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Angiotensin Receptor-Neprilysin Inhibitor
Sacubitril-Valsartan for Heart Failure (TREAT-HF Trial)
Phase 1 & 2
Recruiting
Led By Wendy Bottinor, MD
Research Sponsored by Virginia Commonwealth University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Previous anthracycline chemotherapy
No symptoms of heart failure (shortness of breath, fatigue, swelling). Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 27 months
Awards & highlights
TREAT-HF Trial Summary
This trial is testing a new heart failure medication in young adult cancer survivors.
Who is the study for?
Adult cancer survivors diagnosed before age 39 with stage B heart failure can join this trial. They must have had anthracycline chemo, reduced heart function but no symptoms of heart failure, and be able to perform physical activity without severe fatigue or breathlessness. Excluded are those with chronic high potassium levels, recent COVID-19 contact, certain valve issues or severe kidney disease, pregnant women, non-English/Spanish speakers who can't consent properly, and people on conflicting medications.Check my eligibility
What is being tested?
The study is testing the effects of sacubitril-valsartan versus valsartan alone in treating heart dysfunction caused by cancer therapy. It aims to see if recruiting adult cancer survivors for this treatment is possible and how well they tolerate it.See study design
What are the potential side effects?
Possible side effects include changes in blood pressure, kidney function problems, high potassium levels which could affect the heartbeat rhythm (hyperkalemia), dizziness due to low blood pressure (hypotension), coughing and swelling around the eyes.
TREAT-HF Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have received anthracycline chemotherapy before.
Select...
I do not experience heart failure symptoms like shortness of breath or swelling.
Select...
I was diagnosed with cancer at 39 years old or younger.
Select...
My heart's pumping ability is reduced but still above 40%.
TREAT-HF Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 27 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~27 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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.
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.
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.
Secondary outcome measures
Evaluate early efficacy of sacubitril-valsartan in the treatment of stage B heart failure among survivors of cancer diagnosed at or before age 39.
TREAT-HF Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm 2: ValsartanExperimental Treatment1 Intervention
Valsartan administered orally twice daily at a maximally tolerate dose (max dose 160mg twice daily)
Group II: Arm 1: Sacubitril-valsartanExperimental Treatment1 Intervention
Sacubitril-valsartan administered orally twice daily at a maximally tolerate dose (max dose 97mg/103mg twice daily).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Valsartan
2016
Completed Phase 4
~10560
Find a Location
Who is running the clinical trial?
Virginia Commonwealth UniversityLead Sponsor
700 Previous Clinical Trials
22,887,015 Total Patients Enrolled
23 Trials studying Heart Failure
4,745 Patients Enrolled for Heart Failure
Wendy Bottinor, MDPrincipal InvestigatorVirginia Commonwealth University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My family has a history of genetic heart muscle disease.I am not taking, or can stop taking, ACE inhibitors, ARBs, NSAIDs, aliskiren, or lithium for the study.I have severe kidney disease.I was diagnosed with constrictive cardiomyopathy before starting cancer treatment.I cannot measure my blood pressure or heart rate at home.You have had serious allergic reactions to gadolinium-based contrast agents.I have heart disease that affects my daily activities.There are signs of a specific heart condition called infiltrative cardiomyopathy.I have received anthracycline chemotherapy before.My medical records clearly show my diagnosis and treatment plan.I cannot complete a heart MRI or a 6-minute walk test.I do not experience heart failure symptoms like shortness of breath or swelling.I was diagnosed with cancer at 39 years old or younger.My heart's pumping ability is reduced but still above 40%.I have not been in another study or taken experimental drugs recently.I had significant heart valve issues before starting cancer treatment.You are allergic to valsartan or sacubitril.You have consistently high levels of potassium in your blood.I have had COVID-19 or been exposed to it recently.I am under 18 years old.I had heart valve issues before starting cancer treatment.You have a serious heart problem, as determined by the doctor, except for small holes in the heart.You have a serious buildup of fluid around your heart.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 1: Sacubitril-valsartan
- Group 2: Arm 2: Valsartan
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment still available for participants of this research?
"According to clinicaltrials.gov, this research endeavour is actively signing up participants; it was originally posted on March 9th 2022 and recently updated on May 6th 2022."
Answered by AI
In what medical conditions is Sacubitril-valsartan most commonly prescribed?
"Sacubitril-valsartan is typically prescribed to treat certain types of ventricular dysfunction, as well as essential hypertension that cannot be successfully managed using a single therapy. It can also serve prophylactically against cardiovascular events."
Answered by AI
Is participation in this medical study open to those under the age of 25?
"To be eligible for this research, potential participants must fall between the age of 18 and 120. Concomitantly, 23 clinical trials are available to those under 18 years old, while 720 studies can accomodate individuals over 65."
Answered by AI
What is the current participation rate of this research project?
"Indeed, according to the clinicaltrials.gov website, this medical trial is still in need of volunteers. It was first advertised on March 9th 2022 and has been recently updated as of May 6th 2022. The study requires 30 individuals from one location."
Answered by AI
What criteria must be fulfilled to join this medical research trial?
"The requirements for admission into this heart failure trial necessitate that patients are between 18 and 120 years old. The investigators hope to admit a total of 30 individuals."
Answered by AI
Have researchers conducted any prior research into the efficacy of Sacubitril-valsartan?
"At present, there are 37 studies being conducted pertaining to Sacubitril-valsartan. Of those active clinical trials, 8 have reached phase 3 status. While a majority of these investigations can be found in Montreal, Quebec, global participation serves as a testament to the reach and efficacy of this medication with 826 sites running related experiments."
Answered by AI
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