Both ramipril and telmisartan reverse indices of early diabetic cardiomyopathy: a comparative study.
Phivos Symeonides, Spyridon Koulouris, Ekaterini Vratsista...
https://pubmed.ncbi.nlm.nih.gov/17113349/Actively Recruiting
Led by Vitor Emer Egypto Rosa · Updated on 2025-08-01
60
Participants Needed
1
Research Sites
N/A
Total Duration
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
Effect of Losartan on the Neurohumoral Axis and Ventricular Remodeling of Patients With Severe Aortic Regurgitation Undergoing Valve Surgery.
V
Vitor E. E. Rosa, MD, PhD
M
Mariana P Lopes, MD
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Vitor Emer Egypto Rosa
Lead Sponsor
Fundação de Amparo à Pesquisa do Estado de São Paulo
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
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
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Have more questions? Get in touch with our team for quick support
Phivos Symeonides, Spyridon Koulouris, Ekaterini Vratsista...
https://pubmed.ncbi.nlm.nih.gov/17113349/E J Eichhorn, M R Bristow
https://pubmed.ncbi.nlm.nih.gov/8901684/Tania Rodriguez-Gabella, Pablo Catalá, Antonio J Muñoz-García...
https://pubmed.ncbi.nlm.nih.gov/31370954/J N Cohn, G Tognoni, Valsartan Heart Failure Trial Investigators
https://pubmed.ncbi.nlm.nih.gov/11759645/Bong Gun Song, Yong Hwan Park, Gu Hyun Kang...
https://pubmed.ncbi.nlm.nih.gov/20861629/James B Young, Mark E Dunlap, Marc A Pfeffer...
https://pubmed.ncbi.nlm.nih.gov/15492298/Rory B Weiner, Aaron L Baggish, Annabel Chen-Tournoux...
https://pubmed.ncbi.nlm.nih.gov/23132825/Marc A Pfeffer, Karl Swedberg, Christopher B Granger...
https://pubmed.ncbi.nlm.nih.gov/13678868/Melissa A Daubert, Kirkwood Adams, Eric Yow...
https://pubmed.ncbi.nlm.nih.gov/30611722/B Pitt, P A Poole-Wilson, R Segal...
https://pubmed.ncbi.nlm.nih.gov/10821361/Vitor Emer Egypto Rosa
Lead Sponsor
Fundação de Amparo à Pesquisa do Estado de São Paulo
Collaborating Sponsor