Heart Failure With Preserved Ejection FractionNCT05551663
Isometric Exercise Training in Participants With Heart Failure With Preserved Ejection Fraction
A study testing Isometric exercise training in people with Heart Failure With Preserved Ejection Fraction, run by St George's, University of London.
Trial summary
Heart failure with a preserved ejection fraction (HFpEF) is a major cause of morbidity and mortality. Hypertension remains one of the major modifiable risk factors in HFpEF development and progression. 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
- What is being tested?
- Isometric exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- Nov 2022to Dec 2023
- 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
- Patients diagnosed with HFpEF.
- Patients under the care of a St George's Heart Failure cardiology consultant.
- Patients willing and able to provide informed consent.
- Male and female, aged 18 years or above.
- Medically optimised patients.
Who cannot join
- Recent myocardial infarction or electrocardiographic changes, complete heart block, unstable angina.
- Inability or unwilling to provide informed consent.
- Male and female, aged 17 years or younger.
- Patients with HFrEF.
- Patients with musculoskeletal injury that could conceivably be affected by their involvement.
- Resting BP values of ≥180/110 mmHg.
- Patients unable to understand verbal and written English.
About this study
Official title: Isometric Exercise Training in Patients With Heart Failure With Preserved Ejection Fraction: a Randomised Controlled Study
Heart failure with a preserved ejection fraction (HFpEF) is a major cause of morbidity and mortality. Hypertension remains one of the major modifiable risk factors in HFpEF development and progression. The role of aerobic exercise training for blood pressure (BP) reduction is well established, with positive cardiac, vascular, and neurohumoral adaptations all cited as potential mechanisms for improving arterial haemodynamics. However, recent evidence has shown that a specific type of resistance exercise alone, known as isometric exercise (IE), produces greater mean BP reductions than what has traditionally been seen with both aerobic and dynamic resistance exercise training programmes. Indeed, short duration IE training causes significant improvements in both cardiac structure and function, in addition to inducing significant reductions in resting BP in normotensive, pre-hypertensive and hypertensive individuals. This study aims to compare the acute and chronic effects of an IE training intervention on diastolic function parameters in patients who have been diagnosed with HFpEF compared to a control group.
- Being tested
- Isometric exercise training
- Keywords
- Heart Failure, Isometric Exercise Training
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isometric exercise trainingOther
Participants randomised to the intervention will perform a 4-week programme of isometric exercise training.
| Study group | Role | What they receive |
|---|---|---|
| Isometric exercise training | Experimental | Not described Receives: Other: Isometric exercise training |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diastolic function
Whether an isometric exercise training (IET) programme statistically significantly improves diastolic function parameters in patients who have been diagnosed with HFpEF. These parameters will be measured quantitatively using transthoracic echocardiography and using measures of transmitral filling velocity (early [E] and late [A] left ventricular filling velocities), the E/A ratio and tissue Doppler velocities (mitral annulus velocities in diastole [E']) and the E/E' ratio.
Measured: 1-year
Secondary outcomes (1)
Blood pressure
Isometric exercise training has been shown to reduce systolic and diastolic blood pressure (mmHg). Our secondary outcome measure is to record any statistically significant changes in blood pressure following a programme of isometric exercise training compared to a control group.
Measured: 1-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2022
- Study startNov 2022 (estimated)
- Primary completionSep 2023 (estimated)
- Study completionDec 2023 (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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St George's, University of London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05551663
- Sponsor's protocol ID
- 2021.0214
- Status last verified
- Oct 2022
- First submitted
- 1 Sep 2022
- Last updated
- 26 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Isometric Exercise Training in Patients With Heart Failure With Preserved Ejection Fraction: a Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT05551663
- Acronym / sponsor ID
- 2021.0214
- Keywords
- Heart Failure, Isometric Exercise Training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- St George's, University of LondonUniversity, hospital or other
- Study start
- Nov 2022 (estimated)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 23 Sep 2022 (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.
Heart failure with a preserved ejection fraction (HFpEF) is a major cause of morbidity and mortality. Hypertension remains one of the major modifiable risk factors in HFpEF development and progression. The role of aerobic exercise training for blood pressure (BP) reduction is well established, with positive cardiac, vascular, and neurohumoral adaptations all cited as potential mechanisms for improving arterial haemodynamics. However, recent evidence has shown that a specific type of resistance exercise alone, known as isometric exercise (IE), produces greater mean BP reductions than what has traditionally been seen with both aerobic and dynamic resistance exercise training programmes. Indeed, short duration IE training causes significant improvements in both cardiac structure and function, in addition to inducing significant reductions in resting BP in normotensive, pre-hypertensive and hypertensive individuals. This study aims to compare the acute and chronic effects of an IE training intervention on diastolic function parameters in patients who have been diagnosed with HFpEF compared to a control group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Isometric exercise training | Experimental | Other: Isometric exercise training |
| Control group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients diagnosed with HFpEF.
- Patients under the care of a St George's Heart Failure cardiology consultant.
- Patients willing and able to provide informed consent.
- Male and female, aged 18 years or above.
- Medically optimised patients.
Key exclusion criteria (7 listed)
- Recent myocardial infarction or electrocardiographic changes, complete heart block, unstable angina.
- Inability or unwilling to provide informed consent.
- Male and female, aged 17 years or younger.
- Patients with HFrEF.
- Patients with musculoskeletal injury that could conceivably be affected by their involvement.
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 |
|---|---|---|
| Isometric exercise trainingParticipants randomised to the intervention will perform a 4-week programme of isometric exercise training. | Other | Isometric exercise training |
Primary outcome
Diastolic function
Time frame: 1-year
Whether an isometric exercise training (IET) programme statistically significantly improves diastolic function parameters in patients who have been diagnosed with HFpEF. These parameters will be measured quantitatively using transthoracic echocardiography and using measures of transmitral filling velocity (early [E] and late [A] left ventricular filling velocities), the E/A ratio and tissue Doppler velocities (mitral annulus velocities in diastole [E']) and the E/E' ratio.
1 secondary outcome
Blood pressure
Time frame: 1-year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2022.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Isometric exercise training in people with Heart Failure With Preserved Ejection Fraction, run by St George's, University of London.
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 5 inclusion and 7 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 26 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diastolic function (time frame: 1-year). 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 26 Oct 2022.