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| Name | Class |
|---|---|
| Loughborough University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remote Ischaemic Conditioning with Exercise | Experimental | 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. |
|
| Remote Ischaemic Conditioning | Other | Participants will receive remote ischaemic conditioning (RIC) without exercise involving a 4-week home-based programme of RIC. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remote Ischaemic Conditioning with exercise | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Myocardial perfusion reserve | myocardial perfusion reserve under adenosine stress as assessed by quantitative cardiovascular magnetic resonance (CMR) | 4 weeks |
| Contraction strength in the cuff deflation phase of RIC | contraction force achieved during cuff deflation phase, measured in Newtons | 1 day |
| Hyperaemic myocardial blood flow | myocardial blood flow under adenosine stress as assessed by quantitative cardiovascular magnetic resonance (CMR) | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Brachial artery flow mediated dilation | endothelial function as assessed by vascular ultrasound | 4 weeks |
| Skeletal muscle strength | maximal handgrip strength (newtons) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jayanth Arnold, BMBCh DPhil | Contact | +44 1162583038 | jra14@leicester.ac.uk | |
| Aaron Wiseman | Contact | aw520@leicester.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Jayanth R Arnold, BMBCh DPhil | University of Leicester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Glenfield Hospital | Recruiting | Leicester | Leics | LE3 9QP | United Kingdom |
no plan to share IPD
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D002311 | Cardiomyopathy, Dilated |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
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Randomised trial of the effect of remote ischemic conditioning with or without lower intensity exercise on hyperaemic myocardial blood flow in patients with or at risk of heart failure.
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Blinded analysis of data
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|
| Other: Remote Ischaemic Conditioning | Device | 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. |
|
| 4 weeks |
| Skeletal muscle endurance | Isometric skeletal muscle endurance test assessed using handgrip dynamometer (sec) | 4 weeks |
| Cardiopulmonary exercise test | VO2 max for maximal aerobic capacity | 4 weeks |
| Brachial artery maximal dilatory capacity | endothelial function in response to Glyceryl trinitrate (GTN) as assessed by vascular ultrasound | 4 weeks |
| D004700 | Endocrine System Diseases |
| D006332 | Cardiomegaly |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D009202 | Cardiomyopathies |
| D000083083 | Laminopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D013812 |
| Therapeutics |
| D026741 | Physical Therapy Modalities |