Exercise Training After Transcatheter Aortic Valve Implantation

Not Applicable

Completed

• Conditions: Rehabilitation; TAVI; Transcatheter Aortic Valve Implantation; Aortic Valve Stenosis
• Interventions: Other: Exercise training

• Registration Number: NCT03966417
• Lead Sponsor: University Medical Centre Ljubljana

Brief Summary

In this prospective, controlled trial, patient after TAVI will be randomized to either exercise training or usual care group.

Detailed Description

Patients after transcatheter aortic valve replacement (TAVI) are particularly old and severely deconditioned and are thus likely to benefit from cardiac rehabilitation programs. In this controlled trial, patients after TAVI will be randomized to either exercise training or usual care.

The aim of our study is to compare the effect of exercise training vs. usual care on:

1. exercise capacity

2. vascular function

3. parameters of heart failure, inflammation and homeostasis

4. arrhythmogenic potential

5. health-related quality of life

Study Timeline

• Study First Submitted: 2019-05-25
• Study First Submitted QC: 2019-05-25
• Study First Posted: 2019-05-29
• Study Start: 2019-06-18
• Primary Completion: 2020-10-01
• Study Completion: 2020-12-01
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-31
• Last Update Posted: 2022-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• TAVI procedure 3-6 months prior to inclusion,
• movability (100 meters or more on 6-minute walking test after TAVI),
• ability to attend a 12 week exercise training program,
• physical and clinical ability to attend the rehabilitation program at the discretion of the researcher,
• optimal medical treatment,
• pre-signed statement of a conscious and free consent to the inclusion in the clinical trial.

Exclusion Criteria

• contraindications for exercise training,
• unstable hearth (uncontrollable heart failure - New York Heart Association stage IV, dysrhythmias, uncontrollable myocardial ischemia),
• patient's decision to undergo TAVI despite receiving a recommendation for Surgical Aortic Valve Repair by the heart team,
• non-cardiac physical impairment that would prevent exercise training on stationary bike,
• uncontrolled pulmonary disease (FEV1 <50%),
• echocardiographic signs of prosthesis dysfunction according to the Valve Academic Research Consortium (valve orifice area of b1.2 cm2 plus a mean transaortic pressure gradient of ≥20 mm Hg, or a velocity of ≥3 m/s, at least moderate paravalvular regurgitation),
• TAVI access site complication,
• important peripheral vascular disease, musculoskeletal disease or central nervous system disease, which prevents exercise training on stationary bike,
• recent (less than 3 months) acute events or illnesses that are contraindications for exercise training.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise training group	Exercise training	Patient to be randomized to "exercise training group" will have exercise training sessions 2 times per week for a period of 12 weeks. They will undergo moderate continuous exercise training at 75% of Vo2max.

Primary Outcome Measures

Name	Time	Method
Change of maximal oxygen uptake during exercise	3 months	ml/kg/min

Secondary Outcome Measures

Name	Time	Method
Change of value of blood N terminal-proBNP	3 months	ng/l
Change of arterial stiffness coefficient	3 months	coefficient
Change og the heart rate variability	3 months	Estimated with digital high-resolution ECG
Change of value of blood D-dimer	3 months	microg/l
Change of value from-the-questionnaire-obtained quality of life	3 months	points
Change in the result of the 6-minute walking test	3 months	metres
Change of ECG waves	3 months	Estimated with digital high-resolution ECG
Change of flow-mediated dilatation (FMD) of the brachial artery	3 months	% flow-mediated dilatation and arterial stiffness

Trial Locations

Locations (1)

UMC Ljubljana; 🇸🇮 Ljubljana, Slovenia