Heart Failure With Preserved Ejection FractionENRICHNCT06616233
Remote Ischaemic Conditioning (RIC) in Heart Failure
A study testing Remote Ischaemic Conditioning with exercise and Other: Remote Ischaemic Conditioning in people with Heart Failure With Preserved Ejection Fraction and Type 2 Diabetes, run by University of Leicester at 1 site in United Kingdom.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure With Preserved Ejection Fraction, Type 2 Diabetes, Dilated Cardiomyopathy
- What is being tested?
- Remote Ischaemic Conditioning with exercise and Other: Remote Ischaemic Conditioning
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 Apr 2024to Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Aaron Wiseman contact
United Kingdom1 site, 1 recruiting
- Recruiting
Glenfield Hospital
Leicester, Leics, LE3 9QP
Jayanth Arnold, 01162583038, jra14@le.ac.uk
About this study
Official title: 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
Read the 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.
- Being tested
- Remote Ischaemic Conditioning with exercise, Other: Remote Ischaemic Conditioning
- Medical subject headings
- Diabetes Mellitus, Type 2, Cardiomyopathy, Dilated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Other: Remote Ischaemic Conditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial perfusion reserve
myocardial perfusion reserve under adenosine stress as assessed by quantitative cardiovascular magnetic resonance (CMR)
Measured: 4 weeks
Contraction strength in the cuff deflation phase of RIC
contraction force achieved during cuff deflation phase, measured in Newtons
Measured: 1 day
Hyperaemic myocardial blood flow
myocardial blood flow under adenosine stress as assessed by quantitative cardiovascular magnetic resonance (CMR)
Measured: 4 weeks
Secondary outcomes (5)
Brachial artery flow mediated dilation
endothelial function as assessed by vascular ultrasound
Measured: 4 weeks
Skeletal muscle strength
maximal handgrip strength (newtons)
Measured: 4 weeks
Skeletal muscle endurance
Isometric skeletal muscle endurance test assessed using handgrip dynamometer (sec)
Measured: 4 weeks
Cardiopulmonary exercise test
VO2 max for maximal aerobic capacity
Measured: 4 weeks
Brachial artery maximal dilatory capacity
endothelial function in response to Glyceryl trinitrate (GTN) as assessed by vascular ultrasound
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2024
- Study start8 Apr 2024
- Primary completionOct 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Preserved Ejection FractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leicester
- Sponsor type
- University, hospital or other
- Collaborators
- Loughborough University
- Responsible party
- Sponsor
- Investigators
- Jayanth R Arnold, BMBCh DPhil, Principal investigator, University of Leicester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06616233
- Sponsor's protocol ID
- 0912
- Acronym
- ENRICH
- Status last verified
- Nov 2023
- First submitted
- 30 Nov 2023
- Last updated
- 27 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no plan to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Chronic Remote Ischaemic Conditioning on Coronary and Peripheral Vascular Function in Patients With Heart Failure
- ClinicalTrials.gov ID
- NCT06616233
- Acronym / sponsor ID
- ENRICH / 0912
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of LeicesterUniversity, hospital or other
- Collaborators
- Loughborough University
- Study start
- 8 Apr 2024 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 27 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Remote Ischaemic Conditioning with Exercise | Experimental | Device: Remote Ischaemic Conditioning with exerciseParticipants 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. |
| Remote Ischaemic Conditioning | Other | Device: Other: Remote Ischaemic ConditioningParticipants will receive remote ischaemic conditioning (RIC) without exercise involving a 4-week home-based programme of RIC. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote Ischaemic Conditioning with exerciseParticipants 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. | Device | Remote Ischaemic Conditioning with Exercise |
| Other: Remote Ischaemic ConditioningParticipants 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. | Device | Remote Ischaemic Conditioning |
Primary outcome
Myocardial perfusion reserve
Time frame: 4 weeks
myocardial perfusion reserve under adenosine stress as assessed by quantitative cardiovascular magnetic resonance (CMR)
Contraction strength in the cuff deflation phase of RIC
Time frame: 1 day
contraction force achieved during cuff deflation phase, measured in Newtons
Hyperaemic myocardial blood flow
Time frame: 4 weeks
myocardial blood flow under adenosine stress as assessed by quantitative cardiovascular magnetic resonance (CMR)
5 secondary outcomes
Brachial artery flow mediated dilation
Time frame: 4 weeks
Skeletal muscle strength
Time frame: 4 weeks
Skeletal muscle endurance
Time frame: 4 weeks
Cardiopulmonary exercise test
Time frame: 4 weeks
Brachial artery maximal dilatory capacity
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2024.
- Individual participant dataSharing planned: No. no plan to share IPD
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Maridebart Cafraglutide in Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Obesity
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aaron Wiseman contact
Jayanth R Arnold, BMBCh DPhil principal investigator
University of Leicester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote Ischaemic Conditioning with exercise and Other: Remote Ischaemic Conditioning in people with Heart Failure With Preserved Ejection Fraction and Type 2 Diabetes, run by University of Leicester at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jayanth Arnold, BMBCh DPhil (+44 1162583038, jra14@leicester.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myocardial perfusion reserve (time frame: 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2024.