Losartan after aortic valve replacement to help the heart recover

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: vitor.rosa@hc.fm.usp.br
• Phone: 551126613653

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.