RECRUITING

Mechanisms of Diuretic Resistance in Heart Failure, Aim 2

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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

Randomized placebo-controlled, double-blind, double-dummy, crossover design testing combinations placebo/placebo, bendroflumethiazide/placebo, amiloride/placebo, and bendroflumethiazide/amiloride added to bumetanide.

Official Title

Mechanisms of Diuretic Resistance in Heart Failure, Aim 2

Quick Facts

Study Start:2023-08-10

Study Completion:2027-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05753059

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
1. Chronic clinical diagnosis of HF with a documented ejection fraction \<40%. 2. Use of beta blocker, ACE, ARB or neprilysin inhibitor (sacubitril/valsartan), aldosterone antagonist, and SGLT2 inhibitor at ≥50% guideline directed doses for 30 days with no plan for titration/change during the study period. 3. Chronic stable use of ≥80mg furosemide equivalents per day for ≥ 30 days 4. Peak FENa \< 5% following 10mg IV bumetanide challenge at the screening visit 5. Absence of hospitalizations in the previous 3 months. 6. At optimal volume status by symptoms, exam, and dry weight. 7. Serum potassium ≤ 5.0 mmol/L 8. Serum sodium ≥ 130 mEq/L 9. Age \> 18 years	1. GFR \<20 ml/min/1.73m2 2. Use of any non-loop type diuretic in the last 14 days with the exclusion of low dose aldosterone antagonist (e.g., spironolactone ≤50 mg) 3. History of flash pulmonary edema or a "brittle" volume sensitive HF phenotype such as amyloid cardiomyopathy 4. Hemoglobin \< 8 g/dL 5. Pregnant or breastfeeding 6. Inability to give written informed consent or comply with study protocol or follow-up visits

Inclusion Criteria

Exclusion Criteria

1. Chronic clinical diagnosis of HF with a documented ejection fraction \<40%.
2. Use of beta blocker, ACE, ARB or neprilysin inhibitor (sacubitril/valsartan), aldosterone antagonist, and SGLT2 inhibitor at ≥50% guideline directed doses for 30 days with no plan for titration/change during the study period.
3. Chronic stable use of ≥80mg furosemide equivalents per day for ≥ 30 days
4. Peak FENa \< 5% following 10mg IV bumetanide challenge at the screening visit
5. Absence of hospitalizations in the previous 3 months.
6. At optimal volume status by symptoms, exam, and dry weight.
7. Serum potassium ≤ 5.0 mmol/L
8. Serum sodium ≥ 130 mEq/L
9. Age \> 18 years

1. GFR \<20 ml/min/1.73m2
2. Use of any non-loop type diuretic in the last 14 days with the exclusion of low dose aldosterone antagonist (e.g., spironolactone ≤50 mg)
3. History of flash pulmonary edema or a "brittle" volume sensitive HF phenotype such as amyloid cardiomyopathy
4. Hemoglobin \< 8 g/dL
5. Pregnant or breastfeeding
6. Inability to give written informed consent or comply with study protocol or follow-up visits

Contacts and Locations

Study Contact

Veena Rao

CONTACT

203-737-3571

veena.s.rao@yale.edu

Kara Otis

CONTACT

203-737-3571

kara.otis@yale.edu

Principal Investigator

Jeffrey Testani

PRINCIPAL_INVESTIGATOR

Yale University

Study Locations (Sites)

Yale University

New Haven, Connecticut, 06510

United States

Collaborators and Investigators

Sponsor: Yale University

Jeffrey Testani, PRINCIPAL_INVESTIGATOR, Yale University

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 Date2023-08-10

Study Completion Date2027-06

Study Record Updates

Study Start Date2023-08-10

Study Completion Date2027-06

Terms related to this study

Additional Relevant MeSH Terms

Heart Failure