Understanding Diuretic Resistance in Heart Failure
Mechanisms of Diuretic Resistance in Heart Failure
This study is testing how different doses of a diuretic medication can help heart failure patients get rid of excess fluid and understand why some people don’t respond well to these treatments.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Yale University Academic / other |
| Locations | 1 site (New Haven, Connecticut) |
| Trial ID | NCT05323487 on ClinicalTrials.gov |
What this trial studies
This study investigates the mechanisms behind diuretic resistance in heart failure patients by employing a randomized, double-blind design. It will involve 75 participants who will receive varying doses of bumetanide, a loop diuretic, to assess their sodium excretion response. The study aims to standardize dietary sodium intake to minimize variability in diuretic response. Participants will undergo multiple assessments over a series of visits to determine their individual responses to the medication.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with a clinical diagnosis of heart failure who are stable and not undergoing changes in their heart failure treatment.
Not a fit: Patients with severely reduced kidney function or those using certain diuretics may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for heart failure patients experiencing diuretic resistance.
How similar studies have performed: Other studies have explored diuretic responses in heart failure, but this specific approach to understanding diuretic resistance is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Clinical diagnosis of HF * No plan for titration/change of heart failure medical or device therapies during the study period. * Absence of non-elective hospitalizations in the previous 3 months. * At optimal volume status by symptoms, exam, and dry weight * Age \> 18 years Exclusion Criteria: * GFR \<20 ml/min/1.73m2 using the Chronic Kidney Disease- Epidemiology (CKD-EPI)equation or use of renal replacement therapies * Use of any non-loop type diuretic in the last 14 days with the exclusion of low dose aldosterone antagonist (e.g., spironolactone or eplerenone ≤50 mg). Examples of non-loop diuretics include but may not be limited to acetazolamide (oral or IV, not ophthalmic), metolazone, Hydrochlorothiazide (HCTZ), chlorthalidone, chlorothiazide, indapamide, triamterene, amiloride, finerenone, spironolactone dose \> 50mg day, eplerenone \> 50mg/day, * History of flash pulmonary edema requiring hospitalization and treatment with biphasic positive airway pressure or mechanical ventilation or a "brittle" volume sensitive HF phenotype such as an infiltrative or restrictive cardiomyopathy (i.e. amyloid cardiomyopathy, etc). * Hemoglobin \< 8 g/dL * Pregnant or breastfeeding * Inability to give written informed consent or comply with study protocol or follow-up visits * Chronic Urinary retention limiting ability to perform timed urine collection procedures
Where this trial is running
New Haven, Connecticut
- Yale University — New Haven, Connecticut, United States (Recruiting)
Study contacts
- Principal investigator: Jeffrey Testani — Yale University
- Study coordinator: Veena Rao
- Email: veena.s.rao@yale.edu
- Phone: 2037373571
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.