The CardioFit Trial: Exercise Training Before Aortic Valve Surgery

Not Applicable

Active, not recruiting

• Conditions: Aortic Stenosis, Severe

• Registration Number: NCT06818110
• Lead Sponsor: University Hospital Southampton NHS Foundation Trust

Brief Summary

The CardioFit Trial: The feasibility, safety and tolerability of an exercise training programme in patients with severe aortic stenosis prior to aortic valve replacement surgery: A feasibility trial To investigate if a Structured Responsive Exercise Training Programme (SRETP) delivered before aortic valve replacement (AVR) in patients with severe aortic stenosis is feasible, safe, and tolerable.

Fitter patients have better surgical outcomes. Exercising post AVR surgery has been well documented and supported through cardiac rehabilitation programmes. However, there is limited evidence investigating exercising patients preoperatively, in part related to safety considerations in patients with severe aortic stenosis. If undertaking a SRETP before AVR in patients with severe aortic stenosis is shown to be feasible and safe, it provides a prehabilitation opportunity to enhance physical fitness with the aim of improving surgical outcomes.

Therefore, this trial will investigate whether SRETP (Prehabilitation) delivered before AVR in patients with severe aortic stenosis is safe \& feasible.

Detailed Description

Single-centre Feasibility trial 15 patients

* Age ≥ 18 years old

* Severe aortic stenosis with a multidisciplinary team (MDT) plan for elective, aortic valve replacement

* At least 14 days until planned to come in (TCI) date

* Diagnosis of critical aortic stenosis defined as a mean gradient of ≥60mmHg or Vmax ≥5 m/s

* Presyncope/syncope due to aortic stenosis

* Unstable angina/indication for urgent surgery

* Malignant arrhythmias

* Known pregnancy

* Patients declining surgery

* Patients weight exceeds 160kg

* Patients unable to give informed consent

Intervention: 1) An in-hospital Structured Responsive Exercise-Training Programme (SRETP). The intervention will be delivered before surgery.

Feasibility Outcomes:

1. Adherence to the intervention of ≥75%

2. Tolerability of the intervention (minutes completed during the interval training) of ≥75%

3. Adverse Events to SRETP

* Currently participating in another interventional clinical trial (this will be reviewed on a case-by-case basis)

Contraindications to SRETP:

* Acute systemic illness or fever

* Uncontrolled atrial or ventricular arrhythmias

* Uncontrolled sinus tachycardia (heart rate \>120bpm)

* Acute pericarditis or myocarditis

* Decompensated heart failure

* Second or Third degree (complete) atrioventricular block without pacemaker

* Recent pulmonary embolism or deep vein thrombosis within 2 weeks

* Patients are unable to perform CPET (e.g. severe musculoskeletal conditions)

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-27
• Study Start: 2025-01-28
• Study First Submitted QC: 2025-02-05
• Last Update Submitted: 2025-02-05
• Study First Posted: 2025-02-10
• Last Update Posted: 2025-02-10
• Primary Completion: 2025-10-10
• Study Completion: 2025-12-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

4.1. INCLUSION CRITERIA

Participants may enter the study if ALL of the following apply:

• Age ≥ 18 years old
• Severe aortic stenosis with a multidisciplinary team (MDT) plan for elective, aortic valve replacement
• At least 14 days until planned to come in (TCI) date.

Exclusion Criteria

4.2. EXCLUSION CRITERIA

• Diagnosis of critical aortic stenosis defined as a mean gradient of ≥60mmHg or Vmax ≥5 m/s
• Presyncope/syncope due to aortic stenosis
• Unstable angina/indication for urgent surgery
• Malignant arrhythmias
• Known pregnancy
• Patients declining surgery
• Patients weight exceeds 160kg
• Patients unable to give informed consent
• Currently participating in another interventional clinical trial (although this will be reviewed on a case-by-case basis)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Feasibility Outcomes	Baseline up to surgery	1. Adherence to the intervention ≥75%; 2. Tolerability of the intervention (minutes completed during the interval training) of ≥75%; 3. Adverse Events to the intervention (defined as occurring during or up to 30-minutes post exercise training)

Secondary Outcome Measures

Name	Time	Method
Endurance time	Baseline up to surgery	Change in time to limit of tolerance (endurance time) as measured by a constant work-rate exercise test
Change in objectively measured cardiopulmonary exercise testing variables	Baseline up to surgery	Measure a change in cardiopulmonary exercise variables. These include but are not limited to: Oxygen uptake (VO2) at anaerobic threshold (AT); Oxygen uptake at peak exercise; VE/VCO2 slope; Oxygen pulse
Health-related quality of life	Baseline up to surgery	Changes in health related quality of life measurements using validated questionnaires including: EQ-5D-5L: A standardised measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal; Toronto Aortic Stenosis Quality of Life Questionnaire (TASQ-Q): A validated, brief, self-administered tool to measure changes in quality of life in patients with aortic stenosis undergoing an intervention.

Trial Locations

Locations (1)

University Hopsitals Southampton NHS FT; 🇬🇧 Southampton, United Kingdom