Exploring Diuretics Effective Management in Acute Decompensated Heart Failure, EDEMA Trial

NCT03863626 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2021-01-27

No results posted yet for this study

Summary

1. Evaluate efficacy and safety of continuous infusion of IV Frusemide compared to IV shots in acute decompensated heart failure ADHF
2. Evaluate superiority of time-adjusted metolazone to morning frusemide IV shots compared to irrespective administration (at random times) to overcome diuretic resistance

Conditions

  • Acute Decompensated Heart Failure
  • Diuretics Resistance

Interventions

OTHER

Frusemide IV shots

giving frusemide by IV shots And if developed diuretic resistance (diminishing diuretic effect despite incremental dose of IV loop diuretic), adjuvant oral Metolazone will be given for sequential nephron blockade comparing its administration timed 60 minutes prior to the morning Frusemide shot versus given after. (This will be in a second level of randomization)

OTHER

Frusemide IV infusion

giving frusemide by continuous IV infusion And if developed diuretic resistance (diminishing diuretic effect despite incremental dose of IV loop diuretic), adjuvant oral Metolazone will be given for sequential nephron blockade

Sponsors & Collaborators

  • Kasr El Aini Hospital

    collaborator OTHER
  • Cairo University

    lead OTHER

Principal Investigators

  • Ahmed Shehata, MD · Cairo University

  • Magdy Abdelhamid, MD · Cairo University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-31
Primary Completion
2021-12-31
Completion
2021-12-31

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03863626 on ClinicalTrials.gov