Effect of 25 and 100 mg spironolactone on quality of life, ejection fraction and readmission in systolic heart failure patients with reduced ejection fractio

Phase 3

• Conditions: Systolic heart failure.; Systolic (congestive) heart failure; I50.2

• Registration Number: IRCT20220404054403N1
• Lead Sponsor: Ahvaz University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 27 June 2022

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 94

Inclusion Criteria

Acute systolic heart failure (EF <40)
A history of hospitalization in the last 6 months

Exclusion Criteria

Known contraindications for spironolactone or prior documented intolerance  to an aldosterone receptor antagonist
Significant laboratory abnormalities (potassium = 5.1 mmol)
Mental disorders suspected to interact with study outcome
Pregnant or nursing women
Significant renal dysfunction
Significant hypotension (lower than 90 mm Hg systolic or 60 mm Hg diastolic)
CRT or ICD

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ejection fraction. Timepoint: Before the intervention and 6 months after drug administration. Method of measurement: Echocardiography.;Quality of life. Timepoint: Before the intervention and 6 months after drug administration. Method of measurement: Minnesota Questionnaire.;Readmission. Timepoint: Before the intervention and 6 months after drug administration. Method of measurement: 6 MIN Walk test.