Overview

The Heart Failure Diuresis Efficacy Comparison (DEA-HF) Study

Status:
Recruiting

Trial end date:
2023-08-24

Target enrollment:
0

Participant gender:
All

Summary

To investigate the effectiveness of three (3) IV diuretic regimens to increase natriuresis in volume-overloaded HF patients, allowing for better decongestion and potentially resulting in improved clinical and biochemical parameters outcome.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Rambam Health Care Campus

Treatments:

Acetazolamide
Furosemide
Magnesium citrate
Metolazone

Criteria

Inclusion Criteria:

1. Signed written informed consent must be obtained before any study assessment is
performed.

2. Male or female patients 18 years of age or older

3. Confirmed Diagnosis of Heart Failure (per ESC guidelines 20212)

4. At least one sign of active congestion at recruitment: Jugular venous
pressure(JVP)/Ascites/Edema/Pulmonary rales/Pleural effusion/ Lung ultrasound B lines
>3 lines (at 6 sites).

5. Patient is at least on two heart failure drugs including: BB, MRA, sGLT2i,
ACEI/ARB/ARNI (or has a clinical reason for its absence) and on oral diuretics for the
last 30 days before study inclusion.

Exclusion Criteria:

1. History of myocardial infraction in the last 14 days prior to patient randomization.

2. History of a cardiac transplantation and/or ventricular assist device.

3. Mean blood pressure <60 mmHg at screening

4. Simultaneous use of intravenous inotropes, vasopressors or nitroprusside due to acute
decompensated heart failure in the last 14 days.

5. Estimated glomerular filtration rate <20ml/min/1.73m2 at screening

6. Any circumstances where urine collection is not possible.

7. Use of renal replacement therapy or ultrafiltration 30 days prior to patient
randomization.

8. Subjects who are pregnant or breastfeeding