Using remote ischaemic conditioning to improve heart function in heart failure patients
Effects of Chronic Remote Ischaemic Conditioning on Coronary and Peripheral Vascular Function in Patients With Heart Failure
NA · University of Leicester · NCT06616233
This study is testing if a new method that combines a special arm cuff treatment with light exercises can help improve heart function in people with heart failure or those at risk for it.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Leicester (other) |
| Locations | 1 site (Leicester, Leics) |
| Trial ID | NCT06616233 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of remote ischaemic conditioning (RIC) combined with exercise on heart blood flow in patients with heart failure or at risk of developing it. The approach involves inflating a cuff on the arm to temporarily reduce blood flow, which may release beneficial chemicals into the bloodstream that improve heart function. The study aims to determine if this method, when paired with light arm exercises, can enhance blood vessel and heart health. It is a single-centre prospective study conducted at Glenfield Hospital in Leicester.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with heart failure with preserved ejection fraction, stable type 2 diabetes, or dilated cardiomyopathy.
Not a fit: Patients with severe claustrophobia, pregnancy, or severe renal impairment may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve heart function and quality of life for patients with heart failure.
How similar studies have performed: While RIC has shown promise in other heart disease contexts, its application in heart failure is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Leicester, Leics
- Glenfield Hospital — Leicester, Leics, United Kingdom (RECRUITING)
Study contacts
- Principal investigator: Jayanth R Arnold, BMBCh DPhil — University of Leicester
- Study coordinator: Jayanth Arnold, BMBCh DPhil
- Email: jra14@leicester.ac.uk
- Phone: +44 1162583038
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Heart Failure With Preserved Ejection Fraction, Type 2 Diabetes, Dilated Cardiomyopathy