ChiCTR‐IIR‐17013377.
Study name | Efffect of ivabradine in heart failure with preserved ejection fraction: a multicenter and randomized controlled clinical trial |
Methods |
Study design: Multicentre randomised controlled clinical trial (parallel) Unit of randomisation: Random sequence generated by SPSS software (19.0) Total duration of study: 31 December 2017 to 30 April 2018 Intervention time: No information Follow‐up: No information Setting: Department of Cardiology, The First Affiliated Hospital, Sun Yat‐sen University |
Participants |
Type of heart failure: HF‐PEF N = 60 participants (30 intervention; 30 placebo) Age: 18 to 70 years Gender: Both males and females Inclusion criteria:
Exclusion criteria: 1. Severe valvular disease, primary hypertrophic or restrictive cardiomyopathy, and systemic illness associated with infiltrative heart disease 2. Permanent atrial fibrillation or recent (< 3 months) atrial fibrillation‐related hospitalisation, pacemaker carriage 3. Severe or uncontrolled hypertension (systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg) 4. Treatments not allowed at inclusion and during the study included non‐dihydropyridine calcium channel blockers, class I antiarrhythmics, and strong inhibitors of cytochrome P450 3A4 5. Heart rate < 60 beats/min; sick sinus syndrome; second‐ and third‐degree atrioventricular block 6. Established or suspected pulmonary diseases, sever joint‐associated disease, COPD, pulmonary hypertension 7. ACS in recent 2 months or coronary revascularisation in recent 6 months |
Interventions |
Intervention: Ivabradine Comparison: Placebo Concomitant medications: No information Excluded medications: Non‐dihydropyridine calcium channel blockers, class I antiarrhythmics, and strong inhibitors of cytochrome P450 3A4 |
Outcomes |
Outcomes and time points measured in the study: [1, 4 weeks] Primary outcome: VO2 peak Measure method: Cardiopulmonary Exercise Testing |
Starting date | 31 December 2017 |
Contact information | Cao Yalin Department of Cardiology, The First Affiliated Hospital, Sun Yat‐sen University 58 Second Zhongshan Road Yuexiu District Guangzhou, Guangdong China Phone: +86 13650917403 Email: 1132909739@qq.com |
Notes |
Primary sponsor: The First Affiliated Hospital of Sun Yat‐sen University
Secondary sponsor:
Ethics status: Approved by ICE for clinical research and animal trials of the First Affiliated Hospital of Sun Yat‐sen University |