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. 2020 Nov 4;2020(11):CD013004. doi: 10.1002/14651858.CD013004.pub2

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:
  • Improvement in 6‐minute walk test

  • Peak VO2 as assessed by cardio‐pulmonary exercise testing. The VO2 is calculated using the difference between the heart rate at rest and at peak exercise. The heart rate blood pressure and concentration of inspired oxygen will be monitored regularly by monitors.


Secondary outcome:
  • RV volume as assessed on cardiac magnetic resonance imaging

  • Diastolic parameters of E/E', E/A ratio on echocardiogram

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