Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT05753059

Mechanisms of Diuretic Resistance in Heart Failure, Aim 2

Led by Yale University · Updated on 2025-06-18

50

Participants Needed

1

Research Sites

198 weeks

Total Duration

On this page

Sponsors

Y

Yale University

Lead Sponsor

N

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

Mechanisms of Diuretic Resistance in Heart Failure, Aim 2

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Clinical diagnosis of heart failure
  • No planned changes to heart failure medications or device therapies during the study
  • No unplanned hospitalizations in the past 2 weeks
  • Stable volume status based on symptoms, exam, and dry weight
  • Serum potassium level 5.0 mmol/L or below
  • Serum sodium level 130 mEq/L or above
  • Age over 18 years
  • Hemoglobin level of 8 g/dL or higher
  • Evidence of diuretic resistance to a 10 mg bumetanide challenge with FENa below 10% and total sodium output below 150 mmol plus at least one of the following: chronic home furosemide dose 80 mg or more daily, eGFR below 60 ml/min, serum chloride below 100 mmol/L, or FENa below 5% and total sodium output below 75 mmol on the 2-hour screening
Not Eligible

You will not qualify if you...

  • Glomerular filtration rate below 20 ml/min/1.73m2 or use of renal replacement therapy
  • Use of non-loop diuretics in the last 7 days or 5 half-lives except low dose aldosterone antagonists (spironolactone or eplerenone 50 mg or less)
  • History of flash pulmonary edema needing hospitalization and advanced breathing support or having brittle volume-sensitive heart failure types like infiltrative or restrictive cardiomyopathies
  • Hemoglobin below 8 g/dL or symptomatic anemia
  • Pregnancy or breastfeeding
  • Inability to give informed consent or follow study procedures
  • Chronic urinary retention preventing timed urine collection
  • Current lithium therapy
  • Use of pimozide or thioridazine
  • Diagnosis of liver failure
  • Allergy or contraindication to sulfonamides
  • Allergy or contraindication to thiazide diuretics or bendroflumethiazide

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Yale University

New Haven, Connecticut, United States, 06510

Actively Recruiting

Loading map...

Research Team

V

Veena Rao

CONTACT

K

Kara Otis

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

OTHER

Number of Arms

4

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here