Medical therapy can improve the biological properties of the chronically failing heart. A new era in the treatment of heart failure.
E J Eichhorn, M R Bristow
https://pubmed.ncbi.nlm.nih.gov/8901684Actively Recruiting
Phase 4
Age: 18Years - 85Years
All Genders
ID07099859
Effect of Losartan on Neurohumoral Axis and Heart Remodeling in Severe Aortic Regurgitation Patients Undergoing Valve Surgery
Led by Vitor Emer Egypto Rosa · Updated on 2025-08-01
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
V
Vitor Emer Egypto Rosa
Lead Sponsor
F
Fundação de Amparo à Pesquisa do Estado de São Paulo
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate whether losartan, a common blood pressure medication, can help the heart recover better after aortic valve replacement surgery in patients with severe aortic regurgitation. This condition causes the aortic valve to leak, making the heart work harder and enlarge. While doctors often use heart failure medications after valve surgery, their effects in valve disease patients have not been studied, and this trial seeks to fill that gap. The study is a pilot, randomized, double-blind trial involving 60 patients who have undergone aortic valve replacement surgery for severe aortic regurgitation. Participants are randomly assigned to take either losartan 50 mg daily or a placebo. The trial lasts for one year, with assessments before surgery and at 1, 3, and 12 months after surgery. Treatments are given daily, and the trial compares heart recovery between the two groups. During the study, patients will have blood tests measuring NT-proBNP, which indicates heart strain, echocardiograms to check heart size and function, 6-minute walk tests to assess physical capacity, and quality of life surveys. Kidney function and electrolyte levels will also be monitored to watch for potential medication side effects. The main measure is the change in NT-proBNP levels within the first 3 months after surgery, and all patients will be followed for one year to observe heart remodeling and overall health outcomes.
CONDITIONS
Brief Title
Effect of Losartan on the Neurohumoral Axis and Ventricular Remodeling of Patients With Severe Aortic Regurgitation Undergoing Valve Surgery.
Who Can Participate
Age: 18Years - 85Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Underwent aortic valve replacement surgery due to severe aortic regurgitation of any cause
- Provided signed informed consent
You will not qualify if you...
- Cardiac surgery performed due to cardiogenic shock or infective endocarditis
- Presence of ischemic cardiomyopathy
- Other significant valvular diseases besides aortic regurgitation
- Chronic kidney disease with estimated glomerular filtration rate less than 30 ml/min/1.73 m²
- Systolic blood pressure below 90 mmHg at randomization
- Elevated serum potassium above 5.5 mEq/L at randomization
- Pregnancy
- Known intolerance or allergy to losartan
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery and Immediate Post-operative Care
Duration - Up to discharge from hospital
Participants undergo aortic valve replacement surgery for severe aortic regurgitation and receive immediate post-operative care.
1 surgical hospitalization
Treatment
Duration - 3 months
Participants take either losartan 50 mg per day or placebo starting after surgery to assess the impact on neurohumoral remodeling and ventricular function.
4 visits: at randomization, 1 month, 3 months, and 12 months after surgery
Follow-up
Duration - Up to 12 months after surgery
Participants are monitored for up to a year after surgery to evaluate long-term effects on cardiac remodeling, quality of life, functional capacity, kidney function, and cardiovascular events.
4 visits: at randomization, 1 month, 3 months, and 12 months after surgery
Trial Site Locations
Total: 1 location
1
Heart Institute of the School of Medicine of the University of São Paulo
São Paulo, São Paulo, Brazil, 05403-000
Actively Recruiting
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Research Team
V
Vitor E. E. Rosa, MD, PhD
M
Mariana P Lopes, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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