Actively Recruiting

Phase 4
Age: 18Years - 65Years
All Genders
ID06414759

Efficacy and Safety of Combination Diuretic Therapy in Patients With Acute Decompensated Heart Failure and Volume Overload

Led by Cairo University · Updated on 2024-07-24

110

Participants Needed

1

Research Sites

12 weeks

Total Duration

On this page

Sponsors

C

Cairo University

Lead Sponsor

N

National Heart Institute, Egypt

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and effectiveness of two medications, acetazolamide and metolazone, in combination with loop diuretics for patients with acute decompensated heart failure (ADHF) who have volume overload. The goal is to determine which combination helps reduce fluid buildup better and is safer for these patients, aiding doctors in selecting the best treatment. This is a Phase 4 randomized study that compares these treatments directly. Participants are assigned to one of two groups. The first group receives intravenous (IV) loop diuretics at twice their usual oral dose along with oral acetazolamide once daily, stopping their usual oral diuretics. The second group receives IV loop diuretics at the same dosing schedule plus oral metolazone once daily, also stopping oral diuretics. If patients were not on oral diuretics before, a starting dose of IV furosemide, bumetanide, or torsemide is used. Treatments are given during hospitalization. During the study, patients will be monitored for urine output over 48 hours as the primary outcome. Secondary outcomes include response to diuretics, body weight, congestion signs, blood markers like NT-proBNP, kidney function tests, electrolytes, blood pressure, hospital stay length, and heart failure events over three months. Safety and effectiveness data are collected through tests and observations during and after treatment, with the study expected to last until March 2025.

CONDITIONS

Brief Title

Efficacy and Safety of Combination Diuretic Therapy in Patients With Acute Decompensated Heart Failure and Volume Overload

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female patients aged 18 years or older and younger than 65 years.
  • Clinical diagnosis of acute decompensated heart failure with at least one sign of volume overload such as edema (score 2 or higher), ascites confirmed by echography, pleural effusion confirmed by chest X-ray or echography, rales on auscultation, or jugular venous pressure greater than 10 mm Hg.
Not Eligible

You will not qualify if you...

  • Acute kidney injury at hospital admission, defined by specific increases in serum creatinine or low urine volume.
  • Acute pulmonary edema due to increased afterload without significant fluid accumulation.
  • Expected exposure to nephrotoxic agents during hospitalization.
  • Anuria or current renal replacement therapy or ultrafiltration.
  • Estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73m² at screening.
  • Expected use of intravenous inotropes, vasopressors, or nitroprusside during the study.
  • Prior cardiac transplantation or use of a ventricular assist device.
  • Blood pressure below 90 mmHg systolic or mean arterial pressure below 65 mmHg at recruitment.
  • Pregnancy or breastfeeding.
  • Use of acetazolamide or metolazone within one month before randomization.
  • Use of diuretics during treatment phase not specified in the protocol, except mineralocorticoid receptor antagonists.

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 48 hours

Participants receive combination diuretic therapy with IV loop diuretics plus either oral acetazolamide or oral metolazone to manage acute decompensated heart failure and volume overload.

Up to 2 days of hospital visits

Follow-up

Duration - Up to 3 months

Participants are monitored for outcomes including length of hospital stay and mortality or heart failure events.

Follow-up visits as needed up to 3 months

Trial Site Locations

Total: 1 location

1

National Heart Institute

Giza, GZ, Egypt, 3755204

Actively Recruiting

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Research Team

M

Mohamed AN Abdelmoaty, B.Sc. Pharmaceutical Sciences

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Prevalence, predictors and clinical outcome of residual congestion in acute decompensated heart failure.

Jorge Rubio-Gracia, Biniyam G Demissei, Jozine M Ter Maaten...

https://pubmed.ncbi.nlm.nih.gov/29544928