Status:
UNKNOWN
Tailoring Pacemaker Output to Physiology in Chronic Heart Failure
Lead Sponsor:
University of Leeds
Conditions:
Chronic Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Aims: To explore the clinical effect on exercise tolerance and quality of life, safety and tolerability of pacing at higher outputs in patients with chronic heart failure and a pacemaker. Background:...
Detailed Description
ORIGINAL HYPOTHESIS Increasing pacemaker left ventricular stimulation output is safe and well-tolerated, and increases acute and longer term exercise capacity and quality of life through improved left...
Eligibility Criteria
Inclusion
- Symptomatic heart failure due to left ventricular systolic dysfunction (LVEF\<50%)
- Willing and able to give informed consent
- CRT-D or CRT-P device in situ (\>6 months)
Exclusion
- Angina pectoris symptoms limiting exercise tolerance
- Unstable heart failure symptoms (medical therapy changes in last three months)
- Poor imaging quality (details of patients excluded for this reason will be recorded)
- Calcium channel blocker use (these depress the force of contraction at all heart rates)
- Uncontrolled heart rate (either atrial fibrillation or sinus rhythm (\>80bts/min))
- Co-morbidities significantly affecting exercise or symptoms such as severe chronic airways disease or arthritis
- Haemodynamically significant aortic stenosis
Key Trial Info
Start Date :
February 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2023
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT03781427
Start Date
February 1 2020
End Date
August 1 2023
Last Update
November 2 2022
Active Locations (1)
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1
Leeds General Infirmary
Leeds, United Kingdom