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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
St George's, University of London
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    September 1, 2022
    Last Updated
    October 25, 2022
    Sponsor
    St George's, University of London
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    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

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    Isometric Exercise Training in Participants With Heart Failure With Preserved Ejection Fraction

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