthesis (AOP) is an excellent and less aggressive alternative than conventional surgical replacement in patients with degenerative aortic stenosis. Despite this, the long-term evolution of these patients is not as favorable as could be expected. Blockage of the renin-angiotensin system has shown that it improves adverse remodeling in severe aortic stenosis and after conventional aortic valve replacement surgery. OBJECTIVE: Check the clinical benefit and adverse ventricular remodeling of the blockage of the renin-angiotensin system after placement of a PPAo. METHODOLOGY: A 1:1 randomised study will be conducted in 336 patients in 7 centers where a severe aortic stenosis is placed. All patients will receive standard treatment. Patients in the active treatment group will also receive ramipril. Randomisation shall be done before registration, after the signing of the informed consent. All patients will have clinical follow-up for 3 years and cardiac megnetic resonance initially after the procedure and per year to assess ventricular remodeling. Events include cardiac death, admission from heart failure, and stroke. Remodeling studies include ventricular dimensions, ejection fraction, ventricular mass, and magnetic resonance fibrosis. (English) / qualifier | |||||||||||||||
point in time: 13 October 2021
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Revision as of 23:24, 12 October 2021
Project Q3197002 in Spain
| Language | Label | Description | Also known as |
|---|---|---|---|
| English | No label defined |
Project Q3197002 in Spain |
Statements
41,000.0 Euro
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82,000.0 Euro
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50.0 percent
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1 January 2018
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31 March 2021
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HOSPITAL CLINICO UNIVERSITARIO DE VALLADOLID
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41°39'7.67"N, 4°43'42.82"W
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47186
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ANTECEDENTES: La colocación de una prótesis percutánea aórtica (PPAo) es una alternativa excelente y menos agresiva que la sustitución quirúrgica convencional en pacientes con estenosis aórtica degenerativa. A pesar de ello, la evolución a largo de plazo de estos pacientes no es todo lo favorable que podría esperarse. El bloqueo del sistema renina-angiotensina ha demostrado que mejora el remodelado adverso en la estenosis aórtica severa y tras la cirugía convencional de sustitución valvular aórtica. OBJETIVO: Comprobar el beneficio clínico y sobre el remodelado ventricular adverso del bloqueo del sistema renina-angiotensina tras la colocación de una PPAo. METODOLOGIA: Se hará un estudio aleatorizado 1:1 abierto en 336 pacientes en 7 centros a los que se coloca una PPAo por estenosis aórtica severa. Todos los pacientes recibirán el tratamiento estándar. Los pacientes del grupo de tratamiento activo recibirán además ramipril. La aleatorización se hará antes del alta, tras la firma del consentimiento informado. En todos los pacientes se hará un seguimiento clínico durante 3 años y una resonancia megnética cardíaca inicialmente tras el procedimiento y al año para valorar el remodelado ventricular. Como eventos se incluyen muerte de causa cardíaca, ingreso por insuficiencia cardíaca e ictus. Como estudio de remodelado se incluyen dimensiones ventriculares, fracción de eyección, masa ventricular y fibrosis valorada con resonancia magnética. (Spanish)
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BACKGROUND: The placement of an aortic percutaneous prosthesis (AOP) is an excellent and less aggressive alternative than conventional surgical replacement in patients with degenerative aortic stenosis. Despite this, the long-term evolution of these patients is not as favorable as could be expected. Blockage of the renin-angiotensin system has shown that it improves adverse remodeling in severe aortic stenosis and after conventional aortic valve replacement surgery. OBJECTIVE: Check the clinical benefit and adverse ventricular remodeling of the blockage of the renin-angiotensin system after placement of a PPAo. METHODOLOGY: A 1:1 randomised study will be conducted in 336 patients in 7 centers where a severe aortic stenosis is placed. All patients will receive standard treatment. Patients in the active treatment group will also receive ramipril. Randomisation shall be done before registration, after the signing of the informed consent. All patients will have clinical follow-up for 3 years and cardiac megnetic resonance initially after the procedure and per year to assess ventricular remodeling. Events include cardiac death, admission from heart failure, and stroke. Remodeling studies include ventricular dimensions, ejection fraction, ventricular mass, and magnetic resonance fibrosis. (English)
13 October 2021
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Valladolid
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Identifiers
PI17_02237
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