Clinical trial NCT06616233: Remote Ischaemic Conditioning (RIC) in Heart Failure
Official title: Effects of Chronic Remote Ischaemic Conditioning on Coronary and Peripheral Vascular Function in Patients With Heart Failure
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure With Preserved Ejection Fraction
Type 2 Diabetes
Dilated Cardiomyopathy
Lead sponsor: University of Leicester
Sponsor class: OTHER
Collaborators: name: Loughborough University
First posted: 2024-09-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Age \&gt;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\&lt;30ml/min/m2)
* Moderate to severe valvular heart disease
* Confirmed coronary artery disease (\&gt;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

Primary outcomes:
measure: Myocardial perfusion reserve
timeFrame: 4 weeks
measure: Contraction strength in the cuff deflation phase of RIC
timeFrame: 1 day
measure: Hyperaemic myocardial blood flow
timeFrame: 4 weeks
Secondary outcomes:
measure: Brachial artery flow mediated dilation
timeFrame: 4 weeks
measure: Skeletal muscle strength
timeFrame: 4 weeks
measure: Skeletal muscle endurance
timeFrame: 4 weeks
measure: Cardiopulmonary exercise test
timeFrame: 4 weeks
measure: Brachial artery maximal dilatory capacity
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Leicester
country: United Kingdom
facility: Glenfield Hospital
state: Leics
Study officials:
affiliation: University of Leicester
name: Jayanth R Arnold, BMBCh DPhil
role: PRINCIPAL_INVESTIGATOR
References: