- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04618601
Diuretic and Natriuretic Effect of High-dose Spironolactone in Patients With Acute Heart Failure (DANAUS-AHF)
Study Overview
Status
Intervention / Treatment
Detailed Description
Congestion represents a hallmark feature of ADHF, which is present in more than 90% of patients hospitalized for this diagnosis. Intravenous loop diuretics are the mainstay of treatment. Nonetheless, nearly half of the patients who are hospitalized for AdHF continue to have residual symptoms and sign of congestion at time of discharge. Various pharmacological and non-pharmacological interventions have been proposed over the past years as potential means for relieving congestion in hospitalized ADHF patients. However, their efficacy has not been shown.
Given that hyperaldosteronism is a key feature in HF, the hypothesis that administration of high doses of spironolactone can potentiate the natriuretic effects of loop diuretics and relieve congestion in the setting of ADHF has been raised.
According to the most recent guidelines spironolactone can be considered in combination with loop diuretic in patients with resistant edema or insufficient symptomatic response. However, spironolactone at a dose of 100 mg daily has failed to increase diuresis in patients with ADHF.
The present study will assess the effect of high per os doses of spironolactone (≥100mg) on top of SOC treatment compared with SOC treatment alone on diuresis, natriuresis, weight loss and levels of NT-proBNP in hospitalized patients with ADHF.
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
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Attiki
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Athens, Attiki, Greece, 11527
- Laiko General Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Diagnosis of acute heart failure within the past 8 hours
- Two of the following: 1. edema, 2. ascites, 3. jugular vein distention, 4. pulmonary congestion
- NT-proBNP >1,000 pg/ml or >3,000 pg/ml (in the presence of atrial fibrillation)
- Per os mean daily loop diuretic dose equivalent to 80 mg of furosemide for at least 1 month prior to presentation and at least one of the following: 1. serum urea/serum creatinine > 50 at presentation, 2. serum creatinine increased >0.3 mg/dl compared with previous value (within the last year), 3. serum creatinine > 1.8 mg/dl.
Exclusion Criteria:
- pregnancy or breast feeding
- current acute coronary syndrome
- significant valvular disease
- pulmonary embolism
- allergy or intolerance to spironolactone
- current mechanical circulatory support
- primary hypertrophic cardiomyopathy, infiltrative cardiomyopathy
- mean arterial pressure <65mmHg or systolic arterial pressure <90 mmHg at presentation
- anticipated use of inotropes or vasodilators (other than renal doses of dopamine, i.e. <2.5 μg/kg/min)
- anticipated need of ultrafiltration
- exposure to nephrotoxic agents within 3 days of presentation
- serum potassium> 5 mmol/L
- per os receipt of spironolactone or eplerenone in a dose > 50 mg daily prior to presentation.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: High-dose spironolactone
Participants in this arm will receive high doses of per os spironolactone, defined as doses ≥100 mg daily, on top of standard of care treatment for acute heart failure
|
Patients randomized to the high-dose spironolactone group will receive oral spironolactone (≥100 mg) on top of standard of care treatment for acute heart failure immediately after randomization and in the afternoon of each subsequent day unless the serum potassium level is >5 mmol/L.
The exact dose will be determined based on a pre-specified algorithm provided.
Other Names:
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NO_INTERVENTION: Standard of care
Participants in this arm will standard of care treatment for acute heart failure, which may include per os spironolactone at a maximum dose of 50 mg daily
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Daily urine output
Time Frame: 5 days
|
Urine output in liters per 24 hours will be tracked from enrollment to day 5.
|
5 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total urine output
Time Frame: 5 days
|
Urine output in total liters from enrollment to day 5 will be measured.
|
5 days
|
Total weight change
Time Frame: 5 days
|
Patient weight in kilos will be tracked from enrollment to day 5.
|
5 days
|
Daily weight change
Time Frame: 5 days
|
Patient weight in kilos will be tracked from enrollment to day 5.
|
5 days
|
Natriuresis on days 1, 3 and 5
Time Frame: 5 days
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Urine sodium will be measured on days 1, 3 and 5
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5 days
|
Changes in natriuresis between days 1, 3 and 5
Time Frame: 5 days
|
Urine sodium will be measured on days 1, 3 and 5
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5 days
|
Changes in NT-proBNP between days 1 and 5
Time Frame: 5 days
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NT-proBNP will be measured on days 1, 3 and 5
|
5 days
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: John Barbetseas, MD, Laikon General Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15606
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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