Spironolactone in the Treatment of Heart Failure

Summary

The purpose of this study is to determine whether the treatment of patients with HFmrEF and HFpEF at high risk of cardiovascular events with the mineralocorticoid receptor antagonist (MRA) spironolactone reduces a composite of recurrent heart failure hospitalizations and cardiovascular mortality.

Conditions

• Heart Failure with Mid-range Ejection Fraction
• Heart Failure with Preserved Ejection Fraction

Interventions

DRUG

Experimental: Spironolactone

Spironolactone (an aldosterone antagonist) in tablet form taken daily. The initial study drug dose is 25 mg/day (one tablet) and may be titrated up to 50 mg/day (two tablets) within 4 weeks if kidney function at VR was \> 30 mL/min/m2 and potassium \< 4.5 mmol/L.

DRUG

Placebo Comparator

Placebo of Spironolactone in tablet form taken daily with dosage escalation rules in accordance with dosage of the study drug Spironolactone.

Sponsors & Collaborators

• Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)

  collaborator OTHER

• Echo Core Lab Berlin

  collaborator UNKNOWN

• University of Göttingen

  collaborator OTHER

• University Medicine Greifswald

  collaborator OTHER

• Ludwig-Maximilians - University of Munich

  collaborator OTHER

• Institute for Cardiovascular Computer-assisted Medicine, Charité

  collaborator UNKNOWN

• Coordinating Centre for Clinical Trials, Charité

  collaborator UNKNOWN

• Charite University, Berlin, Germany

  lead OTHER

Principal Investigators

• Burkert Pieske, Prof. MD · Charité University of Medicine

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

50 Years

Max Age

100 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-11-01

Primary Completion

2024-10-01

Completion

2024-10-01

Countries

• Austria
• France
• Germany
• Netherlands
• Serbia

Study Locations