Remote Ischaemic Conditioning (RIC) in Heart Failure (ENRICH)

Effects of Chronic Remote Ischaemic Conditioning on Coronary and Peripheral Vascular Function in Patients With Heart Failure

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

Study Overview

• Status: Recruiting
• Conditions: Type 2 Diabetes; Dilated Cardiomyopathy; Heart Failure With Preserved Ejection Fraction
• Intervention / Treatment: Device: Remote Ischaemic Conditioning with exercise; Device: Other: Remote Ischaemic Conditioning

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jayanth Arnold, BMBCh DPhil; Phone Number: +44 1162583038; Email: jra14@leicester.ac.uk
• Study Contact Backup: Name: Aaron Wiseman; Email: aw520@leicester.ac.uk

Study Locations

• United Kingdom
  • Leics
    • Leicester, Leics, United Kingdom, LE3 9QP
      • Recruiting
      • Glenfield Hospital
      • Contact: Jayanth Arnold; Phone Number: 01162583038; Email: jra14@le.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Remote Ischaemic Conditioning with Exercise; 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.	Device: Remote 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.
Other: Remote Ischaemic Conditioning; Participants will receive remote ischaemic conditioning (RIC) without exercise involving a 4-week home-based programme of RIC.	Device: Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: University of Leicester
• Collaborators: Loughborough University
• Investigators: Principal Investigator: Jayanth R Arnold, BMBCh DPhil, University of Leicester

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2024
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: November 30, 2023
• First Submitted That Met QC Criteria: September 23, 2024
• First Posted (Actual): September 27, 2024

Study Record Updates

• Last Update Posted (Actual): September 27, 2024
• Last Update Submitted That Met QC Criteria: September 23, 2024
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Genetic Diseases, Inborn; Cardiomegaly; Laminopathies; Heart Failure; Cardiomyopathies; Cardiomyopathy, Dilated
• Other Study ID Numbers: 0912

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: no plan to share IPD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No