Exercise Training After Transcatheter Aortic Valve Implantation

Aortic Valve Stenosis Clinical Trial

— FitTAVI  

Official title:

Exercise Training After Transcatheter Aortic Valve Implantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03966417
• Other study ID #: UKCLFitTAVI
• Status: Completed
• Phase: N/A
• Start date: June 18, 2019
• Est. completion date: December 1, 2020

Study information

• Verified date: October 2022
• Source: University Medical Centre Ljubljana
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 1, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Rehabilitation
• TAVI
• Transcatheter Aortic Valve Implantation

Intervention

Other:
• Exercise training
Continuous exercise training 2 times per week for a period of 12 weeks.

Locations

Country	Name	City	State
Slovenia	UMC Ljubljana	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Centre Ljubljana

Country where clinical trial is conducted

Slovenia, 

References & Publications (7)

Butchart EG, Gohlke-Bärwolf C, Antunes MJ, Tornos P, De Caterina R, Cormier B, Prendergast B, Iung B, Bjornstad H, Leport C, Hall RJ, Vahanian A; Working Groups on Valvular Heart Disease, Thrombosis, and Cardiac Rehabilitation and Exercise Physiology, European Society of Cardiology. Recommendations for the management of patients after heart valve surgery. Eur Heart J. 2005 Nov;26(22):2463-71. Epub 2005 Aug 15. — View 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. Review. — View Citation

Dalal HM, Doherty P, Taylor RS. Cardiac rehabilitation. BMJ. 2015 Sep 29;351:h5000. doi: 10.1136/bmj.h5000. Review. — View Citation

McMahon SR, Ades PA, Thompson PD. The role of cardiac rehabilitation in patients with heart disease. Trends Cardiovasc Med. 2017 Aug;27(6):420-425. doi: 10.1016/j.tcm.2017.02.005. Epub 2017 Feb 15. Review. — View 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. — View 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. — View Citation

Völler 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change of heart rate recovery	beats/min	3 months
Primary	Change of maximal oxygen uptake during exercise	ml/kg/min	3 months
Secondary	Change of flow-mediated dilatation (FMD) of the brachial artery	% flow-mediated dilatation and arterial stiffness	3 months
Secondary	Change of arterial stiffness coefficient	coefficient	3 months
Secondary	Change of value of blood N terminal-proBNP	ng/l	3 months
Secondary	Change of value of blood D-dimer	microg/l	3 months
Secondary	Change of value from-the-questionnaire-obtained quality of life	points	3 months
Secondary	Change of ECG waves	Estimated with digital high-resolution ECG	3 months
Secondary	Change in the result of the 6-minute walking test	metres	3 months
Secondary	Change og the heart rate variability	Estimated with digital high-resolution ECG	3 months