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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
42
sacubitril/valsartan (LCZ696) tablet with minimum dose 24/26 mg, maximum dose 97/103 mg twice daily administered orally.
sacubitril/valsartan matching placebo tablet with minimum dose 24/26 mg, maximum dose 97/103 mg twice daily administered orally.
Duke University Medical Center
Durham, North Carolina, United States
Change From Baseline in High-sensitivity Troponin T
An elevated level of troponin T on the high-sensitivity cardiac troponin test indicates heart muscle damage or a heart attack.
Time frame: Baseline, Week 12
Change From Baseline in Soluble ST2
ST2 is a decoy receptor that inhibits beneficial cardioprotective effects of IL-33; such inhibition results in cardiac hypertrophy, myocardial fibrosis, and ventricular dysfunction. Measurement of soluble ST2 has utility for assessing heart failure severity and prognosis.
Time frame: Baseline, Week 12
Change From Baseline in C-reactive Peptide (CRP)
CRP is a pentameric protein synthesized by the liver; its level rises in response to inflammation.
Time frame: Baseline, Week 12
Change From Baseline in P1NP (Procollagen Type I N-propeptide)
Serum P1NP is designated as the reference marker of bone formation in osteoporosis. Elevated markers are associated with increased bone turnover, which increases the deterioration of bone quality and the risk of fragility fracture.
Time frame: Baseline, Week 12
Change From Baseline in Galectin-3
Galectin-3 may be used as a diagnostic or prognostic biomarker for certain types of heart disease, kidney disease and cancer.
Time frame: Baseline, Week 12
Change From Baseline in NT-proBNP (N-terminal Pro B-type Natriuretic Peptide)
Higher levels of NT-proBNP indicate increased heart failure.
Time frame: Baseline, Week 12
Change From Baseline in GDF-15 (Growth/Differentiation Factor-15)
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Highly elevated GDF-15 levels are mostly linked to pathological conditions including inflammation, myocardial ischemia, and notably cancer.
Time frame: Baseline, Week 12
Change From Baseline in IL-6 (Interleukin-6)
IL-6 can be elevated with inflammation, infection, autoimmune disorders, cardiovascular diseases, and some cancers.
Time frame: Baseline, Week 12
Change From Baseline in CITP (C-terminal Telopeptide of Collagen Type I)
Elevated levels of CITP indicate increased bone turnover.
Time frame: Baseline, Week 12
Change From Baseline in Left Ventricular Ejection Fraction (LVEF)
LVEF is the amount of blood pumped out of the heart's left ventricle each time it contracts, represented as a percentage of the blood in the left ventricle that gets pumped out to the body. Normal = LVEF 50% to 70% (midpoint 60%) Mild dysfunction = LVEF 40% to 49% (midpoint 45%) Moderate dysfunction = LVEF 30% to 39% (midpoint 35%) Severe dysfunction = LVEF less than 30%.
Time frame: Baseline, Week 12
Change From Baseline in Focal Fibrosis by Delayed-enhancement on Cardiac MRI
Time frame: Baseline, Week 12
Change From Baseline in Focal Fibrosis by Percentage of Left Ventricular Myocardial Mass on Cardiac MRI
Time frame: Baseline, Week 12
Change From Baseline in EuroQol-5 Dimensions (EQ-5D) Utility Score
The EQ-5D utility score is a value that represents a person's health state based on a set of weights that reflect their preferences. The score is anchored at 0, which represents a state as bad as death, and 1, which represents full health. Negative values can be assigned to health states that are considered worse than death.
Time frame: Baseline, Week 12
Change From Baseline in EuroQOL-5 Dimensions (EQ-5D) Visual Analog Scale (VAS)
The EQ-5D VAS is a scale from 0 (worst imaginable health state) to 100 (best imaginable health state).
Time frame: Baseline, Week 12