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New treatment option for Heart Valve Diseases
Official title Effect of Losartan on the Neurohumoral Axis and Ventricular Remodeling of Patients With Severe Aortic Regurgitation Undergoing Valve Surgery.
ClinicalTrials.gov ID: NCT07099859
What this study is testing
What is Losartan 50 mg?
Losartan 50 mg is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for heart valve diseases.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Why Is This Study Important? The heart has valves that help control blood flow.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- Age ≥ 18 years;
- Postoperative period of aortic valve replacement surgery due to severe aortic regurgitation of any etiology;
- Signed Informed Consent Form.
You likely can't join if
- 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...
- 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;
See the full eligibility criteria
- Age ≥ 18 years;
- Postoperative period of aortic valve replacement surgery due to severe aortic regurgitation of any etiology;
- Signed Informed Consent Form.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- São Paulo, São Paulo, Brazil
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include São Paulo, São Paulo, Brazil. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.