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出境医 / 临床实验 / Exercise Training After Transcatheter Aortic Valve Implantation (FitTAVI)

Exercise Training After Transcatheter Aortic Valve Implantation (FitTAVI)

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

Condition or disease Intervention/treatment Phase
Aortic Valve Stenosis TAVI Transcatheter Aortic Valve Implantation Rehabilitation Other: Exercise training Not Applicable

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
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Exercise Training After Transcatheter Aortic Valve Implantation
Actual Study Start Date : June 18, 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : December 2020
Arms and Interventions
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.
 Other: Exercise training
Continuous exercise training 2 times per week for a period of 12 weeks.
Other Name: Rehabilitation
No Intervention: Usual care group
Patient to be randomized to "usual care group" will undergo standard care fo 12 weeks.
Outcome Measures
Primary Outcome Measures :
  1. Change of maximal oxygen uptake during exercise [ Time Frame: 3 months ]
    ml/kg/min


Secondary Outcome Measures :
  1. Change of flow-mediated dilatation (FMD) of the brachial artery [ Time Frame: 3 months ]
    % flow-mediated dilatation and arterial stiffness

  2. Change of arterial stiffness coefficient [ Time Frame: 3 months ]
    coefficient

  3. Change of value of blood N terminal-proBNP [ Time Frame: 3 months ]
    ng/l

  4. Change of value of blood D-dimer [ Time Frame: 3 months ]
    microg/l

  5. Change of value from-the-questionnaire-obtained quality of life [ Time Frame: 3 months ]
    points

  6. Change of ECG waves [ Time Frame: 3 months ]
    Estimated with digital high-resolution ECG

  7. Change in the result of the 6-minute walking test [ Time Frame: 3 months ]
    metres

  8. Change og the heart rate variability [ Time Frame: 3 months ]
    Estimated with digital high-resolution ECG


Other Outcome Measures:
  1. Change of heart rate recovery [ Time Frame: 3 months ]
    beats/min


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Luka Vitez, MD +38641951672 luka.vitez@gmail.com
Contact: Borut Jug, MD, PhD borut.jug@kclj.si

Locations
Layout table for location information
Slovenia
UMC Ljubljana Recruiting
Ljubljana, Slovenia, 1000
Contact: Borut Jug, PhD       borut.jug@kclj.si   
Principal Investigator: Luka Vitez, MD         
Sponsors and Collaborators
University Medical Centre Ljubljana
Investigators
Layout table for investigator information
Principal Investigator: Borut Jug, MD, PhD University Medical Centre Ljubljana, Slovenia
Tracking Information
First Submitted Date  ICMJE May 25, 2019
First Posted Date  ICMJE May 29, 2019
Last Update Posted Date June 19, 2019
Actual Study Start Date  ICMJE June 18, 2019
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 25, 2019) 		Change of maximal oxygen uptake during exercise [ Time Frame: 3 months ]
ml/kg/min
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 25, 2019)
  • Change of flow-mediated dilatation (FMD) of the brachial artery [ Time Frame: 3 months ]
    % flow-mediated dilatation and arterial stiffness
  • Change of arterial stiffness coefficient [ Time Frame: 3 months ]
    coefficient
  • Change of value of blood N terminal-proBNP [ Time Frame: 3 months ]
    ng/l
  • Change of value of blood D-dimer [ Time Frame: 3 months ]
    microg/l
  • Change of value from-the-questionnaire-obtained quality of life [ Time Frame: 3 months ]
    points
  • Change of ECG waves [ Time Frame: 3 months ]
    Estimated with digital high-resolution ECG
  • Change in the result of the 6-minute walking test [ Time Frame: 3 months ]
    metres
  • Change og the heart rate variability [ Time Frame: 3 months ]
    Estimated with digital high-resolution ECG
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 25, 2019) 		Change of heart rate recovery [ Time Frame: 3 months ]
beats/min
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Exercise Training After Transcatheter Aortic Valve Implantation
Official Title  ICMJE Exercise Training After Transcatheter Aortic Valve Implantation
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Aortic Valve Stenosis
  • TAVI
  • Transcatheter Aortic Valve Implantation
  • Rehabilitation
Intervention  ICMJE Other: Exercise training
Continuous exercise training 2 times per week for a period of 12 weeks.
Other Name: Rehabilitation
Study Arms  ICMJE
  • 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.
    Intervention: Other: Exercise training
  • No Intervention: Usual care group
    Patient to be randomized to "usual care group" will undergo standard care fo 12 weeks.
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. Review.
  • 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.
  • Dalal HM, Doherty P, Taylor RS. Cardiac rehabilitation. BMJ. 2015 Sep 29;351:h5000. doi: 10.1136/bmj.h5000. Review.
  • 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.
  • 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.
  • 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.
  • 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:CD010876. doi: 10.1002/14651858.CD010876.pub3. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 25, 2019) 		40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Slovenia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03966417
Other Study ID Numbers  ICMJE UKCLFitTAVI
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Borut Jug, University Medical Centre Ljubljana
Study Sponsor  ICMJE University Medical Centre Ljubljana
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Borut Jug, MD, PhD University Medical Centre Ljubljana, Slovenia
PRS Account University Medical Centre Ljubljana
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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