Effect of spironolactone versus placebo in patients with a hypertensive response to exercise

The effect of spironolactone versus placebo on fibrosis in patients with a hypertensive response to exercise

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000835246

Acronym

HRE trial

Enrollment

120

Registered

2009-09-25

Start date

2006-09-12

Completion date

Unknown

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 aims of this study are to show that patients with hypertension and abnormal left ventricular (LV) filling (but without coronary artery disease) may have their echocardiographic and biochemical markers of myocardial fibrosis and diastolic function improved by treatment with spironolactone, an aldosterone antagonist with anti-fibrotic properties.

Interventions

1) Spironolactone oral, 25 mg/d, 3 months 2) Exercise - 30 minute sessions of aerobic and resistance training, 5 days per week for 3 months, iincluding 2 supervised small group sessions with an exercise physiologist. 3) Participants receive these interventions sequentially (ie there are 2 separate treatment arms) 4) The washout interval will be at least 3 months

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Prevention

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

Hypertensive response to exercise (HRE); maximum SBP/DBP (systolic/diastolic blood pressure) response to exercise >210/105 mmHg in men and >190/105 mmHg for women

Exclusion criteria

1) hypertension at rest (>140/90 mmHg or on treatment for hypertension), 2) known coronary artery disease (angina, previous infarction, previous positive diagnostic test), 3) diabetes mellitus

Outcome results