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Effects of Echo-optimization of Left Ventricular Assist Devices on Functional Capacity (VAFRACT) (VAFRACT)
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Heart Failure | Device: echo-optimization | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 36 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | The Effects of Echo-optimization of Left Ventricular Assist Devices on Functional Capacity, a RAndomized Controlled Trial (VAFRACT) |
| Actual Study Start Date : | February 8, 2018 |
| Estimated Primary Completion Date : | June 30, 2019 |
| Estimated Study Completion Date : | December 31, 2019 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: EO GROUP
Patients underwent LVAD echo-optimization; the optimal device speed is confirmed at the end of procedure.
|
Device: echo-optimization
LVAD echo-optimization consists of routine comprehensive transthoracic echocardiography at the baseline speed setting, followed by stepwise incremental adjustments to the LVAD speed (revolutions per minute: rpm), with collection of prespecified echocardiographic parameters at each new speed (eg, left ventricle end-diastolic diameter, interventricular septal position, aortic valve opening frequency/duration, tricuspid and/or mitral regurgitation severity). The optimal velocity 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. The recommended speed range varies according to the indications given in the data sheet for each specific device.
|
|
No Intervention: CONTROL GROUP
Patients underwent LVAD echo-optimization, but the optimal device speed is not confirmed at the end of procedure.
|
- VO2 peak [ Time Frame: three months ]peak oxygen uptake measured by cardiopulmonary exercise test
- LVAD-related hospitalizations [ Time Frame: Three months ]Rate of hospitalizations for: device thrombosis, hemorrhagic events, infections, right heart failure, arrhythmias.
- QoL: The EQ-5D questionnaire [ Time Frame: Three months ]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).
- Nt-proBNP [ Time Frame: Three months ]Nt-proBNP levels
- Right ventricular function [ Time Frame: Three months ]Fractional area change of right ventricle assessed by echocardiography
- CPET exercise time [ Time Frame: Three months ]Cardiopulmonary exercise time
| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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 …).
| Contact: MARZIA LILLIU, MD | +393281383539 | marzialilliu@gmail.com |
| Italy | |
| Department of Cardiac Surgery, University of Verona | Recruiting |
| Verona, Italy, 37126 | |
| Contact: MARZIA LILLIU, MD +393281383539 marzialilliu@gmail.com | |
| Principal Investigator: | MARZIA LILLIU, MD |
| Tracking Information | |||||||
|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | May 1, 2019 | ||||||
| First Posted Date ICMJE | May 3, 2019 | ||||||
| Last Update Posted Date | May 7, 2019 | ||||||
| Actual Study Start Date ICMJE | February 8, 2018 | ||||||
| Estimated Primary Completion Date | June 30, 2019 (Final data collection date for primary outcome measure) | ||||||
| Current Primary Outcome Measures ICMJE |
VO2 peak [ Time Frame: three months ] peak oxygen uptake measured by cardiopulmonary exercise test
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||
| Change History | |||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||
| Descriptive Information | |||||||
| Brief Title ICMJE | Effects of Echo-optimization of Left Ventricular Assist Devices on Functional Capacity (VAFRACT) | ||||||
| Official Title ICMJE | The Effects of Echo-optimization of Left Ventricular Assist Devices on Functional Capacity, a RAndomized Controlled Trial (VAFRACT) | ||||||
| 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. |
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| Study Type ICMJE | Interventional | ||||||
| Study Phase ICMJE | Not Applicable | ||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Heart Failure | ||||||
| Intervention ICMJE | Device: echo-optimization
LVAD echo-optimization consists of routine comprehensive transthoracic echocardiography at the baseline speed setting, followed by stepwise incremental adjustments to the LVAD speed (revolutions per minute: rpm), with collection of prespecified echocardiographic parameters at each new speed (eg, left ventricle end-diastolic diameter, interventricular septal position, aortic valve opening frequency/duration, tricuspid and/or mitral regurgitation severity). The optimal velocity 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. The recommended speed range varies according to the indications given in the data sheet for each specific device.
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||
| Recruitment Status ICMJE | Unknown status | ||||||
| Estimated Enrollment ICMJE |
36 | ||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||
| Estimated Study Completion Date ICMJE | December 31, 2019 | ||||||
| Estimated Primary Completion Date | June 30, 2019 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 80 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 | Italy | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT03937570 | ||||||
| Other Study ID Numbers ICMJE | 1397CESC | ||||||
| Has Data Monitoring Committee | Yes | ||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Marzia Lilliu, Universita di Verona | ||||||
| Study Sponsor ICMJE | Universita di Verona | ||||||
| Collaborators ICMJE | Not Provided | ||||||
| Investigators ICMJE |
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| PRS Account | Universita di Verona | ||||||
| Verification Date | May 2019 | ||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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