Health TrialsbyHealthPanel

Add-on Diuretics in Acute Decompensated Heart Failure

ConditionAcute Decompensated Heart Failure
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorTanta University

About this trial

The aim of this study is to compare the efficacy and safety of empagliflozin, acetazolamide, and metolazone as add-on therapies to loop diuretics in patients with acute decompensated heart failure.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female patients older than 18 years.

Hospital admission with clinical diagnosis of acute decompensated heart failure with at least one clinical sign of volume overload (e.g. edema, ascites confirmed by echography or pleural effusion confirmed by chest X-ray or echography).

Disqualifiers

Type 1 diabetes.

Chronic kidney disease with estimated glomerular filtration rate (eGFR) <30 mL/min per 1.73 m² or end-stage kidney failure with the need for chronic dialysis treatment.

A systolic blood pressure of less than 90 mmHg.

Cardiogenic shock.

Trial design

Design model

Parallel

Treatments tested in this trial

  • empagliflozin

    Drug

    Empagliflozin may augment the natriuretic and aquaretic actions of loop diuretics in patients with acute decompensated heart failure and it does not typically cause electrolyte disturbances and has been shown to improve outcomes in patients with heart failure

  • Acetazolamide

    Drug

    Acetazolamide can augment the action of loop diuretics in patients with acute decompensated heart failure

  • metolazone

    Drug

    Metolazone can augment the action of loop diuretics in patients with acute decompensated heart failure

Treatment groups

66 Participants
are divided into 3 treatment groups
Group A: Empagliflozin groupActive comparator 1 intervention
Group B: Acetazolamide groupActive comparator 1 intervention
Group C: Metolazone groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

The cumulative urine output measured over 3 days

Time frame
3 days

Secondary outcomes

1

- The change in serum level of N-terminal pro-brain natriuretic peptide (NT-proBNP)

Blood samples will be collected at baseline and after 4 days

Time frame
4 days
2

The change in serum level of Soluble suppression of tumorigenicity 2 (sST2)

Blood samples will be collected at baseline and after 4 days

Time frame
4 days
3

The change in urinary level of Tissue inhibitor of metalloproteinases-2 (TIMP-2 )

Urine samples will be collected at baseline and after 3 days

Time frame
3 days
4

The change in urinary level of Insulin-like growth factor-binding protein 7 (IGFBP7)

Urine samples will be collected at baseline and after 3 days

Time frame
3 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tanta University

Lead sponsor

Source ClinicalTrials.gov
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