Last updated on June 2019

Spironolactone Initiation Registry Randomized Interventional Trial in Heart Failure With Preserved Ejection Fraction

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Heart Failure With Preserved Ejection Fraction
  • Age: Between 50 - 99 Years
  • Gender: Male or Female

Inclusion Criteria:

  • Written informed consent
  • Age 50 years
  • Stable heart failure defined by symptoms and signs of heart failure as judged by local Investigator
  • Left ventricular ejection fraction (LVEF) 40% recorded in last 12 months (stratified to max 2/3rd in either 40-49% or 50% group)
  • NT-proBNP (the N-terminal prohormone of brain natriuretic peptide) >300 ng/L in sinus rhythm or >750 ng/L in atrial fibrillation as an outpatient or prior to hospital discharge

Exclusion Criteria:

Previously enrolled in this study

  • Known Ejection Fraction < 40% ever
  • Current absolute indication or contraindication for MRA (mineral receptor antagonist) in judgement of Investigator
  • Any condition other than heart failure with a life expectancy < 3 years
  • Known chronic liver disease
  • Probable alternative explanations for symptoms:
  • Known primary cardiomyopathy (hypertrophic, constrictive, restrictive, infiltrative, congenital)
  • Primary hemodynamically significant valve disease
  • Right-sided HF not due to left-sided HF
  • Significant chronic pulmonary disease defined by Investigator or by requirement for home O2 or oral steroids,
  • Hemoglobin < 10 g/dL (100 g/L )
  • Heart rate > 110bpm
  • Any other condition judged by Investigator to be responsible for symptoms and/or signs
  • Heart transplant or LVAD (left ventricular assist device) recipient
  • Presence of cardiac resynchronization therapy (CRT) device
  • Systolic blood pressure <90 or >160
  • K (potassium) >5.0 mmol/L
  • eGFR (estimated glomerular filtration rate) by MDRD (Modification of Diet in Renal Disease) < 30 ml/min/1.73m2 or creatinine > 2.5 mg/dL (221 mol/L )
  • Current lithium use
  • Current dialysis
  • Actual or potential for pregnancy
  • Participation in another interventional clinical trial where a mineralocorticoid receptor antagonist is studied
  • Any condition that in the opinion of the Investigator may interfere with adherence to trial protocol

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

Volunteer Sign-up

Sign up for our FREE service to receive email notifications when clinical trials are posted in the medical category of interest to you.