Dilated Cardiomyopathy, Heart Failure With Preserved Ejection Fraction, Type 2 Diabetes
Conditions
Brief summary
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
Detailed description
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.
Interventions
DEVICERemote Ischaemic Conditioning with exercise
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.
DEVICEOther: Remote Ischaemic Conditioning
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.
Sponsors
Loughborough University
University of Leicester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Blinded analysis of data
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age >18 years * Ability to provide written consent * clinical diagnosis of HFpEF (LVEF ≥50%; symptoms and signs of heart failure \[HF\] caused by a structural and/or functional abnormality, and at least one: elevated natriuretic peptides; ambulatory; BNP ≥35 pg/mL or NT-proBNP ≥125 pg/mL or hospitalised; BNP ≥100 pg/mL or NT-proBNP ≥300 pg/mL, and objective evidence of cardiogenic pulmonary or systemic congestion) OR stable type 2 diabetes (determined by formal diagnosis in hospital or GP case records with diagnostic oral glucose tolerance test or glycated haemoglobin level ≥6.5%) and with ACC/AHA stage B HF (structural disorder of the heart but no current or previous symptoms of HF) OR confirmed diagnosis of dilated cardiomyopathy
Exclusion criteria
* Absolute contraindications to MRI or contrast (e.g. severe claustrophobia, pregnancy, ferromagnetic implants, inability to lie flat, severe renal impairment eGFR<30ml/min/m2) * Moderate to severe valvular heart disease * Confirmed coronary artery disease (>50% narrowing in any major epicardial coronary artery on invasive or computed tomography coronary angiography, previous myocardial infarction, previous percutaneous intervention or coronary bypass surgery) * Known arterial stenosis of the upper extremity
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Myocardial perfusion reserve | 4 weeks | myocardial perfusion reserve under adenosine stress as assessed by quantitative cardiovascular magnetic resonance (CMR) |
| Contraction strength in the cuff deflation phase of RIC | 1 day | contraction force achieved during cuff deflation phase, measured in Newtons |
| Hyperaemic myocardial blood flow | 4 weeks | myocardial blood flow under adenosine stress as assessed by quantitative cardiovascular magnetic resonance (CMR) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Skeletal muscle endurance | 4 weeks | Isometric skeletal muscle endurance test assessed using handgrip dynamometer (sec) |
| Cardiopulmonary exercise test | 4 weeks | VO2 max for maximal aerobic capacity |
| Brachial artery maximal dilatory capacity | 4 weeks | endothelial function in response to Glyceryl trinitrate (GTN) as assessed by vascular ultrasound |
| Brachial artery flow mediated dilation | 4 weeks | endothelial function as assessed by vascular ultrasound |
| Skeletal muscle strength | 4 weeks | maximal handgrip strength (newtons) |
Countries
United Kingdom
Contacts
Primary ContactJayanth Arnold, BMBCh DPhil
Backup ContactAaron Wiseman
Outcome results
None listed