NCT05323487RecruitingPhase 1
Mechanisms of Diuretic Resistance in Heart Failure, Aim 1
Mechanisms of Diuretic Resistance in Heart Failure
Source: ClinicalTrials.gov · Last updated 22 May 2026
Brief summary (registry, in English)
This study will employ a randomized order, double-blind, repeated measures dose ranging design. This design was chosen in order to generate multiple within-subject serial loop diuretic dose response exposures. The overall study schema will include 75 heart failure (HF) patients.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 75 (estimated)
- First submitted
- 4 Apr 2022
- Start date
- 1 Jun 2022
- Primary completion date
- 1 May 2027
- Lead sponsor
- Yale University
- Diseases
- Heart failure
- NCT number
- NCT05323487
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 75
- From 1 Jun 2022 to the primary completion date, 1 May 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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).
Lab values
- GFR \<20 ml/min/1.73m2 using the Chronic Kidney Disease- Epidemiology (CKD-EPI)equation or use of renal replacement therapies
- Hemoglobin \< 8 g/dL
Other
- 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,
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Yale University Coordinator of this site? Confirm its status | New Haven | United States | Recruiting |
Related publications
- Assessment of Ototoxicity in Patients With Heart Failure Receiving High-Dose IV Loop Diuretics.JAMA Cardiol · 2026 · PMID 42961411
This page is information, not medical advice. Discuss any trial with your doctor.