Status:
COMPLETED
Protecting With ARNI Against Cardiac Consequences of Coronavirus Disease 2019
Lead Sponsor:
Duke University
Collaborating Sponsors:
Novartis Pharmaceuticals
Conditions:
Covid19
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to determine the effect of sacubitril/valsartan versus placebo on markers of cardiac injury, structure, and function among patients who recovered from acute COVID-19 infec...
Eligibility Criteria
Inclusion
- Patient with a history of laboratory proven-diagnosis of COVID-19 who is 4-16 weeks from their last positive COVID-19 test
- Systolic blood pressure ≥100 mmHg at screening
- ≥18 years of age
- Successful collection of baseline serum biomarkers
- Successful completion of baseline EQ-5D questionnaire
- Successful completion of baseline CMR study (CMR sub-study only)
- High-sensitivity troponin T at or above the level of detection on screening labs
- Presence of ≥1 of the following:
- Age ≥60
- History of atherosclerotic cardiovascular disease (ASCVD), including myocardial infarction, coronary artery disease, ischemic stroke/transient ischemic attack, or peripheral artery disease
- Diabetes mellitus (Type 1 or Type 2)
- Body mass index ≥35 kg/m2
- eGFR 30-60 ml/min/1.73m2
- History of atrial fibrillation/flutter
Exclusion
- Fever within the past 96 hours of \>100.3 degrees Fahrenheit
- Actively receiving therapy with an angiotensin-converting enzyme inhibitor (ACEI), angiotensin II receptor blocker (ARB), aliskiren, or sacubitril/valsartan
- Last known left ventricular ejection fraction of ≤40%
- eGFR \<30 ml/min/1.73m2 on screening labs, including patients on dialysis therapy
- Serum potassium \>5.0 mEq/L on screening labs
- Prior intolerance, allergy or angioedema to ACEI, ARB, or sacubitril/valsartan
- Pregnant or breast-feeding
- In women of childbearing age, unwillingness to use birth control for the duration of the study
- History of heart transplant or durable left ventricular assist device
- Currently implanted permanent pacemaker, defibrillator, or other device that would preclude CMR testing (CMR sub-study only)
- Currently participating in another trial of an investigational medication or device for COVID-19.
- Any other condition that in the judgment of the investigator would jeopardize the patient's compliance with the study protocol
Key Trial Info
Start Date :
August 6 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 13 2023
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT04883528
Start Date
August 6 2021
End Date
June 13 2023
Last Update
July 3 2024
Active Locations (1)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27710