Phase 2
Completed N=360
Study of High-dose Spironolactone vs. Placebo Therapy in Acute Heart Failure
Source: ClinicalTrials.gov NCT02235077 ↗Enrolled (actual)
360
Serious AEs
9.4%
Results posted
May 2017
Primary outcomePrimary: 96 Hour Change in NT-proBNP — -0.58; -0.61 log pg/ml — p=0.5688
Summary
The primary objective of this study is to test the hypothesis that high-dose spironolactone will lead to greater proportional reduction in NT-proBNP levels from randomization to 96 hours over standard of care.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 96 Hour Change in NT-proBNP |
-0.58; -0.61 | 0.5688 |
| SECONDARY 96 Hour Change in Clinical Congestion Score |
-5.59; -5.82 | 0.4155 |
| SECONDARY 96 Hour Change in Dyspnea Likert Score |
64; 79; 56; 39; 24; 18 | 0.3039 |
| SECONDARY 96 Hour Change in Serum Creatinine |
0.15; 0.16 | 0.7673 |
| SECONDARY 96 Hour Net Fluid Output |
5824; 5507 | 0.5734 |
| SECONDARY 96 Hour Change in Body Weight |
-8.1; -7.5 | 0.3528 |
| SECONDARY 96 Hour Change in Serum Potassium Levels |
0.31; 0.15 | 0.0846 |
| SECONDARY Change in Loop Diuretics Requirements From Baseline to 30 Days |
19.66; 30.70 | 0.0842 |
| SECONDARY Presence of Outpatient Worsening Heart Failure Symptoms Through Day 30 |
19; 17 | 0.7628 |
| SECONDARY 96 Hour Change in Dyspnea Visual Analog Scale |
17.2; 17.9 | 0.6102 |
Eligibility Criteria
Inclusion Criteria
- Male or female patient ≥21 years old
- Admitted to hospital for AHF with at least 1 symptom (dyspnea, orthopnea, or fatigue) and 1 sign (rales on auscultation, peripheral edema, ascites, pulmonary vascular congestion on chest radiography) of congestion
- Patient must be randomized within 24 hours of first IV diuretic dose administered for the current episode of decompensation (regardless of where the diuretic was given e.g. office, ED, ambulance, hospital etc.)
- Estimated GFR of ≥30 mL/min/1.73m2 determined by the MDRD equation
- Serum K+ ≤5.0 mmol/L at enrollment
- NT-proBNP ≥1000 pg/mL or BNP ≥250 pg/mL, measured within 24h from randomization
- Not on MRA or on low-dose spironolactone (12.5 mg or 25 mg daily) at baseline
Exclusion Criteria
- Taking eplerenone or >25 mg spironolactone at baseline
- eGFR 5.0 mmol/L. If a repeat measurement within the enrollment window is 3 x normal, alkaline phosphatase or bilirubin >2x normal)
- Active infection (current use of oral or IV antimicrobial agents)
- Active gastrointestinal bleeding
- Active malignancy other than non-melanoma skin cancers
- Current or planned mechanical circulatory support within 30 days
- Post cardiac transplant or listed for transplant and expected to receive one within 30 days
- Current inotrope use
- Complex congenital heart disease
- Primary hypertrophic cardiomyopathy, infiltrative cardiomyopathy, acute myocarditis, constrictive pericarditis or tamponade
- Previous adverse reaction to MRAs
- Enrollment in another randomized clinical trial during index hospitalization
Data sourced from ClinicalTrials.gov (NCT02235077). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.