Heart Failure Clinical Trial
— VAFRACTOfficial title:
The Effects of Echo-optimization of Left Ventricular Assist Devices on Functional Capacity, a RAndomized Controlled Trial (VAFRACT)
Verified date | October 2021 |
Source | Universita di Verona |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
After the implantation of a left ventricular assist device (LVAD), many patients continue to experience exercise intolerance. LVAD echo guided optimization (EO) determines a more favorable hemodynamic profile and could provide an improvement on functional capacity (FC). VAFRACT is a prospective randomized trial to evaluate the additional benefit of an EO approach on FC, measured by cardiopulmonary exercise test (CPET), in LVAD optimization free population.
Status | Completed |
Enrollment | 27 |
Est. completion date | August 31, 2020 |
Est. primary completion date | December 30, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - at least 3 months after LVAD implantation; - compliance to the required follow-up schedule; - age 18 or above or of legal age to give informed consent specific to state and national laws. Exclusion Criteria: - distance of less than 150 meters on the six-minute walk test (6MWT) or impossibility to perform CPET - recent finding of any major device-related complication (sepsis, thrombosis …). |
Country | Name | City | State |
---|---|---|---|
Italy | Department of Cardiac Surgery, University of Verona | Verona |
Lead Sponsor | Collaborator |
---|---|
Universita di Verona |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | VO2 Peak | peak oxygen uptake measured by cardiopulmonary exercise test | three months | |
Secondary | Number of Participants With LVAD-related Hospitalizations | Rate of hospitalizations for: device thrombosis, hemorrhagic events, infections, right heart failure, arrhythmias. | Three months | |
Secondary | QoL: The EQ-5D Questionnaire | Changes in quality of life perceived by EuroQoL (quality of life) Scale. It is an instrument which evaluates the quality of life measuring with one question: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The answers given to these question (1 = no problems; 2 = some problems; 3 = extreme problems) are converted into EQ-5D index, an utility scores anchored at 0 for death and 1 for perfect health. The EQ-5D questionnaire also includes a Visual Analog Scale (VAS), by which respondents can report their perceived health status with a grade ranging from 0 (the worst possible health status) to 100 (the best possible health status). | Three months | |
Secondary | Nt-proBNP | Nt-proBNP levels | Three months | |
Secondary | Right Ventricular Function | Fractional area change of right ventricle assessed by echocardiography | Three months | |
Secondary | CPET Exercise Time | Cardiopulmonary exercise time | Three months |
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