Recruiting PHASE1 Heart Failure

Clinical trial for Heart Failure

Official title Mechanisms of Diuretic Resistance in Heart Failure, Aim 1

ClinicalTrials.gov ID: NCT05323487

What this study is testing

What is Bumetanide Injection?

An investigational injectable loop diuretic being studied as a potential treatment for heart failure. It is designed to increase the excretion of sodium and water by blocking sodium reabsorption in the kidney's loop of Henle.

Also referred to as bumetanide.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
The study aims to learn how and why resistance to loop diuretics develops in heart failure patients.
Who it's for
Adults diagnosed with heart failure who meet the study’s eligibility criteria.
What's involved
Participants will receive several different doses of a loop diuretic in a random order, without knowing which dose they get, and will have repeated measurements taken after each dose.
Time commitment
The study involves multiple visits over several weeks to complete the dose‑response testing.
  • Phase 1: an early, usually small safety study
  • Which group you join is decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join if

  • 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

You likely can't join if

  • 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...
  • History of flash pulmonary edema requiring hospitalization and treatment with biphasic positive airway pressure or mechanical ventilation or a...
  • Hemoglobin \< 8 g/dL
  • Pregnant or breastfeeding
  • Inability to give written informed consent or comply with study protocol or follow-up visits
See the full eligibility criteria
Who can join
  • 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
What rules you out
  • 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...
  • 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...
  • 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

The study team makes the final eligibility decision.

Where it's taking place

  • New Haven, Connecticut, United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include New Haven, Connecticut, United States. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.