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Assessment and Cardiovascular Rehabilitation in Patients With Severe Aortic Stenosis

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ClinicalTrials.gov Identifier: NCT02468219
Recruitment Status : Active, not recruiting
First Posted : June 10, 2015
Last Update Posted : March 7, 2018
Sponsor:
Collaborator:
Federal University of Health Science of Porto Alegre
Information provided by (Responsible Party):
Marlus Karsten, Federal University of Health Science of Porto Alegre

Brief Summary:
This study will evaluate hemodynamic and functional changes resulting from valve intervention in patients with severe aortic stenosis undergoing valve replacement (AVR) or transcatheter aortic valve implantation (TAVI), and their influence on the pathophysiological mechanisms involved in cardiovascular rehabilitation.

Condition or disease Intervention/treatment Phase
Aortic Valve Stenosis Behavioral: cardiovascular rehabilitation program Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Multiparametric Assessment and Cardiovascular Rehabilitation in Patients With Severe Aortic Stenosis Undergoing Valve Surgery: Effects on Hemodynamics, Functional Capacity, Frailty, Prognosis and Quality of Life
Study Start Date : March 31, 2015
Actual Primary Completion Date : June 2017
Estimated Study Completion Date : July 2021


Arm Intervention/treatment
Active Comparator: aortic valve replacement
patients with aortic stenosis submitted to aortic valve replacement procedure
Behavioral: cardiovascular rehabilitation program

Phase I - respiratory muscle training and neuromuscular electrical stimulation 7x/week for 6 weeks.

Phase II - 8 weeks of supervised, structured, combined endurance and resistance training.


Experimental: transcatheter aortic valve implantation
patients with aortic stenosis who underwent to transcatheter aortic valve implantation
Behavioral: cardiovascular rehabilitation program

Phase I - respiratory muscle training and neuromuscular electrical stimulation 7x/week for 6 weeks.

Phase II - 8 weeks of supervised, structured, combined endurance and resistance training.





Primary Outcome Measures :
  1. Functional Capacity by the Six-Minute Walk Test [ Time Frame: Change from Baseline at 3, 6 and 12 months ]

Secondary Outcome Measures :
  1. Endothelium Function by the Reactive Hyperemia Index [ Time Frame: Change from Baseline at 3, 6 and 12 months ]
  2. Autonomic Modulation by the Heart Rate Variability [ Time Frame: Change from Baseline at 3, 6 and 12 months ]
  3. Cardiac Output by the Impedance Cardiography [ Time Frame: Change from Baseline at 3, 6 and 12 months ]
  4. Frailty by Cardiovascular Health Study Index [ Time Frame: Change from Baseline at 3, 6 and 12 months ]
  5. Quality of Life by the Minnesota Living with Heart Failure Questionnaire [ Time Frame: Change from Baseline at 3, 6 and 12 months ]
  6. Mortality [ Time Frame: Change from Baseline at 3, 6 and 12 months ]


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Ages Eligible for Study:   40 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients classified between classes II to IV of New York Heart Association who have not participated in cardiac rehabilitation program in the three months before to recruitment.

Exclusion Criteria:

  • patients who have insufficient level of understanding to carry out the assessment procedures and / or intervention, as well as presenting musculoskeletal diseases, stroke or psychiatric diseases.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02468219


Locations
Brazil
Marlus Karsten
Porto Alegre, Rio Grande Do Sul, Brazil, 90050-170
Sponsors and Collaborators
Irmandade Santa Casa de Misericórdia de Porto Alegre
Federal University of Health Science of Porto Alegre
Investigators
Principal Investigator: Marlus Karsten, PhD Federal University of Health Science of Porto Alegre

Publications:

Responsible Party: Marlus Karsten, Professor, Federal University of Health Science of Porto Alegre
ClinicalTrials.gov Identifier: NCT02468219     History of Changes
Other Study ID Numbers: IR00002509/FWA
First Posted: June 10, 2015    Key Record Dates
Last Update Posted: March 7, 2018
Last Verified: March 2018

Keywords provided by Marlus Karsten, Federal University of Health Science of Porto Alegre:
aortic stenosis
aortic valve replacement
transcatheter aortic valve implantation
frailty
cardiac rehabilitation

Additional relevant MeSH terms:
Constriction, Pathologic
Aortic Valve Stenosis
Pathological Conditions, Anatomical
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction