Remote Ischaemic Conditioning (RIC) in Heart Failure

NCT06616233 | Unknown

• 1 other identifier: 0912
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Heart Failure With Preserved Ejection Fraction; Type 2 Diabetes; Dilated Cardiomyopathy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Brachial artery flow mediated dilation

  4 weeks

• Skeletal muscle strength

  4 weeks

• Skeletal muscle endurance

  4 weeks

• Cardiopulmonary exercise test

  4 weeks

• Brachial artery maximal dilatory capacity

  4 weeks

Study Arms (2)

Remote Ischaemic Conditioning with Exercise

EXPERIMENTAL

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

Remote Ischaemic Conditioning

OTHER

Participants will receive remote ischaemic conditioning (RIC) without exercise involving a 4-week home-based programme of RIC.

Device: Other: Remote Ischaemic Conditioning

Interventions

Remote Ischaemic Conditioning with exercise DEVICE

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.

Remote Ischaemic Conditioning with Exercise

Other: Remote Ischaemic Conditioning DEVICE

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.

Remote Ischaemic Conditioning

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Leicester: lead
• Loughborough University: collaborator

Study Sites (1)

Glenfield Hospital

Leicester, Leics, LE3 9QP, United Kingdom

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Cardiomyopathy, Dilated

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Cardiomegaly; Heart Diseases; Cardiovascular Diseases; Cardiomyopathies; Laminopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Jayanth R Arnold, BMBCh DPhil

  University of Leicester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jayanth Arnold, BMBCh DPhil

CONTACT

+44 1162583038; jra14@leicester.ac.uk

Aaron Wiseman

CONTACT

aw520@leicester.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Blinded analysis of data
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 30, 2023
• First Posted: September 27, 2024
• Study Start: April 8, 2024
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: September 27, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)