Heart FailurePhase 1/2TREAT-HFNCT05194111
Treating Heart Dysfunction Related to Cancer Therapy With Sacubitril/Valsartan
A Phase 1/2 study testing Sacubitril-valsartan, Valsartan and Carvedilol in people with Heart Failure and Heart Dysfunction, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Heart Failure, Heart Dysfunction
- What is being tested?
- Sacubitril-valsartan, Valsartan and Carvedilol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Aug 2022to 30 Nov 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age </= 39 years old at time of cancer diagnosis
- Clinical records adequate to determine diagnosis and treatment regimen
- Previous anthracycline chemotherapy
- Global longitudinal strain <18% and/or
- Left ventricular ejection fraction (LVEF) below the institutional lower limit of normal but >/=40% on echocardiogram or cardiac magnetic resonance imaging (MRI)
- No symptoms of heart failure (shortness of breath, fatigue, swelling). Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath).
Who cannot join
- -Age <18 years
- Inability to obtain consent from patient or legally authorized representative
- Active acute or chronic psychiatric illness that in the opinion of the investigator may prevent compliance with study instructions
- Limited English or Spanish proficiency that in the opinion of the investigator may prevent understanding the content of the informed consent form or safely completing the study procedures
- Participation in another concurrent intervention study within 30 days or treatment with an investigational drug within 5 half-lives prior to randomization
- Greater than mild mitral or aortic valve regurgitation/stenosis known pre-cancer therapy
Show all 22Show fewer
- Severe kidney disease (glomerular filtration rate (GFR) <30 milliliters (mL)/minute (min)/1.73 meters squared (m2))
- Chronic hyperkalemia (>5millimoles per liter (mmol/L))
- Evidence of Coronavirus (COVID-19) within the last 60 days or recent (21 days) exposure to close personal contact with COVID-19.
- Greater than moderate tricuspid or pulmonary valve regurgitation/stenosis known pre-cancer therapy
- Hemodynamically significant congenital heart disease in the opinion of the investigator (not including patent foramen ovale (PFO)/small atrial septal defect (ASD) or small ventricular septal defect (VSD))
- Greater than moderate pericardial effusion
- Constrictive cardiomyopathy diagnosed pre-cancer therapy
- Family history of genetic cardiomyopathy
- Evidence of infiltrative cardiomyopathy
- Symptomatic heart disease based on New York Heart Association (NYHA) classification
- Allergy to valsartan or sacubitril
- Inability to complete cardiac magnetic resonance (CMR) or 6-minute walk test
- Inability to measure non-invasive blood pressure and heart rate in the ambulatory/home setting
- Pregnant/lactating
- History of severe hypersensitivity reactions to gadolinium-based contrast agents (will perform limited cardiac imaging without contrast)
- Concomitant use of other angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARBs), aliskiren, non-steroidal anti-inflammatories (NSAIDs) or lithium or the inability to stop these medications for the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Virginia Commonwealth University
Richmond, Virginia, 23298
Massey CTO CPC Team, 804-628-6430, masseycpc@vcu.edu
Wendy Bottinor, MD
About this study
Official title: Treating Heart Dysfunction Related to Cancer Therapy With Sacubitril/Valsartan (Treat HF)
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.
Read the detailed description
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.
- Conditions
- Heart Failure, Heart Dysfunction
- Being tested
- Sacubitril-valsartan, Valsartan, Carvedilol
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacubitril-valsartanDrug
Administered orally twice daily at a maximally tolerate dose (max dose 97mg/103mg twice daily).
ValsartanDrug
Administered orally twice daily at a maximally tolerate dose (max dose 160mg twice daily)
CarvedilolDrug
Administered orally twice daily at a maximally tolerated dose (max dose 25mg twice daily)
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Sacubitril-valsartan | Experimental | Sacubitril-valsartan administered orally twice daily at a maximally tolerate dose (max dose 97mg/103mg twice daily). Receives: Drug: Sacubitril-valsartan |
| Arm 2: Valsartan | Experimental | Valsartan administered orally twice daily at a maximally tolerate dose (max dose 160mg twice daily) Receives: Drug: Valsartan |
| Arm 3: Carvedilol | Experimental | Administered orally twice daily at a maximally tolerated dose (max dose 25mg twice daily) Receives: Drug: Carvedilol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 27 Months
Secondary outcomes (14)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 90 Days, 365 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2022
- Study start11 Aug 2022
- Primary completion30 Nov 2028 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wendy Bottinor, MD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05194111
- Sponsor's protocol ID
- MCC-21-18830
- Other IDs
- HM20023601
- Acronym
- TREAT-HF
- Status last verified
- Jul 2026
- First submitted
- 3 Jan 2022
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: There are no plans to make individual participant data available to other researchers at this time.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Heart Dysfunction Related to Cancer Therapy With Sacubitril/Valsartan (Treat HF)
- ClinicalTrials.gov ID
- NCT05194111
- Acronym / sponsor ID
- TREAT-HF / MCC-21-18830
- Conditions
- Heart Failure, Heart Dysfunction
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 11 Aug 2022 (actual)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 18 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Sacubitril-valsartan | Experimental | Drug: Sacubitril-valsartanSacubitril-valsartan administered orally twice daily at a maximally tolerate dose (max dose 97mg/103mg twice daily). |
| Arm 2: Valsartan | Experimental | Drug: ValsartanValsartan administered orally twice daily at a maximally tolerate dose (max dose 160mg twice daily) |
| Arm 3: Carvedilol | Experimental | Drug: CarvedilolAdministered orally twice daily at a maximally tolerated dose (max dose 25mg twice daily) |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age </= 39 years old at time of cancer diagnosis
- Clinical records adequate to determine diagnosis and treatment regimen
- Previous anthracycline chemotherapy
- Global longitudinal strain <18% and/or
- Left ventricular ejection fraction (LVEF) below the institutional lower limit of normal but >/=40% on echocardiogram or cardiac magnetic resonance imaging (MRI)
Key exclusion criteria (22 listed)
- -Age <18 years
- Inability to obtain consent from patient or legally authorized representative
- Active acute or chronic psychiatric illness that in the opinion of the investigator may prevent compliance with study instructions
- Limited English or Spanish proficiency that in the opinion of the investigator may prevent understanding the content of the informed consent form or safely completing the study procedures
- Participation in another concurrent intervention study within 30 days or treatment with an investigational drug within 5 half-lives prior to randomization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sacubitril-valsartanAdministered orally twice daily at a maximally tolerate dose (max dose 97mg/103mg twice daily). | Drug | Arm 1: Sacubitril-valsartan |
| ValsartanAdministered orally twice daily at a maximally tolerate dose (max dose 160mg twice daily) | Drug | Arm 2: Valsartan |
| CarvedilolAdministered orally twice daily at a maximally tolerated dose (max dose 25mg twice daily) | Drug | Arm 3: Carvedilol |
Primary outcome
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.
Time frame: 24 Months
Number of participants screened for the clinical trial.
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.
Time frame: 27 Months
Number of participants enrolled on the trial
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.
Time frame: 27 Months
Number of participants that complete therapy
14 secondary outcomes
Evaluate early efficacy of sacubitril-valsartan in the treatment of stage B heart failure among survivors of cancer diagnosed at or before age 39.
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.
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.
Time frame: 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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 90 Days, 365 Days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Individual participant dataSharing planned: No. There are no plans to make individual participant data available to other researchers at this time.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wendy Bottinor, MD principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Sacubitril-valsartan, Valsartan and Carvedilol in people with Heart Failure and Heart Dysfunction, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Massey CTO CPC Team (804-628-6430, masseycpc@vcu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 24 Months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.