Remote Ischaemic Conditioning (RIC) in Heart Failure

University of Leicester60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Heart Failure With Preserved Ejection Fraction Type 2 Diabetes Dilated Cardiomyopathy

Interventions

Remote Ischaemic Conditioning with exerciseDEVICE

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.

Other: Remote Ischaemic ConditioningDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Glenfield Hospital

Leicester, Leics, United Kingdom

RECRUITING

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Central Contacts

Jayanth Arnold, BMBCh DPhil

CONTACT

+44 1162583038 jra14@leicester.ac.uk

Aaron Wiseman

CONTACT

aw520@leicester.ac.uk

Data from ClinicalTrials.gov

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