To determine feasibility of recruitment and tolerability of treatment with sacubitril-valsartan among adult age survivors of cancer diagnosed at or before age 39 who have stage B heart failure.
The current study will test the hypothesis that among adult age survivors of cancer diagnosed at age \< 39 years treatment of Stage B heart failure with sacubitril-valsartan is feasible and safe.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
53
Administered orally twice daily at a maximally tolerate dose (max dose 97mg/103mg twice daily).
Administered orally twice daily at a maximally tolerate dose (max dose 160mg twice daily)
Virginia Commonwealth University
Richmond, Virginia, United States
RECRUITINGDetermine feasibility of recruitment to this pilot trial by evaluating the eligibility requirements among adult age survivors of cancer diagnosed at or before age 39 who have stage B heart failure.
Number of participants screened for the clinical trial.
Time frame: 24 Months
Determine the feasibility of recruitment to this pilot trial by evaluating the eligibility requirements among adult age survivors of cancer diagnosed at or before age 39 who have stage B heart failure.
Number of participants enrolled on the trial
Time frame: 27 Months
Determine tolerability of treatment with sacubitril-valsartan among adult age survivors of cancer diagnosed at or before age 39 who have stage B heart failure.
Number of participants that complete therapy
Time frame: 27 Months
Evaluate early efficacy of sacubitril-valsartan in the treatment of stage B heart failure among survivors of cancer diagnosed at or before age 39.
Number of deaths while on study due to cardiac event
Time frame: 27 Months
Evaluate early efficacy of sacubitril-valsartan in the treatment of stage B heart failure among survivors of cancer diagnosed at or before age 39.
Number of deaths while on study due to non-cardiac events
Time frame: 90 Days
Evaluate early efficacy of sacubitril-valsartan in the treatment of stage B heart failure among survivors of cancer diagnosed at or before age 39.
By the number of Adverse events at 30 days
Time frame: 30 Days
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Evaluate early efficacy of sacubitril-valsartan in the treatment of stage B heart failure among survivors of cancer diagnosed at or before age 39.
By the number of Adverse events at 60 days
Time frame: 60 Days
Evaluate early efficacy of sacubitril-valsartan in the treatment of stage B heart failure among survivors of cancer diagnosed at or before age 39.
By the number of Adverse events at 90 days
Time frame: 90 Days
Evaluate early efficacy of sacubitril-valsartan in the treatment of stage B heart failure among survivors of cancer diagnosed at or before age 39.
By determining number of participants with interval change utilizing a 6-minute walk test distance
Time frame: 90 Days
Evaluate early efficacy of sacubitril-valsartan in the treatment of stage B heart failure among survivors of cancer diagnosed at or before age 39.
By number of participants with cardiovascular magnetic resonance imaging assessment change in cardiac fibrosis burden.
Time frame: 90 Days
Evaluate early efficacy of sacubitril-valsartan in the treatment of stage B heart failure among survivors of cancer diagnosed at or before age 39.
By number of participants with cardiovascular magnetic resonance imaging assessment change in microvascular perfusion.
Time frame: 90 Days
Evaluate early efficacy of sacubitril-valsartan in the treatment of stage B heart failure among survivors of cancer diagnosed at or before age 39.
By number of participants with cardiovascular magnetic resonance imaging assessment change in arterial stiffness/4D flow.
Time frame: 90 Days
Evaluate early efficacy of sacubitril-valsartan in the treatment of stage B heart failure among survivors of cancer diagnosed at or before age 39.
By number of participants with cardiovascular magnetic resonance imaging assessment change in left ventricular ejection fraction.
Time frame: 90 Days
Evaluate early efficacy of sacubitril-valsartan in the treatment of stage B heart failure among survivors of cancer diagnosed at or before age 39.
By number of participants with cardiovascular magnetic resonance imaging assessment change in change in left ventricular strain.
Time frame: 90 Days