None listed
Conditions
Brief 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.
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 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 co
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.
Sponsors
University of Queensland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
We intend to recruit patients who are found to demonstrate increased E/e’ at exercise echo with reduced exercise capacity. Exercise intolerance will be defined by either a previous exercise test with exercise capacity reduced >20% from published normal ranges or reduction of predicted exercise capacity based on the Duke Activity Status questionnaire
Exclusion criteria
(1) atrial fibrillation (variations in cycle length may be problematic for calculating E/E’), (2) ischemia evidenced by angina or a positive diagnostic test (where improvement of exercise capacity may be due to reduction of ischemia), (3) patients already on nitrate, ivabradine or spironolactone and (4) patients with renal impairment (creatinine > 0.18) or hyperkalaemia (> 5.5 mmol/L).
Outcome results
None listed