Study of High-dose Spironolactone vs. Placebo Therapy in Acute Heart Failure

Description

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.

Study Start Date

December 2014

Estimated Completion Date

June 2017

Interventions

  • Drug: Spironolactone
  • Drug: Placebo

Specialties

  • Cardiology: Clinical Pharmacology,Heart Failure
  • Pharmacy: Cardiac/Hypertension
  • Physician Assistant: Cardiology,Clinical Pharmacology

MeSH Terms

  • Heart Failure
  • Spironolactone

Study ID

Duke University -- Pro00057090

Status

Unknown

Trial ID

NCT02235077

Study Type

Interventional

Trial Phase

Phase 2

Enrollment Quota

360

Sponsor

Duke University

Inclusion Criteria

  • Male or female patient ?21 years old
  • Admitted to hospital for AHF with at least 1 symptom (dyspnea, orthopnea, or edema) 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 < 30 ml/min/1.73m2
  • Serum K+ >5.0 mmol/L. If a repeat measurement within the enrollment window is <5.0, the patient can be considered for inclusion.
  • Systolic blood pressure <90 mmHg
  • Hemodynamically significant arrhythmias or defibrillator shock within 1 week
  • Acute coronary syndrome currently suspected or within the past 4 weeks
  • Severe liver disease (ALT or AST >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

Gender

Both

Ages

21 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (22)

Study Location Distance Name Phone Email
Brigham and Womens Hospital - Boston, Massachusetts 2.6 miles Michael Givertz MD 617-732-7367 mgivertz@partners.org
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles Marc Semigran MD 617-726-8862 msemigran@partners.org
Tufts Medical Center - Boston, Massachusetts 3.2 miles Amanda Vest MD None avest@tuftsmedicalcenter.org
Boston VA Healtcare System - West Roxbury, Massachusetts 6.9 miles Neal Lakdawala MD 617-525-9574 nlakdawala@partners.org
Stony Brook University Medical Center - Stony Brook, New York 145.7 miles Hal Skopicki MD 631-444-1117 hal.skopicki@stonybrook.edu
The University of Vermont Fletcher Allen Health Care - Burlington, Vermont 181.7 miles Peter Van Buren MD 802-847-2879 peter.vanburen@vtmednet.org
Jefferson Medical College - Philadelphia, Pennsylvania 269.5 miles David Whellan MD 215-955-2636 david.whellan@jefferson.edu
University of Pennsylvania - Philadelphia, Pennsylvania 270.8 miles Kenneth Margulies MD 215-707-2006 ken.margulies@uphs.upenn.edu
Lancaster General Hospital - Lancaster, Pennsylvania 317.2 miles Mark Etter MD 717-397-5484 mdetter@lghealth.org
Johns Hopkins Hospital - Baltimore, Maryland 356.0 miles Ryan Tedford MD 410-955-7534 ryan.tedford@jhmi.edu
University Hospitals Case Medical Center - Cleveland, Ohio 544.0 miles Guilherme Oliveria MD 216-444-4036 guilherme.oliveira@uhhospitals.org
Cleveland Clinic - Cleveland, Ohio 544.9 miles Wilson Tang MD 216-444-2121 tangw@ccf.org
Metro Health System - Cleveland, Ohio 549.6 miles Mark Dunlap MD 216-778-2711 mdunlap@metrohealth.org
Duke University - Durham, North Carolina 608.4 miles Michael Felker MD 919-668-8919 michael.felker@duke.edu
Southeastern Regional Medical Center - Lumberton, North Carolina 685.5 miles Melvin Echols MD 910-386-1252 melvin.echols@dm.duke.edu
Emory University School of Medicine - Atlanta, Georgia 932.0 miles Andrew L Smith MD 404-778-5273 None
Washington University - St. Louis, Missouri 1,039.5 miles Justin Vader MD 314-677-5302 jvader@dom.wustl.edu
Saint Louis University Hospital - St. Louis, Missouri 1,042.3 miles Paul Hauptman MD 314-268-5293 hauptmpj@slu.edu
Mayo Clinic - Rochester, Minnesota 1,083.1 miles Margaret Redfield MD 507-284-1281 redfield.margaret@mayo.edu
Michael Debakey VA Medical Center - Houston, Texas 1,609.9 miles Anita Deswal MD 713-794-7441 adeswal@bcm.tmc.edu
University of Utah School of Medicine - Salt Lake City, Utah 2,094.1 miles Edward Gilbert MD 801-585-2340 edward.gilbert@hsc.utah.edu
Utah VA Medical Center - Salt Lake City, Utah 2,094.1 miles Edward Gilbert MD 801-585-2340 edward.gilbert@hsc.utah.edu

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