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| ID | Type | Description | Link |
|---|---|---|---|
| HM20023601 | Other Identifier | Virginia Commonwealth University |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Sacubitril-valsartan | Experimental | Sacubitril-valsartan administered orally twice daily at a maximally tolerate dose (max dose 97mg/103mg twice daily). |
|
| Arm 2: Valsartan | Experimental | Valsartan administered orally twice daily at a maximally tolerate dose (max dose 160mg twice daily) |
|
| Arm 3: Carvedilol | Experimental | Administered orally twice daily at a maximally tolerated dose (max dose 25mg twice daily) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sacubitril-valsartan | Drug | Administered orally twice daily at a maximally tolerate dose (max dose 97mg/103mg twice daily). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Determine 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. | 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 | 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 | 27 Months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Massey CTO CPC Team | Contact | 804-628-6430 | masseycpc@vcu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Wendy Bottinor, MD | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Commonwealth University | Recruiting | Richmond | Virginia | 23298 | United States |
There are no plans to make individual participant data available to other researchers at this time.
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C549068 | sacubitril and valsartan sodium hydrate drug combination |
| D000068756 | Valsartan |
| D000077261 | Carvedilol |
| ID | Term |
|---|---|
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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Cardiac magnetic resonance studies will be de-identified and assigned a study number. The identification key will not be available to cardiac magnetic resonance readers so that they are blinded to treatment allocation
| Valsartan | Drug | Administered orally twice daily at a maximally tolerate dose (max dose 160mg twice daily) |
|
| Carvedilol | Drug | Administered orally twice daily at a maximally tolerated dose (max dose 25mg twice daily) |
|
Number of deaths while on study due to non-cardiac events |
| 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 | 30 Days after start of treatment |
| 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 | 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 determining number of participants with interval change utilizing a 6-minute walk test distance | 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 180 days | 180 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 270 days | 270 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 365 days | 365 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 | Baseline, Day 60 days, 365 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. | Baseline, 90 Days, 365 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. | Baseline, 90 Days, 365 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. | Baseline, 90 Days, 365 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. | Baseline, 90 Days, 365 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. | Baseline, 90 Days, 365 Days |
| D014633 |
| Valine |
| D000597 | Amino Acids, Branched-Chain |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000601 | Amino Acids, Essential |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D002227 | Carbazoles |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |