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Exercise Training After Transcatheter Aortic Valve Implantation (FitTAVI)

Primary Purpose

Aortic Valve Stenosis, TAVI, Transcatheter Aortic Valve Implantation

Status
Completed
Phase
Not Applicable
Locations
Slovenia
Study Type
Interventional
Intervention
Exercise training
Sponsored by
University Medical Centre Ljubljana
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Valve Stenosis focused on measuring exercise training

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UMC Ljubljana

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Exercise training group

Usual care group

Arm Description

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.

Patient to be randomized to "usual care group" will undergo standard care fo 12 weeks.

Outcomes

Primary Outcome Measures

Change of maximal oxygen uptake during exercise
ml/kg/min

Secondary Outcome Measures

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

Full Information

First Posted
May 25, 2019
Last Updated
October 31, 2022
Sponsor
University Medical Centre Ljubljana
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1. Study Identification

Unique Protocol Identification Number
NCT03966417
Brief Title
Exercise Training After Transcatheter Aortic Valve Implantation
Acronym
FitTAVI
Official Title
Exercise Training After Transcatheter Aortic Valve Implantation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
June 18, 2019 (Actual)
Primary Completion Date
October 1, 2020 (Actual)
Study Completion Date
December 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Centre Ljubljana

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: exercise capacity vascular function parameters of heart failure, inflammation and homeostasis arrhythmogenic potential health-related quality of life

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Valve Stenosis, TAVI, Transcatheter Aortic Valve Implantation, Rehabilitation
Keywords
exercise training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise training group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Usual care group
Arm Type
No Intervention
Arm Description
Patient to be randomized to "usual care group" will undergo standard care fo 12 weeks.
Intervention Type
Other
Intervention Name(s)
Exercise training
Other Intervention Name(s)
Rehabilitation
Intervention Description
Continuous exercise training 2 times per week for a period of 12 weeks.
Primary Outcome Measure Information:
Title
Change of maximal oxygen uptake during exercise
Description
ml/kg/min
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Change of flow-mediated dilatation (FMD) of the brachial artery
Description
% flow-mediated dilatation and arterial stiffness
Time Frame
3 months
Title
Change of arterial stiffness coefficient
Description
coefficient
Time Frame
3 months
Title
Change of value of blood N terminal-proBNP
Description
ng/l
Time Frame
3 months
Title
Change of value of blood D-dimer
Description
microg/l
Time Frame
3 months
Title
Change of value from-the-questionnaire-obtained quality of life
Description
points
Time Frame
3 months
Title
Change of ECG waves
Description
Estimated with digital high-resolution ECG
Time Frame
3 months
Title
Change in the result of the 6-minute walking test
Description
metres
Time Frame
3 months
Title
Change og the heart rate variability
Description
Estimated with digital high-resolution ECG
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
Change of heart rate recovery
Description
beats/min
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Borut Jug, MD, PhD
Organizational Affiliation
University Medical Centre Ljubljana, Slovenia
Official's Role
Principal Investigator
Facility Information:
Facility Name
UMC Ljubljana
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29062738
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.
Results Reference
background
PubMed Identifier
27914499
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.
Results Reference
background
PubMed Identifier
26419744
Citation
Dalal HM, Doherty P, Taylor RS. Cardiac rehabilitation. BMJ. 2015 Sep 29;351:h5000. doi: 10.1136/bmj.h5000. No abstract available.
Results Reference
background
PubMed Identifier
28318815
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.
Results Reference
background
PubMed Identifier
16103039
Citation
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.
Results Reference
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PubMed Identifier
24577878
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.
Results Reference
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PubMed Identifier
23757283
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.
Results Reference
background
PubMed Identifier
33962483
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.
Results Reference
derived

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Exercise Training After Transcatheter Aortic Valve Implantation

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