Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

Renin-angiotensin System Blockade Benefits in Clinical Evolution and Ventricular Remodeling After Transcatheter Aortic Valve Implantation (RASTAVI) (RASTAVI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03201185
Recruitment Status : Recruiting
First Posted : June 28, 2017
Last Update Posted : December 17, 2019
Sponsor:
Information provided by (Responsible Party):
Carlos Baladron, PhD, Hospital Clínico Universitario de Valladolid

Brief Summary:
The investigators aim to demonstrate that ramipril after transcatheter aortic valve implantation has benefits in terms of prognosis, cardiovascular events and ventricular remodeling (MRI).

Condition or disease Intervention/treatment Phase
Transcatheter Aortic Valve Replacemen Angiotensin-Converting Enzyme Inhibitors Drug: Ramipril Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 336 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Open-label
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Beneficio Del Bloqueo Del Sistema Renina-angiotensina Sobre la evolución clínica y el Remodelado Ventricular Tras la colocación de Una prótesis percutánea aórtica (RASTAVI)
Actual Study Start Date : February 10, 2018
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Ramipril

Arm Intervention/treatment
Experimental: Ramipril
After transcatheter aortic valve implantation, patients will receive ramipril before discharge plus conventional treatment (in patients without ACEI).
Drug: Ramipril
Initial dose: 2,5 mg. Up-titrated at one month to 5 mg and 10 mg at three months (following clinical practice recommendations for up-titration). Target dose: 10 mg (or maximum tolerated dose).

No Intervention: No intervention
Conventional treatment after transcatheter aortic valve implantation



Primary Outcome Measures :
  1. Number of participants that had the occurrence of cardiovascular events (cardiac death, heart failure admission and stroke). [ Time Frame: Up to 36 months ]
    Number of participants that had first occurrence of cardiovascular events, which is defined as either cardiac death or heart failure hospitalization or stroke


Secondary Outcome Measures :
  1. Changes in left ventricular remodeling at 12 months assessed by cardiac MRI. Changes in left ventricle ejection fraction, ventricular dimenssions, ventricular mass and myocardial fibrosis will be measured [ Time Frame: Up to 12 months ]
    Myocardial fibrosis will be measured in grams

  2. Change from baseline to month 12 for the six minutes walk test in order to assess functional capacity. [ Time Frame: Up to 12 months ]
    Assessed by six minutes walk test at 12 months

  3. Number of patients dead due to cardiac causes. [ Time Frame: Up to 12 and 36 months ]
    Number of patients dead due to cardiac causes at 12 and 36 months.

  4. Number of patients admitted due to heart failure. [ Time Frame: Up to 12 and 36 months ]
    Number of patients admitted due to heart failure at 12 and 36 months.

  5. Number of patients with stroke (Defined as compatible symptoms or confirmed by imaging technique: MRI or CT) during the trial. [ Time Frame: Up to 12 and 36 months ]
    Number of patients with stroke during the trial at 12 and 36 months.

  6. Number of patients - All-cause mortality [ Time Frame: Up to 12 and 36 months ]
    All-cause mortality measures how many patients had this event at 12 and 36 months.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Transcatheter aortic valve implantation due to severe aortic stenosis.
  • Patients must give written informed consent.

Exclusion Criteria:

  • Severe mitral valvulopathy.
  • Reduced left ventricular ejection fraction (LVEF < 40%) with myocardial infarction or dilated cardiomyopathy.
  • Patients on an ACEI or an ARB the last 3 months.
  • History of hypersensitivity or allergy to any of the study drugs, drugs of similar chemical classes, ACEIs, ARBs, or NEP inhibitors as well as known or suspected contraindications to the study drugs.
  • Non-MR-conditional cardiac devices.
  • Estimated GFR < 30 ml/min. GFR between 30 and 50 ml/min will not receive gadolinium during MRI.
  • Systolic blood pressure < 100 mmHg or diastolic < 40 mmHg.
  • Pregnant women.
  • Participating in other investigational trial at the time of enrollment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03201185


Locations
Layout table for location information
Spain
Hospital Clínico Universitario de Valladolid Recruiting
Valladolid, Spain, 47005
Contact: Luis Varela-Falcón, Dr    983420000 ext 86571    lhvf86@hotmail.com   
Sponsors and Collaborators
Hospital Clínico Universitario de Valladolid

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Carlos Baladron, PhD, Research Coordinator, Cardiology, Hospital Clínico Universitario de Valladolid
ClinicalTrials.gov Identifier: NCT03201185    
Other Study ID Numbers: HCUValladolid
First Posted: June 28, 2017    Key Record Dates
Last Update Posted: December 17, 2019
Last Verified: December 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Carlos Baladron, PhD, Hospital Clínico Universitario de Valladolid:
Cardiovascular events
Ventricular remodeling
Additional relevant MeSH terms:
Layout table for MeSH terms
Ventricular Remodeling
Pathological Conditions, Anatomical
Ramipril
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents