Phase 2
N=42
Protecting With ARNI Against Cardiac Consequences of Coronavirus Disease 2019
Covid19
Bottom Line
View on ClinicalTrials.gov: NCT04883528 ↗Enrolled (actual)
42
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcome: Primary: Change From Baseline in High-sensitivity Troponin T — 1.12; 1.01 ng/mL — p=0.29
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Sacubitril / Valsartan Oral Tablet [Entresto] (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Jun 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in High-sensitivity Troponin T |
1.12; 1.01 | 0.29 |
| PRIMARY Change From Baseline in Soluble ST2 |
0.95; 0.96 | 0.88 |
| SECONDARY Change From Baseline in C-reactive Peptide (CRP) |
0.94; 0.87 | 0.76 |
| SECONDARY Change From Baseline in P1NP (Procollagen Type I N-propeptide) |
0.98; 0.99 | 0.85 |
| SECONDARY Change From Baseline in Galectin-3 |
0.89; 0.91 | 0.80 |
| SECONDARY Change From Baseline in NT-proBNP (N-terminal Pro B-type Natriuretic Peptide) |
0.60; 1.11 | 0.01 sig |
| SECONDARY Change From Baseline in GDF-15 (Growth/Differentiation Factor-15) |
1.14; 1.00 | 0.23 |
| SECONDARY Change From Baseline in IL-6 (Interleukin-6) |
1.10; 1.07 | 0.95 |
| SECONDARY Change From Baseline in CITP (C-terminal Telopeptide of Collagen Type I) |
0.77; 1.55 | 0.03 sig |
| SECONDARY Change From Baseline in Left Ventricular Ejection Fraction (LVEF) |
0.5; 0.5 | — |
| SECONDARY Change From Baseline in Focal Fibrosis by Delayed-enhancement on Cardiac MRI |
— | — |
| SECONDARY Change From Baseline in Focal Fibrosis by Percentage of Left Ventricular Myocardial Mass on Cardiac MRI |
— | — |
| SECONDARY Change From Baseline in EuroQol-5 Dimensions (EQ-5D) Utility Score |
0.01; 0.03 | 0.64 |
| SECONDARY Change From Baseline in EuroQOL-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) |
-5.60; 1.95 | 0.04 sig |
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.
Eligibility Criteria
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:
- 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 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 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
Data sourced from ClinicalTrials.gov (NCT04883528). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.