Clinical Trial: Assessment and Cardiovascular Rehabilitation in Patients With Severe Aortic Stenosis
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Multiparametric Assessment and Cardiovascular Rehabilitation in Patients With Severe Aortic Stenosis Undergoing Valve Surgery: Effects on Hemodynamics, Functional Capacity
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.
Detailed Summary:
Sponsor: Irmandade Santa Casa de Misericórdia de Porto Alegre
Current Primary Outcome: Functional Capacity by the Six-Minute Walk Test [ Time Frame: Change from Baseline at 3, 6 and 12 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Endothelium Function by the Reactive Hyperemia Index [ Time Frame: Change from Baseline at 3, 6 and 12 months ]
- Autonomic Modulation by the Heart Rate Variability [ Time Frame: Change from Baseline at 3, 6 and 12 months ]
- Cardiac Output by the Impedance Cardiography [ Time Frame: Change from Baseline at 3, 6 and 12 months ]
- Frailty by Cardiovascular Health Study Index [ Time Frame: Change from Baseline at 3, 6 and 12 months ]
- Quality of Life by the Minnesota Living with Heart Failure Questionnaire [ Time Frame: Change from Baseline at 3, 6 and 12 months ]
- Mortality [ Time Frame: Change from Baseline at 3, 6 and 12 months ]
Original Secondary Outcome: Same as current
Information By: Irmandade Santa Casa de Misericórdia de Porto Alegre
Dates:
Date Received: May 21, 2015
Date Started: March 2015
Date Completion:
Last Updated: June 5, 2015
Last Verified: June 2015
