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

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:
  • Aged 18~70 years

  • With a history of symptomatic chronic heart failure of at least 3 months (NYHA class II or III), to receive the optimal treatment and to be in a stable clinical condition

  • EF% ≥ 50%

  • At least 1 predefined echocardiographic criterion related to diastolic dysfunction as evaluated by the investigating site:

    • echo‐Doppler E/e' ratio of > 13;

    • e' lateral < 10 cm/s and e′ septal < 8 cm/s;

    • indexed volume of the left atrium (LAVI) of > 34 mL/m2 E/e' = ratio of peak early diastolic mitral flow velocity divided by the mean of the annular lateral (e′ lateral) and septal (e′ septal) velocities.

  • Patient enrolment were exercise capacity < 80% of age‐predicted and sex‐predicted normal ranges in Cardiopulmonary Exercise Testing.


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:
  • Nanfang Hospital, Southern Medical University

  • Military General Hospital of Guangzhou

  • The First People's Hospital of Guangzhou


Ethics status: Approved by ICE for clinical research and animal trials of the First Affiliated Hospital of Sun Yat‐sen University