- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03966417
Exercise Training After Transcatheter Aortic Valve Implantation (FitTAVI)
October 31, 2022 updated by: Borut Jug, University Medical Centre Ljubljana
In this prospective, controlled trial, patient after TAVI will be randomized to either exercise training or usual care group.
Study Overview
Status
Completed
Intervention / Treatment
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:
- exercise capacity
- vascular function
- parameters of heart failure, inflammation and homeostasis
- arrhythmogenic potential
- health-related quality of life
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Ljubljana, Slovenia, 1000
- UMC Ljubljana
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 99 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Exercise training group
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.
|
Continuous exercise training 2 times per week for a period of 12 weeks.
Other Names:
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No Intervention: Usual care group
Patient to be randomized to "usual care group" will undergo standard care fo 12 weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of maximal oxygen uptake during exercise
Time Frame: 3 months
|
ml/kg/min
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of flow-mediated dilatation (FMD) of the brachial artery
Time Frame: 3 months
|
% flow-mediated dilatation and arterial stiffness
|
3 months
|
Change of arterial stiffness coefficient
Time Frame: 3 months
|
coefficient
|
3 months
|
Change of value of blood N terminal-proBNP
Time Frame: 3 months
|
ng/l
|
3 months
|
Change of value of blood D-dimer
Time Frame: 3 months
|
microg/l
|
3 months
|
Change of value from-the-questionnaire-obtained quality of life
Time Frame: 3 months
|
points
|
3 months
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Change of ECG waves
Time Frame: 3 months
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Estimated with digital high-resolution ECG
|
3 months
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Change in the result of the 6-minute walking test
Time Frame: 3 months
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metres
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3 months
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Change og the heart rate variability
Time Frame: 3 months
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Estimated with digital high-resolution ECG
|
3 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of heart rate recovery
Time Frame: 3 months
|
beats/min
|
3 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Borut Jug, MD, PhD, University Medical Centre Ljubljana, Slovenia
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Dalal HM, Doherty P, Taylor RS. Cardiac rehabilitation. BMJ. 2015 Sep 29;351:h5000. doi: 10.1136/bmj.h5000. No abstract available.
- 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.
- 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.
- 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.
- Butchart EG, Gohlke-Barwolf 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. doi: 10.1093/eurheartj/ehi426. Epub 2005 Aug 15.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 18, 2019
Primary Completion (Actual)
October 1, 2020
Study Completion (Actual)
December 1, 2020
Study Registration Dates
First Submitted
May 25, 2019
First Submitted That Met QC Criteria
May 25, 2019
First Posted (Actual)
May 29, 2019
Study Record Updates
Last Update Posted (Actual)
November 1, 2022
Last Update Submitted That Met QC Criteria
October 31, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UKCLFitTAVI
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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