A Phase 4 interventional study of Losartan 50 mg and Placebo in Heart Valve Diseases, Left Ventricle Remodeling and Aortic Regurgitation Disease, sponsored by Vitor Emer Egypto Rosa. Recruiting at 1 site in Brazil. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-08-01.
Sponsored by Vitor Emer Egypto Rosa · Phase 4, Interventional, and Treatment
Why Is This Study Important? The heart has valves that help control blood flow. Aortic regurgitation (AR) is a condition where one of these valves (the aortic valve) doesn't close properly, causing blood to leak back into the heart. Over time, this makes the heart work harder and grow larger (remodeling) to keep up. Many patients with severe AR need valve replacement surgery to fix this problem.
After surgery, the heart doesn't have to work as hard, and over time, it can shrink back to a healthier size (reverse remodeling). However, doctors don't know if medications can help speed up or improve this healing process. This study aims to find out if a common blood pressure medication, losartan, can help the heart recover better after surgery.
What Do the Investigators Already Know? Doctors often prescribe medications like ACE inhibitors, angiotensin receptor blockers (ARBs), beta-blockers, and spironolactone to people with heart failure because these drugs help the heart function better and prevent worsening disease. However, these medications haven't been studied in people with valve disease because most major research studies excluded patients with valve problems.
Even though there is not strong evidence, many doctors prescribe these medications after valve surgery, assuming they might be helpful. But is that really the case? That's the question this study hopes to answer.
What Is This Study About?
This study will test whether losartan, a medication often used for high blood pressure, can help hearts recover better after aortic valve replacement surgery. The researchers will compare two groups of patients:
By comparing these two groups, the study will determine whether losartan helps the heart shrink back to a normal size faster and function better after surgery.
How Will the Study Work? Who? 60 patients with severe AR who are having aortic valve replacement surgery.
How? Patients will be randomly placed into one of the two groups (losartan or placebo).
For how long? Patients will be followed for one year after surgery. What Will Be Measured?
Doctors will check patients four times: before surgery, and 1 month, 3 months, and 12 months after surgery. At each visit, the investigators will measure:
Why Is This Study Exciting? This is the first study to test whether a medication can help the heart heal better after valve surgery. If losartan proves beneficial, it could change how doctors treat patients after surgery and lead to better recovery, stronger hearts, and healthier lives.
Many people with aortic regurgitation have to wait until their symptoms get worse before patients can have surgery. If this study finds that medication can speed up healing, it could help doctors treat valve disease more effectively and improve long-term outcomes for patients.
What Happens Next? If losartan is found to be helpful, this study could lead to larger research trials and, eventually, new treatment guidelines for people who have had aortic valve surgery. If it doesn't help, doctors will know not to prescribe it unnecessarily, preventing unnecessary side effects and costs for patients. Either way, the results will help improve care for people with heart valve disease.
By participating in this study, patients are helping researchers discover new ways to improve heart health and recovery after surgery.
Pharmacological therapy targeting the neurohumoral axis have emerged as the cornerstone of Heart Failure (HF) treatment. The angiotensin-converting enzyme inhibitors, angiotensin receptor blockers (ARBs), spironolactone, beta-blockers and neprilysin inhibitors act on the neurohumoral axis, having prognostic impact with proven benefits in terms of ventricular remodeling, morbidity and mortality. However, these drugs have not been tested in the context of valvular cardiomyopathy, as pivotal studies excluded patients with valve disease. There are robust evidences that medical treatment does not reduce mortality in the preoperative phase of valve disease, acting only on symptom management. However, in the period after valve surgery, there is absence of data regarding benefit of medical therapy focused on the neurohumoral axis. Aortic regurgitation represents a condition characterized by pronounced ventricular remodeling during the asymptomatic phase, often developing significant reverse remodeling after surgery. Consequently, it presents as a very interesting model for studying the impact of renin-angiotensin-aldosterone system inhibition after valve intervention. Currently, clinicians frequently precribe drugs targeting the neurohumoral axis in the postoperative phase for these patients, extrapolating from findings in classical HF studies. However, there is no evidence in the literature for this approach, which is common in clinical practice. Therefore, this study aims to assess the impact of the use of the ARB losartan on neurohumoral remodeling in the postoperative period of patients with aortic regurgitation undergoing valve surgery, measuring NT-proBNP, a natriuretic peptide strongly associated with ventricular remodeling. The primary objective of the study is to compare NT-proBNP values in patients taking losartan 50 mg/day versus placebo in the first 3 months after aortic valve replacement for severe aortic regurgitation. This is a pilot, randomized, double-blind clinical study with a sample of 60 patients, who will be randomized in a 1:1 ratio. Patients in both arms will be assessed at 4 time points: randomization, 1, 3 and 12 months after surgery, undergoing a 6-minute walk test and Short-Form Health Survey (SF-36v2) quality of life questionnaire, laboratory tests including NT-proBNP, electrolytes and renal function, as well as a complete echocardiographic evaluation.
169 studies on the registry are indexed under Aortic Valve Insufficiency; 54 are open to participants now.
This study's planned enrollment of 60 is below the median of 123 across 92 interventional studies indexed under Aortic Valve Insufficiency.
Browse Aortic Valve Insufficiency studies →This is the only study on the registry with Vitor Emer Egypto Rosa as lead sponsor.
Compared within Aortic Valve Insufficiency, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Heart Valve Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
To avoid potential bias in data interpretation, the following patients will be excluded:
Patients with conditions where losartan use may be harmful will also be excluded, including:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
losartan 50 mg/day
Drug: Losartan 50 mg
placebo group
Drug: Placebo
Losartan 50 mg per day
Placebo 1 pill per day
Change of NT-proBNP during the first 3 months after aortic valve surgery in patients with severe aortic regurgitation.
The primary outcome of the study will be to evaluate the reduction of NT-proBNP during the first 3 months after aortic valve surgery in patients with severe aortic regurgitation.
Time frame: 3 months
Evaluation of the effects of losartan on NT-proBNP levels after aortic valve surgery in 1 and 12 months.
-NT-proBNP (pg/ml) reduction at 1 and 12 months, compared to pre-discharge values.
Time frame: 12 months
Evaluation of the effects of losartan on cardiac remodeling after aortic valve surgery in 1, 3 and 12 months.
-Left ventricular reverse remodeling: ejection fraction (%) at 1, 3, and 12 months.
Time frame: 1, 3, and 12 months
Evaluation of the effects of losartan on quality of life after aortic valve surgery in 1, 3 and 12 months.
-Quality of life questionnare: Short-Form Health Survey (SF-36v2) with values ranging from 0 to 100 points (100 = best possible health status) at 1, 3, and 12 months.
Time frame: 1, 3 and 12 months
Evaluation of the effects of losartan on functional capacity after aortic valve surgery in 1, 3 and 12 months
\- 6-minute walk test (meters) at 1, 3, and 12 months.
Time frame: 1, 3 and 12 months
Evaluation of the effects of losartan on kidney function after aortic valve surgery in 1, 3 and 12 months.
-Acute kidney injury (KDIGO criteria) at 1, 3, and 12 months: Stage 1: 1.5-1.9× baseline or ≥0.3 mg/dL increase Stage 2: 2.0-2.9× baseline Stage 3: 3× baseline, ≥4.0 mg/dL increase, dialysis, or clearance \<35ml/min/1.73m² -Hyperkalemia (K \> 5.6 mEq/L)
Time frame: 1, 3 and 12 months
Evaluation of the effects of losartan on major cardiovascular events after aortic valve surgery in 1, 3 and 12 months.
* Rate of cardiac rehospitalization, cardiovascular and all-cause mortality * Rate of MACE: myocardial infarction, stroke, or cardiovascular death.
Time frame: 1, 3 and 12 months
Evaluation of the effects of losartan on cardiac remodeling after aortic valve surgery in 1, 3 and 12 months.
-Left ventricular reverse remodeling: left ventricular mass index (g/m2) at 1, 3, and 12 months.
Time frame: 1, 3, and 12 months
Evaluation of the effects of losartan on cardiac remodeling after aortic valve surgery in 1, 3 and 12 months.
-Left ventricular reverse remodeling: left ventricular diameters (mm) at 1, 3, and 12 months.
Time frame: 1, 3, and 12 months
Evaluation of the effects of losartan on cardiac remodeling after aortic valve surgery in 1, 3 and 12 months.
-Left ventricular reverse remodeling: left ventricular volumes (ml) at 1, 3, and 12 months.
Time frame: 1, 3, and 12 months
Evaluation of the effects of losartan on cardiac remodeling after aortic valve surgery in 1, 3 and 12 months.
-Left ventricular reverse remodeling: left ventricular global longitudinal strain (%) at 1, 3, and 12 months.
Time frame: 1, 3, and 12 months
Evaluation of the effects of losartan on cardiac remodeling after aortic valve surgery in 1, 3 and 12 months.
-Left ventricular reverse remodeling: left ventricular myocardial work (GWI: global left ventricular myocardial work index-mmHg%) at 1, 3, and 12 months.
Time frame: 1, 3, and 12 months
Plan to share: Yes
Supporting information: Study protocol
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Studies of the drug tested here: Losartan