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CompletedPhase 3Phase 4ACTRN12610001087044

Use of exercise and medical therapies to improve cardiac function among patients with exertional shortness of breath due to lung congestion

Exertional dyspnoea with increased filling pressure - Mechanisms and treatment strategies

Sponsor

University of Queensland

Enrollment

150 participants

Start Date

Jun 1, 2007

Study Type

Interventional

Conditions

Diastolic dysfunction, heart failure with preserved ejection fraction (HFpEF)

Summary

Previous studies of “diastolic heart failure” have been limited by confusion about the definition of this entity, and evidence for specific treatments are undefined. The characterization of IFPE will permit us to identify a homogeneous group. However, the most appropriate therapeutic response to increased filling pressure causing exertional dyspnea is undefined.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 80 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests whether exercise and certain medications can improve heart function in patients who get short of breath during physical activity due to fluid buildup in the lungs. Adults aged 18 to 80 with reduced exercise capacity and signs of lung congestion during exertion may be eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Patients will be randomly allocated to; daily oral doses of ivabradine 5mg, isosorbide mononitrate 120mg, or placebo for 7 days. Assessment of cardiovascular function will be performed at rest and exe

Patients will be randomly allocated to; daily oral doses of ivabradine 5mg, isosorbide mononitrate 120mg, or placebo for 7 days. Assessment of cardiovascular function will be performed at rest and exercise at baseline and after the intervention. After a 2 week wash-out, patients will be re-randomised to an exercise training intervention, daily oral spironolactone 25mg or placebo (matching) tablet for 6 months. The exercise intervention will be supervised by an exercise physiologist, and will comprise aerobic and resistance training, for 3 x 60 minute sessions per week at 65-70% maximum heart rate. Assessment of cardiovascular function will be repeated after the intervention.

Locations(1)

Australia

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ACTRN12610001087044