Acute Decompensated Heart Failure Clinical Trial
— EDEMAOfficial title:
Exploring Diuretics Effective Management in Acute Decompensated Heart Failure, EDEMA Trial
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
Status | Recruiting |
Enrollment | 400 |
Est. completion date | December 2021 |
Est. primary completion date | December 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - Age more than 18 years. - Chronic heart failure prior diagnosis, based on signs and or symptoms of heart failure, presenting with acute decompensation as judged by the physician to require hospitalization for IV diuretics Exclusion Criteria: - Refusal to participate in the study. - Allergy to IV frusemide. - Severe renal impairment defined as eGFR<30ml/m. - Cardiogenic shock or hemodynamic instability judged by the treating physician to be unsuitable to participate. |
Country | Name | City | State |
---|---|---|---|
Egypt | Faculty of Medicine, Cairo University Hospitals | Cairo |
Lead Sponsor | Collaborator |
---|---|
Cairo University | Kasr El Aini Hospital |
Egypt,
Damman K, Testani JM. The kidney in heart failure: an update. Eur Heart J. 2015 Jun 14;36(23):1437-44. doi: 10.1093/eurheartj/ehv010. Epub 2015 Apr 2. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to improvement of NYHA class | Time (in hours) to improvement of NYHA class | within 5 days | |
Primary | Diuretic efficiency | Urine output (in ml/kg/h) per 40 mg of frusemide given as shots vs continuous infusion. | 24 hours | |
Secondary | effectiveness of sequential nephron block | Assessing improvement of diuresis by adding of metolazone to frusemide in ADHF.patients who had developed diuretic resistance. | within 5 days of adding metolazone | |
Secondary | Evaluating superiority of timely adjusted metolazone compared to given at random in overcoming resistance to IV frusemide (only in IV shots arm) | Evaluating superiority of timely adjusted metolazone given 60 minutes prior to IV frusemide compared to when given at random in overcoming diuretic resistance (only in IV shots arm) | within 5 days of adding metolazone |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04049045 -
Effects of Empagliflozin on Diuresis and Renal Function in Patients With Acute Decompensated Heart Failure
|
Phase 2 | |
Active, not recruiting |
NCT05100836 -
SURPASS Impella 5.5 Study
|
||
Recruiting |
NCT02898181 -
Low Level Tragus Stimulation in Acute Decompensated Heart Failure
|
N/A | |
Completed |
NCT02823626 -
High-dose Aldosterone Antagonist for Acute Decompensated Heart Failure
|
||
Completed |
NCT02248831 -
Evaluation of Cardiopulmonary Diseases by Ultrasound
|
N/A | |
Completed |
NCT02196038 -
A Trial of Rehabilitation Therapy in Older Acute Heart Failure Patients
|
N/A | |
Completed |
NCT00693745 -
Neutrophil Gelatinase-Associated Lipcalin (NGAL) Evaluation Along With B-Type Natriuretic Peptide in Acutely Decompensated HF
|
N/A | |
Not yet recruiting |
NCT04391231 -
HEMolysis in a Percutaneous Axial Flow LVAD, Effects of Pentoxifylline in a Randomized Controlled Trial
|
Phase 4 | |
Recruiting |
NCT05206422 -
DORAYA-HF Early Feasibility Study
|
N/A | |
Recruiting |
NCT01960218 -
Gas Exchange for Predicting Hospital Heart Failure Readmissions
|
N/A | |
Terminated |
NCT00904488 -
Oral Metolazone and Intermittent Intravenous Furosemide Versus Continuous Infusion Furosemide in Acute Heart Failure
|
Phase 4 | |
Terminated |
NCT02620384 -
Metolazone As Early Add On Therapy For Acute Decompensated Heart Failure (MELT-HF)--A Single Center Pilot Study.
|
Phase 3 | |
Completed |
NCT04318093 -
Study of the Safety of BMS-986259 in Participants With Post-Acute Decompensated Heart Failure
|
Phase 2 | |
Recruiting |
NCT06161649 -
Mobile Education System to Improve Disease Knowledge, Self-efficacy and Quality of Life in Patients With Heart Failure
|
N/A | |
Completed |
NCT02289508 -
Role of USCOM in Adult Patients With Heart Failure
|
N/A | |
Terminated |
NCT01457053 -
Assessment of Coronary Flow Reserve in Heart Failure Patients After Ultrafiltration Versus Diuretics
|
N/A | |
Completed |
NCT04877652 -
DR REGISTRY: Prospective Observational Study of ADHF Patients With Insufficient Response to Diuretics
|
||
Completed |
NCT03505788 -
Acetazolamide in Decompensated Heart Failure With Volume OveRload (ADVOR)
|
Phase 4 | |
Completed |
NCT03146754 -
A Study to Evaluate Lung Ultrasound as a Method to Measure Changes in Extravascular Lung Water Induced by Positional Changes (LUPE)
|
N/A | |
Terminated |
NCT05346653 -
The Hemodynamic Effects of SGLT2i in Acute Decompensated Heart Failure
|
Phase 4 |