Isometric Exercise Training in Participants With Heart Failure With Preserved Ejection Fraction
Primary Purpose
Heart Failure With Preserved Ejection Fraction
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Isometric exercise training
Sponsored by
About this trial
This is an interventional prevention trial for Heart Failure With Preserved Ejection Fraction focused on measuring Heart Failure, Isometric Exercise Training
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Isometric exercise training
Control group
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT05551663
First Posted
September 1, 2022
Last Updated
October 25, 2022
Sponsor
St George's, University of London
1. Study Identification
Unique Protocol Identification Number
NCT05551663
Brief Title
Isometric Exercise Training in Participants With Heart Failure With Preserved Ejection Fraction
Official Title
Isometric Exercise Training in Patients With Heart Failure With Preserved Ejection Fraction: a Randomised Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2022 (Anticipated)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St George's, University of London
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure With Preserved Ejection Fraction
Keywords
Heart Failure, Isometric Exercise Training
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Isometric exercise training
Arm Type
Experimental
Arm Title
Control group
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Isometric exercise training
Intervention Description
Participants randomised to the intervention will perform a 4-week programme of isometric exercise training.
Primary Outcome Measure Information:
Title
Diastolic function
Description
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.
Time Frame
1-year
Secondary Outcome Measure Information:
Title
Blood pressure
Description
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.
Time Frame
1-year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Isometric Exercise Training in Participants With Heart Failure With Preserved Ejection Fraction
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