Omapatrilat Versus Enalapril Randomized Trial of Utility in Reducing Events (OVERTURE)

Not Applicable

• Conditions: -I500 Congestive heart failure; Congestive heart failure; I500

• Registration Number: PER-026-99
• Lead Sponsor: BRISTOL MYERS SQUIBB PERÚ S.A.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 1999-12-30
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Age>18years
2.Men or women. Women may not be pregnant or nursing. Women of child bearing potential (WOCBP) are eligible if they are practicing effective contraceptive measures.
3.Chronic heart failure of NYHA Functional Class II, III or IV in severity for at least 2 months. Subjects with no symptoms attributable to heart failure (Class I) are not eligible.
4.Hospitalization for worsening heart failure within the past 12 months.
5.The following medications are required, recommended or allowed at the time of enrolment into the study: Diuretics, ACE Inhibitors, Beta-blockers, Angiotensin II receptor blockers, Other Cardiac Therapies.
6.Willing and able to give informed consent.
7.Evidence by invasive or noninvasive cardiac imaging of left ventricular systolic dysfunction.

Exclusion Criteria

1.Previous intolerance to ACE inhibitors, as indicated by a history of discontinuation of ACE-I due to urticaria, cough, bronchospasm, or angioedema.
2.Hemodynamically significant primary cardiac valvular disease, hypertrophic or restrictive cardiomyopathy, constrictive pericarditis, cor pulmonale or a history of myocarditis (including Chagas disease).
3.A heart transplant or left ventricular assist device or partial left ventricular resection (Batista procedure).
4.Unstable angina pectoris or myocardial infarction within 1 month or a coronary revascularization procedure (coronary artery bypass grafting or percutaneous transluminal angioplasty) within 3 months prior to enrolment.
5.Transient ischemia attack (TIA) or stroke within 3 months prior to enrolment.
6.Any of the following rhythm abnormalities:
a.Second or third degree heart block or sick sinus syndrome (unless treated with a properly functioning pacemaker).
b.History of resuscitated ventricular tachycardia, ventricular fibrillation or sudden death, unless (1) these occurred within 24 hours of an acute myocardial infarction; or (2) the subject has an implanted and properly functioning implantable cardioverter-defibrillator (ICD) which has not fired within 2 months prior to enrolment.
7.Any of the following medications within 2 weeks prior to enrollment: - Oral positive inotropic drugs (except digitalis) or - Lithium salts
8.Any of the following therapies:
a.Intravenous therapy with a positive inotropic agent in an outpatient or short-stay unit within 2 weeks prior to enrollment.
b.Therapy with omapatrilat (when approved for any indication) within 30 days of enrollment or prior history of intolerance to omapatrilat
c.Treatment with an investigational drug within 30 days
d.Participation in any other clinical trial of drug therapy until the present study has been terminated or completed.
9.Participation in an earlier trial with omapatrilat (regardless of treatment received)
10.Concomitant disorders that might compromise the ability to evaluate treatment or enhance the risks of therapy.
11.Any condition or disorder other than heart failure that: Requires ongoing hospitalization for treatment, or - may limit life expectancy within 3 years, or - would not permit optimal participation in the trial, or - would increase the risk of participation to the subject (in the opinion of the investigator)

Study & Design

• Study Type: Interventional
• Study Design: Not specified