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

Heart Failure With Preserved Ejection Fraction Clinical Trial

Official title:

Isometric Exercise Training in Patients With Heart Failure With Preserved Ejection Fraction: a Randomised Controlled Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05551663
• Other study ID #: 2021.0214
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 2022
• Est. completion date: December 2023

Study information

• Verified date: October 2022
• Source: St George's, University of London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 48
• Est. completion date: December 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure With Preserved Ejection Fraction

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
St George's, University of London

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	1-year