Clinical trial NCT03966417: Exercise Training After Transcatheter Aortic Valve Implantation
Official title: Exercise Training After Transcatheter Aortic Valve Implantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Valve Stenosis
TAVI
Transcatheter Aortic Valve Implantation
Rehabilitation
Keywords: exercise training
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
First posted: 2019-05-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Change of maximal oxygen uptake during exercise
timeFrame: 3 months
Secondary outcomes:
measure: Change of flow-mediated dilatation (FMD) of the brachial artery
timeFrame: 3 months
measure: Change of arterial stiffness coefficient
timeFrame: 3 months
measure: Change of value of blood N terminal-proBNP
timeFrame: 3 months
measure: Change of value of blood D-dimer
timeFrame: 3 months
measure: Change of value from-the-questionnaire-obtained quality of life
timeFrame: 3 months
measure: Change of ECG waves
timeFrame: 3 months
measure: Change in the result of the 6-minute walking test
timeFrame: 3 months
measure: Change og the heart rate variability
timeFrame: 3 months
Other outcomes:
measure: Change of heart rate recovery
timeFrame: 3 months
Locations:
city: Ljubljana
country: Slovenia
facility: UMC Ljubljana
Study officials:
affiliation: University Medical Centre Ljubljana, Slovenia
name: Borut Jug, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chakos A, Wilson-Smith A, Arora S, Nguyen TC, Dhoble A, Tarantini G, Thielmann M, Vavalle JP, Wendt D, Yan TD, Tian DH. Long term outcomes of transcatheter aortic valve implantation (TAVI): a systematic review of 5-year survival and beyond. Ann Cardiothorac Surg. 2017 Sep;6(5):432-443. doi: 10.21037/acs.2017.09.10.
citation: Pressler A, Christle JW, Lechner B, Grabs V, Haller B, Hettich I, Jochheim D, Mehilli J, Lange R, Bleiziffer S, Halle M. Exercise training improves exercise capacity and quality of life after transcatheter aortic valve implantation: A randomized pilot trial. Am Heart J. 2016 Dec;182:44-53. doi: 10.1016/j.ahj.2016.08.007. Epub 2016 Aug 26.
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citation: Voller H, Salzwedel A, Nitardy A, Buhlert H, Treszl A, Wegscheider K. Effect of cardiac rehabilitation on functional and emotional status in patients after transcatheter aortic-valve implantation. Eur J Prev Cardiol. 2015 May;22(5):568-74. doi: 10.1177/2047487314526072. Epub 2014 Feb 27.
citation: Russo N, Compostella L, Tarantini G, Setzu T, Napodano M, Bottio T, D'Onofrio A, Isabella G, Gerosa G, Iliceto S, Bellotto F. Cardiac rehabilitation after transcatheter versus surgical prosthetic valve implantation for aortic stenosis in the elderly. Eur J Prev Cardiol. 2014 Nov;21(11):1341-8. doi: 10.1177/2047487313494029. Epub 2013 Jun 11.
citation: Abraham LN, Sibilitz KL, Berg SK, Tang LH, Risom SS, Lindschou J, Taylor RS, Borregaard B, Zwisler AD. Exercise-based cardiac rehabilitation for adults after heart valve surgery. Cochrane Database Syst Rev. 2021 May 7;5(5):CD010876. doi: 10.1002/14651858.CD010876.pub3.