Effect of Accelerated Pacing Rates on Exercise Tolerance, Quality of Life and Arrhythmia Burden in Patients with Evidence of Heart Failure with Preserved Ejection Fractio
- Conditions
- Heart failure with preserved ejection fractionSinus Node DiseaseCardiovascular - Other cardiovascular diseases
- Registration Number
- ACTRN12623001187639
- Lead Sponsor
- niversity of Adelaide
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 160
•Adults 18-80 years old with a pacemaker.
•Preclinical or clinical heart failure with preserved ejection fraction according to the diagnostic criteria of the HFA of the ESC.
•Sinus node dysfunction with intact AV node conduction or minimal RV pacing (<20%) and paced QRS <150ms.
OR
•Impaired AV node conduction with His bundle or left bundle branch area pacing, or biventricular pacing.
•Subject is expected to remain available for follow-up visits.
•Left ventricular ejection fraction <45%.
•Inability to participate in exercise testing due to musculoskeletal disease or other active diseases.
•Myocardial infarction within the past 12 months.
•Infiltrative cardiomyopathy.
•Hypertrophic cardiomyopathy.
•More than moderate valvular stenosis or regurgitation.
•Aortic valve replacement in the past one year.
•Significant primary pulmonary disease on home oxygen.
•Uncontrolled hypertension as defined by BP >160/100 mmHg on two measurements >15 minutes apart.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Peak oxygen consumption (VO2peak).[Cardiopulmonary exercise testing on an upright cycle ergometer, recorded by a metabolic cart. Baseline and 52-weeks post-randomisation. ]
- Secondary Outcome Measures
Name Time Method