An interventional study of Remote Ischaemic Conditioning with exercise and Other: Remote Ischaemic Conditioning in Heart Failure With Preserved Ejection Fraction, Type 2 Diabetes and Dilated Cardiomyopathy, sponsored by University of Leicester. Status unknown at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-27.
Sponsored by University of Leicester · Not applicable, Interventional, and Treatment
This study will test the impact of remote ischaemic conditioning combined with exercise on myocardial perfusion in patients with or at risk of heart failure
Heart failure (HF) is a disease which affects the heart's ability to pump or fill with blood. It can affect a person's quality of life and their ability to exercise. Recent work has shown that a reduction in the blood supply to the heart may contribute to the problem. It is therefore possible that improving the blood supply to the heart may help patients with HF. One possible way that this might be achieved is with a method called remote ischaemic conditioning (RIC). This involves placing a cuff on a person's arm (identical to a blood pressure cuff) and inflating it for a few minutes to reduce the blood flow in a person's arm. This is thought to release chemicals into the bloodstream which can have positive effects on the heart. This has been studied in patients with other forms of heart disease, but is yet to be tested properly in patients with heart failure. It is hypothesized that combining the RIC procedure with a low level of arm exercise may result in further improvements in the person's blood vessels and heart. This will be tested in a single-centre prospective study.
9,589 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,332 are open to participants now.
This study's planned enrollment of 60 is below the median of 81 across 7,713 interventional studies indexed under Diabetes Mellitus, Type 2.
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Exclusion Criteria:
Participants will be randomised to receive remote ischaemic conditioning (RIC) with exercise involving a 4-week home-based programme of RIC with exercise . The exercise will involve handgrip exercise during the cuff deflation phase of RIC.
Device: Remote Ischaemic Conditioning with exercise
Participants will receive remote ischaemic conditioning (RIC) without exercise involving a 4-week home-based programme of RIC.
Device: Other: Remote Ischaemic Conditioning
Participants will receive RIC through an automated device that will provide cycles on ischaemia/reperfusion to the target organ (arm). During the cuff deflation phase, participants will undergo handgrip exercise at 20-30% of their maximal voluntary contraction for 3 minutes. There will be a total of 4 cycles of exercise.
Participants will receive RIC through an automated device that will provide cycles on ischaemia/reperfusion to the target organ (arm).. There will be a total of 4 cycles.
Myocardial perfusion reserve
myocardial perfusion reserve under adenosine stress as assessed by quantitative cardiovascular magnetic resonance (CMR)
Time frame: 4 weeks
Contraction strength in the cuff deflation phase of RIC
contraction force achieved during cuff deflation phase, measured in Newtons
Time frame: 1 day
Hyperaemic myocardial blood flow
myocardial blood flow under adenosine stress as assessed by quantitative cardiovascular magnetic resonance (CMR)
Time frame: 4 weeks
Brachial artery flow mediated dilation
endothelial function as assessed by vascular ultrasound
Time frame: 4 weeks
Skeletal muscle strength
maximal handgrip strength (newtons)
Time frame: 4 weeks
Skeletal muscle endurance
Isometric skeletal muscle endurance test assessed using handgrip dynamometer (sec)
Time frame: 4 weeks
Cardiopulmonary exercise test
VO2 max for maximal aerobic capacity
Time frame: 4 weeks
Brachial artery maximal dilatory capacity
endothelial function in response to Glyceryl trinitrate (GTN) as assessed by vascular ultrasound
Time frame: 4 weeks
Plan to share: No — no plan to share IPD
No publications or documents are linked to this record.
This study is status unknown, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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