Losartan after aortic valve replacement to help the heart recover

Effect of Losartan on the Neurohumoral Axis and Ventricular Remodeling of Patients With Severe Aortic Regurgitation Undergoing Valve Surgery

This trial will try if taking losartan after aortic valve replacement helps the heart shrink back to a healthier size and improve recovery in adults who had severe aortic regurgitation.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: University of Sao Paulo General Hospital (Academic / other)
• Locations: 1 site (São Paulo, São Paulo)
• Trial ID: NCT07099859 on ClinicalTrials.gov

What this trial studies

Adults who have undergone aortic valve replacement for severe aortic regurgitation are given either losartan 50 mg or a matching placebo after surgery and followed over time. The study measures neurohumoral markers (including natriuretic peptides) and uses cardiac imaging to track ventricular size and function to quantify reverse remodeling. Patients with conditions that could confound results or make losartan unsafe are excluded, and outcomes in the losartan group will be compared with placebo. The trial is a Phase 4 effort conducted at the Heart Institute of the University of São Paulo to address a gap in evidence about postoperative medical therapy for valvular cardiomyopathy.

Who should consider this trial

Good fit: Adults (age ≥18) in the postoperative period after aortic valve replacement for severe aortic regurgitation who can give informed consent and do not have the listed contraindications are ideal candidates.

Not a fit: Patients with ischemic cardiomyopathy, other significant concomitant valvular disease, recent surgery for cardiogenic shock or infective endocarditis, severe kidney dysfunction (eGFR <30), low blood pressure, high potassium, pregnancy, or known losartan intolerance are excluded and unlikely to receive benefit from this intervention.

Why it matters

Potential benefit: If successful, losartan could speed or improve reverse ventricular remodeling and functional recovery after valve surgery for severe aortic regurgitation.

How similar studies have performed: Drugs that target the neurohumoral axis like ARBs have proven benefit in classic heart failure but have not been specifically tested in postoperative valvular cardiomyopathy, so this application remains largely untested.

Eligibility criteria

Inclusion criteria:

* Age ≥ 18 years;
* Postoperative period of aortic valve replacement surgery due to severe aortic regurgitation of any etiology;
* Signed Informed Consent Form.

Exclusion Criteria:

To avoid potential bias in data interpretation, the following patients will be excluded:

* Those who underwent cardiac surgery in the context of cardiogenic shock or infective endocarditis;
* Patients with ischemic cardiomyopathy;
* Patients with other significant concomitant valvular diseases.

Patients with conditions where losartan use may be harmful will also be excluded, including:

* Chronic kidney disease with an estimated glomerular filtration rate (eGFR \< 30 ml/min/1.73 m²);
* Systolic blood pressure (SBP) \< 90 mmHg at the time of randomization;
* Elevated serum potassium (K \> 5.5 mEq/L) at the time of randomization;
* Pregnancy;
* Known intolerance or allergy to losartan.

Where this trial is running

São Paulo, São Paulo

• Heart Institute of the School of Medicine of the University of São Paulo — São Paulo, São Paulo, Brazil (Recruiting)

Study contacts

• Principal investigator: Vitor E. E. Rosa, MD, PhD — Heart Institute of the School of Medicine of the University of São Paulo
• Study coordinator: Vitor E. E. Rosa, MD, PhD

Conditions Heart Valve Diseases; Left Ventricle Remodeling; Aortic Regurgitation Disease; Heart Failure Congestive; Natriuretic Peptide, Brain; aortic regurgitation; valve disease; heart surgery