Acetazolamide and Spironolactone to Increase Natriuresis in Congestive Heart Failure
Information source: Hasselt University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Heart Failure
Intervention: Combination therapy with acetazolamide and low-dose loop diuretics (Drug); High-dose loop diuretics (Drug); Upfront therapy with oral spironolactone (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Hasselt University Official(s) and/or principal investigator(s): Wilfried Mullens, M.D. Ph.D., Principal Investigator, Affiliation: Ziekenhuis Oost-Limburg Frederik H. Verbrugge, M.D. Ph.D., Principal Investigator, Affiliation: Ziekenhuis Oost-Limburg
Overall contact: Frederik H. Verbrugge, M.D. Ph.D., Phone: +32473924199, Email: frederik.verbrugge@zol.be
Summary
This study has two primary objectives:
1. To compare combination therapy with acetazolamide and low-dose loop diuretics versus
high-dose loop diuretics (standard of care) in patients with acute decompensated heart
failure at high risk for diuretic resistance.
2. To demonstrate the safety and efficacy of upfront therapy with spironolactone in
addition to loop diuretic therapy in patients with acute decompensated heart failure at
high risk for diuretic resistance.
Clinical Details
Official title: Diamox/Aldactone to Increase the URinary Excretion of Sodium: an Investigational Study in Congestive Heart Failure
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Acetazolamide arm: natriuresis 24 hSpironolactone arm: incidence of hypo- (serum potassium <3.5 mmol/L) or hyperkalemia (serum potassium >5.0 mmol/L)
Secondary outcome: NT-proBNP change after 72 hWorsening renal function Persistent renal impairment Peak plasma aldosterone concentration after 72 h Peak plasma renin activity after 72 h
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Older than 18 years and able to give informed consent
- Clinical diagnosis of acute decompensated heart failure within the previous 8 h
- At least two clinical signs of congestion (edema, ascites, jugular venous distension,
or pulmonary vascular congestion on chest radiography)
- Maintenance therapy with oral loop diuretics at a dose of at least 1 mg bumetanide (1
mg bumetanide = 40 mg furosemide = 20 mg torsemide) for at least 1 month before
hospital admission
- NT-proBNP >1000 ng/L
- Left ventricular ejection fraction <50%
- At least one out of three of the following criteria:
- Serum sodium <136 mmol/L
- Serum urea/creatinine ratio >50 (comparable to a BUN/creatinine ratio >25)
- Admission serum creatinine increased with >0. 3 mg/dL compared to previous value
within 3 months before admission
Exclusion Criteria:
- History of cardiac transplantation and/or ventricular assist device
- Concurrent diagnosis of an acute coronary syndrome defined as typical chest pain
and/or electrocardiographic changes in addition to a troponin rise >99th percentile
- Mean arterial blood pressure <65 mmHg, or systolic blood pressure <90 mmHg at the
moment of admission
- Use of intravenous inotropes, vasopressors or nitroprusside at any time point during
the study
- A baseline estimated glomerular filtration rate <15 mL/min/1. 73m² according to the
Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula at the moment of
inclusion
- Use of renal replacement therapy or ultrafiltration before study inclusion
- Treatment with acetazolamide within the previous month
- Treatment with ≥2 mg bumetanide or an equivalent dose during the index
hospitalization before randomization
- Use of diuretics, vasopressin antagonists or mineralocorticoid receptor antagonist
not specified by the protocol
- Exposure to nephrotoxic agents (i. e. contrast dye) anticipated within 3 days
Locations and Contacts
Frederik H. Verbrugge, M.D. Ph.D., Phone: +32473924199, Email: frederik.verbrugge@zol.be
Ziekenhuis Oost-Limburg, Genk, Limburg 3600, Belgium; Recruiting Pieter Martens, M.D., Phone: +3289321516, Email: pieter_martens@icloud.com Petra Nijst, M.D., Phone: +3289321525, Email: petra.nijst@zol.be Frederik H. Verbrugge, M.D. Ph.D., Principal Investigator Wilfried Mullens, M.D. Ph.D., Principal Investigator Petra Nijst, M.D., Sub-Investigator Philippe B. Bertrand, M.D. M.Sc., Sub-Investigator Lars Grieten, Ph.D. M.Sc., Sub-Investigator Matthias Dupont, M.D., Sub-Investigator Joris Penders, M.D. Ph.D., Sub-Investigator Pieter Martens, M.D., Sub-Investigator
University Hospital Leuven, Leuven, Vlaams-Brabant 3000, Belgium; Not yet recruiting Walter Droogné, M.D., Phone: +3216343487, Email: walter.droogne@uzleuven.be Anne Strijckmans, R.N., Phone: +3216343487, Email: anne.strijckmans@uzleuven.be
Additional Information
Starting date: November 2013
Last updated: August 2, 2015
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