Acetazolamide and Spironolactone to Increase Natriuresis in Congestive Heart Failure

PHASE4CompletedINTERVENTIONAL
Enrollment

34

Participants

Timeline

Start Date

November 30, 2013

Primary Completion Date

April 30, 2017

Study Completion Date

October 31, 2017

Conditions
Heart Failure
Interventions
DRUG

Combination therapy with acetazolamide and low-dose loop diuretics

"* Patients receive 500 mg of intravenous acetazolamide immediately after randomization, with 250 mg intravenous acetazolamide administered on each consecutive day in the morning for as long as the patient is considered volume overloaded by his/her treating cardiologist.~* Patients receive 2 mg of intravenous bumetanide immediately after randomization, with 1 mg intravenous bumetanide administered on each consecutive day in the morning for as long as the patient is considered volume overloaded by his/her treating cardiologist.~* If diuresis \<1,5 L while the patient is still considered volume overloaded by his/her treating cardiologist, the dose of acetazolamide is maintained at 500 mg and the dose of bumetanide is maintained at 2mg.~In case of therapy-refractory congestion, treatment is at the discretion of the treating physician, but addition of chlorthalidone 50 mg PO is recommended by the investigators as a first-line option."

DRUG

High-dose loop diuretics

"* Patients receive the double of their daily maintenance dose of oral loop diuretics converted to mg bumetanide as an intravenous bolus after randomization.~* Patients continue to receive this dose daily on the next 3 days divided between two administrations with at least a 6 h interval for as long as they are considered volume overloaded by the treating cardiologist.~* If diuresis \<1,5 L while the patient is still considered volume overloaded by the treating cardiologist, the dose of bumetanide is doubled.~In case of therapy-refractory congestion, treatment is at the discretion of the treating physician, but addition of chlorthalidone 50 mg PO is recommended by the investigators as a first-line option."

DRUG

Upfront therapy with oral spironolactone

"Patients randomized to this group receive oral spironolactone (25mg) immediately after randomization and in the morning of each subsequent day unless the serum potassium level is \>5 mmol/L.~Note: Investigators and treating physicians are blinded to treatment allocation for this arm, but no matching placebo is provided, so patients are not."

Trial Locations (2)

3000

University Hospital Leuven, Leuven

3600

Ziekenhuis Oost-Limburg, Genk

All Listed Sponsors
collaborator

Ziekenhuis Oost-Limburg

OTHER

collaborator

Universitaire Ziekenhuizen KU Leuven

OTHER

lead

Hasselt University

OTHER

NCT01973335 - Acetazolamide and Spironolactone to Increase Natriuresis in Congestive Heart Failure | Biotech Hunter | Biotech Hunter