CompletedPhase 1/2

Protecting With ARNI Against Cardiac Consequences of Coronavirus Disease 2019

United States42 participantsStarted 2021-08-06

Plain-language 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 infection.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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:

Exclusion criteria

✕. 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

What they're measuring

Change From Baseline in High-sensitivity Troponin T

Timeframe: Baseline, Week 12

Change From Baseline in Soluble ST2

Timeframe: Baseline, Week 12

Trial details

NCT IDNCT04883528

SponsorDuke University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-06-13

Results submitted2024-06-06

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