ACTRN12612000710820.
Study name | Novel interventions in heart failure with preserved ejection fraction using ivabradine |
Methods |
Study design: Single‐centre, randomised, double‐blinded, placebo cross‐over pilot study Unit of randomisation: Blocking is used to ensure that comparison groups will be generated according to a predetermined ratio, usually 1:1 or groups of approximately the same size. Total duration of study: 18 weeks Intervention time: 18 weeks Follow‐up: No information Setting: Department of Cardiovascular Medicine, Flinders Medical Centre, Bedford Park, South Australia |
Participants |
Type of heart failure: HF‐PEF N = 20 participants Age: > 18 years Gender: Both males and females Inclusion criteria: 1. Age ≥ 18 years 2. HF‐PEF (LVEF ≥ 50% within 6 months of randomisation) 3. NYHA II‐III 4. Diastolic dysfunction on echo 5. E/A = 1, E/E’ ≥ 15, deceleration time ≤ 140 ms 6. Heart rate over 70/min 7. Stable disease, confirmed by no hospital admissions or HF medication changes within 3 months prior to randomisation 8. Informed consent 9. No other causes for exertional dyspnoea Exclusion criteria: 1. Atrial fibrillation 2. Contraindications to MRI 3. Significant valvular or coronary disease as primary cause of HF 4. Hypertrophic cardiomyopathy, cardiac amyloidosis, sarcoidosis 5. GFR ≥ 45 mL/min |
Interventions |
Intervention: Ivabradine max. 5 to 7.5 mg Comparison: Placebo (microcellulose oral capsule twice daily) Concomitant medications: No information Excluded medications: No information |
Outcomes |
Outcomes and time points measured in the study: [Baseline, 8, 18 weeks] Primary outcome:
Secondary outcome:
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Starting date | No information |
Contact information | Dr Govindarajan Srinivasan Department of Cardiovascular Medicine Flinders Medical Centre, 1, Flinders Drive Bedford Park, SA, 5042 Australia Phone: +61‐08‐82017916 Fax: +61‐08‐82017701 Email: Govindarajan.Srinivasan@health.sa.gov.au |
Notes |
Funding source category: Self‐funded/unfunded Primary sponsor type: Other collaborative groups Name: South Australian Health and Medical Research Institute Ethics status: Approved by Southern Adelaide Clinical Human Research Ethics Committee |