Aortic Valve StenosisFitTAVINCT03966417
Exercise Training After Transcatheter Aortic Valve Implantation
A study testing Exercise training in people with Aortic Valve Stenosis and TAVI, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial summary
In this prospective, controlled trial, patient after TAVI will be randomized to either exercise training or usual care group. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Aortic Valve Stenosis, TAVI, Transcatheter Aortic Valve Implantation
- What is being tested?
- Exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSlovenia
- Study dates
- 18 Jun 2019to 1 Dec 2020
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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),
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
In this prospective, controlled trial, patient after TAVI will be randomized to either exercise training or usual care group.
Read the 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
- Being tested
- Exercise training
- Keywords
- exercise training
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise trainingOther
Also called Rehabilitation
Continuous exercise training 2 times per week for a period of 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Exercise training group | Active comparator | 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. Receives: Other: Exercise training |
| Usual care group | No intervention | Patient to be randomized to "usual care group" will undergo standard care fo 12 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of maximal oxygen uptake during exercise
ml/kg/min
Measured: 3 months
Secondary outcomes (8)
Change of flow-mediated dilatation (FMD) of the brachial artery
% flow-mediated dilatation and arterial stiffness
Measured: 3 months
Change of arterial stiffness coefficient
coefficient
Measured: 3 months
Change of value of blood N terminal-proBNP
ng/l
Measured: 3 months
Change of value of blood D-dimer
microg/l
Measured: 3 months
Change of value from-the-questionnaire-obtained quality of life
points
Measured: 3 months
Change of ECG waves
Estimated with digital high-resolution ECG
Measured: 3 months
Change in the result of the 6-minute walking test
metres
Measured: 3 months
Change og the heart rate variability
Estimated with digital high-resolution ECG
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2019
- Study start18 Jun 2019
- Primary completion1 Oct 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Borut Jug, University Medical Centre Ljubljana
- Investigators
- Borut Jug, MD, PhD, Principal investigator, University Medical Centre Ljubljana, Slovenia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03966417
- Sponsor's protocol ID
- UKCLFitTAVI
- Acronym
- FitTAVI
- Status last verified
- Oct 2022
- First submitted
- 25 May 2019
- Last updated
- 1 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29062738Pressler 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.
PubMed 27914499Dalal HM, Doherty P, Taylor RS. Cardiac rehabilitation. BMJ. 2015 Sep 29;351:h5000. doi: 10.1136/bmj.h5000. No abstract available.
PubMed 26419744McMahon 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.
PubMed 28318815Butchart 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.
PubMed 16103039Voller 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.
PubMed 24577878Russo 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.
PubMed 23757283Abraham 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.
PubMed 33962483