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RecruitingPhase 1

Mechanisms of Diuretic Resistance in Heart Failure, Aim 1

Mechanisms of Diuretic Resistance in Heart Failure

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Infusions

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The protocol will begin with pre-study determination of diuretic response at the screening visit via administration of 10 mg IV bumetanide infused over 1 hour and measuring peak Fractional Excretion of Sodium (FENa), 1-hour post completion of infusion."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how people with heart failure respond to different doses of loop diuretics, a type of water pill that helps remove extra fluid. It will include 75 adults with heart failure whose treatment and fluid levels are stable.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have a diagnosis of heart failure.
  • Be older than 18.
  • Have no planned changes to heart failure medicines or device treatments during the study.
  • Have had no unplanned hospital stays in the past 3 months.
  • Be at your best fluid level, based on symptoms, an exam, and your weight without extra fluid.

Who can't join

  • Have a kidney filtering rate (GFR) below 20, or use dialysis or another treatment that replaces kidney function.
  • Have used a water pill other than a loop diuretic in the past 14 days. Spironolactone or eplerenone at 50 mg a day or less is allowed. Acetazolamide eye drops do not count.
  • Have had sudden fluid buildup in the lungs that needed a hospital stay and breathing support, or have heart failure that is very sensitive to fluid changes, such as certain diseases that stiffen the heart.
  • Have hemoglobin below 8 g/dL. Hemoglobin is the protein in red blood cells that carries oxygen.
  • Are pregnant or breastfeeding.
  • Cannot give written consent or follow study instructions and attend follow-up visits.
  • Have ongoing trouble emptying your bladder that limits your ability to collect urine at set times.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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

Study sites (1)

CT