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

NCT05551663 | Unknown DMC

• 1 other identifier: 2021.0214
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Heart Failure With Preserved Ejection Fraction

Keywords

Heart Failure; Isometric Exercise Training

Outcome Measures

Primary Outcomes (1)

• 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.

  1-year

Secondary Outcomes (1)

• Blood pressure

  1-year

Study Arms (2)

Isometric exercise training

EXPERIMENTAL

Other: Isometric exercise training

Control group

NO INTERVENTION

Interventions

Isometric exercise training OTHER

Participants randomised to the intervention will perform a 4-week programme of isometric exercise training.

Isometric exercise training

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• St George's, University of London: lead

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2022
• First Posted: September 23, 2022
• Study Start: November 1, 2022
• Primary Completion: September 1, 2023
• Study Completion: December 1, 2023
• Last Updated: October 26, 2022

Record last verified: 2022-10