Spironolactone in myocardial dysfunction with reduced exercise capacity

Effects of spironolactone or control on LV filling pressure and exercise capacity in patients with myocardial dysfunction with reduced exercise capacity

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614000088640

Acronym

STRUCTURE

Enrollment

150

Registered

2014-01-23

Start date

2011-11-01

Completion date

2015-02-01

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The main aim of this study is to use aldosterone blockade for the treatment of exercise intolerance in the presence of diastolic dysfunction (DD) and preserved LV systolic function. The responses will be sought by measurement of: 1) exercise capacity, 2) techniques to quantify myocardial structure and function. Our primary hypotheses are that spironolactone therapy is associated with improved; 1. Exercise capacity by reduction of myocardial fibrosis and improvement in LV compliance with aldosterone blockade, 2. Post-exercise LV filling pressure. Our secondary hypotheses are that spironolactone therapy is associated with; 3. Avoidance of a hypertensive response to exercise, 4. Improvements in myocardial deformation properties.

Interventions

Oral spironolactone will be administered in a dose of 25 mg daily for 6 months. Patients will be reviewed and serum electrolytes will be performed after a week, then monthly for 3 months, then at the end of the study: study medication will be withheld in the presence of hyperkalemia (>5.4 mmol/l), renal impairment (creatinine >0.18 mmol/l) or unacceptable side-effects. Adherence will be monitored by tablet counts.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

Patients with exercise intolerance, who are found to demonstrate increased E/E’ at exercise echo with reduced exercise capacity. Exercise intolerance will be defined by exercise capacity reduced from published normal ranges.

Exclusion criteria

(1) atrial fibrillation (2) ischemia evidenced by angina or a positive diagnostic test (3) patients already on spironolactone (4) patients with renal impairment (creatinine > 1.5 mg/dl) or hyperkalaemia (> 5.5 mmol/L).

Outcome results