COMPLETED

The Re-Prosper HF Study

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Heart failure with reduced ejection fraction (HFrEF) is a common cause for admission within the Veterans Affairs (VA) Health Care System. It is associated with severe impairment of physical and mental health status and carries a high risk of mortality. Even though significant progress has been made in understanding the disease process, currently, its management and treatment is limited. The investigators have discovered that a commonly used drug for the treatment of gout can be repurposed for the treatment of HFrEF. The objective of this study is the treatment of outpatient Veterans with HFrEF with probenecid to improve heart and health function. Specifically, the investigators are testing whether oral probenecid administered orally twice per day for 180 days improves heart function as measured via ultrasound of the heart (aim 1); improves exercise capacity (aim 2); and improves self-report heart failure specific health status as measured via questionnaires (aim 3).

Official Title

Treatment of Veterans With Heart Failure With Reduced Ejection Fraction With Probenecid

Quick Facts

Study Start:2021-06-09

Study Completion:2025-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT04551222

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Have documented heart failure as a treated inpatient or outpatient diagnosis in the medical record. * Left ventricular ejection 40% within the past 12 months either by echocardiogram, cardiac MRI, cardiac CT, nuclear imaging or cardiac catheterization. * On stable GDMT for at least 2 weeks (including at least an EBM dose of betablocker and RAAS inhibition) consistent with the EPHESUS trial criteria \[16\] or having a documented allergy or adverse reaction to betablocker and/or RAAS inhibition. * Age 18 years or older.	* Acute coronary syndrome or cardiac revascularization within the past 3 months. * End stage renal disease with renal replacement therapy or creatinine clearance less than 30 ml/min \[17\]. * Cardiac resynchronization therapy within the past 3 months. * Constrictive pericarditis or restrictive cardiomyopathy on cardiac imaging study (echocardiogram cardiac MRI, cardiac CT) within the last 12 months. * Ablation for cardiac arrhythmias within the past month. * Peripartum cardiomyopathy diagnosed within past 6 months. If LVEF is still 40% after 6 months of diagnosis, they can be enrolled into the study. * Uncorrected cyanotic congenital heart disease. * Severe right sided valvular disease and/or greater than moderate degree of stenotic or regurgitant left valvular disease. * Terminal illness with expected survival of less than 12 months. * Women who are pregnant, breast feeding, or plan to become pregnant during the study. All women in childbearing age will undergo baseline and quarterly urine pregnancy tests to ensure absence of pregnancy since the cardiometabolic assessments will be different during pregnancy. * Oral therapy with probenecid for any indication during the preceding 3 months. * Hypersensitivity to probenecid based on prior exposure. * Inability to provide informed consent or study procedures due to dementia, unstable psychiatric disease, or other cause (e.g. inability to do perform exercise testing). * Acute gout attack within the previous 3 months. * History of uric acid kidney stones within the last year. Patient will be removed from the study if they develop urate kidney stones. * History of blood diseases in the past year: Aplastic anemia, Hemolytic anemia, Leukopenia, Neutropenia, Pancytopenia, Thrombocytopenia or leukemia. * Creatinine clearance (eGFR) \<30 ml/min.

Inclusion Criteria

Exclusion Criteria

* Have documented heart failure as a treated inpatient or outpatient diagnosis in the medical record.
* Left ventricular ejection 40% within the past 12 months either by echocardiogram, cardiac MRI, cardiac CT, nuclear imaging or cardiac catheterization.
* On stable GDMT for at least 2 weeks (including at least an EBM dose of betablocker and RAAS inhibition) consistent with the EPHESUS trial criteria \[16\] or having a documented allergy or adverse reaction to betablocker and/or RAAS inhibition.
* Age 18 years or older.

* Acute coronary syndrome or cardiac revascularization within the past 3 months.
* End stage renal disease with renal replacement therapy or creatinine clearance less than 30 ml/min \[17\].
* Cardiac resynchronization therapy within the past 3 months.
* Constrictive pericarditis or restrictive cardiomyopathy on cardiac imaging study (echocardiogram cardiac MRI, cardiac CT) within the last 12 months.
* Ablation for cardiac arrhythmias within the past month.
* Peripartum cardiomyopathy diagnosed within past 6 months. If LVEF is still 40% after 6 months of diagnosis, they can be enrolled into the study.
* Uncorrected cyanotic congenital heart disease.
* Severe right sided valvular disease and/or greater than moderate degree of stenotic or regurgitant left valvular disease.
* Terminal illness with expected survival of less than 12 months.
* Women who are pregnant, breast feeding, or plan to become pregnant during the study. All women in childbearing age will undergo baseline and quarterly urine pregnancy tests to ensure absence of pregnancy since the cardiometabolic assessments will be different during pregnancy.
* Oral therapy with probenecid for any indication during the preceding 3 months.
* Hypersensitivity to probenecid based on prior exposure.
* Inability to provide informed consent or study procedures due to dementia, unstable psychiatric disease, or other cause (e.g. inability to do perform exercise testing).
* Acute gout attack within the previous 3 months.
* History of uric acid kidney stones within the last year. Patient will be removed from the study if they develop urate kidney stones.
* History of blood diseases in the past year: Aplastic anemia, Hemolytic anemia, Leukopenia, Neutropenia, Pancytopenia, Thrombocytopenia or leukemia.
* Creatinine clearance (eGFR) \<30 ml/min.

Contacts and Locations

Principal Investigator

Jack Rubinstein, MD

PRINCIPAL_INVESTIGATOR

Cincinnati VA Medical Center, Cincinnati, OH

Study Locations (Sites)

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Boston, Massachusetts, 02130-4817

United States

Cincinnati VA Medical Center, Cincinnati, OH

Cincinnati, Ohio, 45220-2213

United States

Louis Stokes VA Medical Center, Cleveland, OH

Cleveland, Ohio, 44106-1702

United States

Providence VA Medical Center, Providence, RI

Providence, Rhode Island, 02908-4734

United States

Hunter Holmes McGuire VA Medical Center, Richmond, VA

Richmond, Virginia, 23249-0001

United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

Jack Rubinstein, MD, PRINCIPAL_INVESTIGATOR, Cincinnati VA Medical Center, Cincinnati, OH

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-06-09

Study Completion Date2025-12-31

Study Record Updates

Study Start Date2021-06-09

Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

heart failure
probenecid

Additional Relevant MeSH Terms

Heart Failure