Clinical trial NCT03937570: Effects of Echo-optimization of Left Ventricular Assist Devices on Functional Capacity (VAFRACT)
Official title: The Effects of Echo-optimization of Left Ventricular Assist Devices on Functional Capacity, a RAndomized Controlled Trial (VAFRACT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: left ventricular assist device
echo-optimization
functional capacity
cardiopulmonary exercise test
Lead sponsor: Universita di Verona
Sponsor class: OTHER
First posted: 2019-05-03
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: The use of Left Ventricular Assist Devices (LVAD) is a viable therapeutic option to improve survival and quality of life of patients with advanced and refractory heart failure (HF). However, after the implantation of an LVAD, patients' functional capacity (FC) is still reduced with maximum oxygen uptake (VO2 peak) values calculated at the cardiopulmonary exercise test (CPET) ranging from 11 to 20 ml/kg/min. LVAD echo guided optimization (EO) determines a more favorable hemodynamic profile, in particular for the right ventricle, and could provide an improvement on FC. VAFRACT is a prospective randomized trial to evaluate the additional benefit of an EO approach on FC, measured by CPET in LVAD optimization free population.

The optimal device speed is defined as the one that allows an intermittent aortic valve opening and a neutral position of the interventricular septum without increasing aortic or tricuspid regurgitation associated or not to a dilatation of the right ventricle (RV). In this condition it is reasonable to expect a more favorable hemodynamic profile for the RV and a better response in terms of functional capacity.

Subjects studied are HF patients supported with a continuous-flow LVAD: HeartMate II (Thoratec Inc., Pleasanton, CA) and HeartMate 3 (HM 3, Abbott, North Chicago, IL). Patients are recruited from our Day Hospital of the Cardiac Surgery Department at the University Hospital of Verona.

Eligibility criteria: 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 ...).

Primary outcomes:
measure: VO2 Peak
timeFrame: three months
Secondary outcomes:
measure: Number of Participants With LVAD-related Hospitalizations
timeFrame: Three months
measure: QoL: The EQ-5D Questionnaire
timeFrame: Three months
measure: Nt-proBNP
timeFrame: Three months
measure: Right Ventricular Function
timeFrame: Three months
measure: CPET Exercise Time
timeFrame: Three months
Other outcomes:
Locations:
city: Verona
country: Italy
facility: Department of Cardiac Surgery, University of Verona
Study officials:
name: MARZIA LILLIU, MD
role: PRINCIPAL_INVESTIGATOR
References: