Multidisciplinary team clinic and assessments (Cardiopulmonary exercise test, six-minute-walk-test, MoCA, Quality of Life questionnaires) for Heart Failure

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Massachusetts General Hospital, Boston, MA
Heart Failure
Multidisciplinary team clinic and assessments (Cardiopulmonary exercise test, six-minute-walk-test, MoCA, Quality of Life questionnaires) - Other
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

Current standard of care for ventricular-assist device (VAD) patients is composed of a multidisciplinary team (MDT), which is required in pre-implant and implant hospitalization care but is lacking in post-implant care. Post-implant care is currently centered around the avoidance of complications of VAD support, including cerebrovascular insult (CVA/TIA), gastrointestinal bleeding and infection. Despite major improvements in survival for VAD patients, quality of life and physical functioning measures have not seen significant improvements. This study will include two prospective interventional cohorts and a retrospective control cohort. The first prospective interventional cohort will consist of patients who recently underwent LVAD implantation at Massachusetts General Hospital, and their caregivers. These patients will receive only multidisciplinary team care from the time of their implant. The second prospective interventional cohort will consist of patients who have previously undergone LVAD implantation at Massachusetts General Hospital who are being followed-up with standard-of-care VAD clinic visits, and their caregivers. These patients will receive a hybrid of multidisciplinary team care and standard-of-care visits. The historical control cohort will consist of retrospective data collection on patients who have undergone LVAD implantation in the past and no longer have an LVAD implanted (due to transplant, death, explant, etc.), and will be matched with the prospective interventional patients. The purpose of this study is to characterize the impact of routine MDT care on health-related quality of life, caregiver burnout and functional capacity of outpatient VAD patients, and to determine if implementation of MDT care is associated with a reduction in complications and readmissions in VAD patients at one- and two-years post implant. The investigators hypothesize that the MDT clinic model in addition to standard of care VAD management will positively impact the quality of life and functional status of VAD patients. Subjects who consent to this study will be seen by the MDT providers and complete Cardiopulmonary Exercise Tests (CPET), six-minute-walk-tests, and quality of life questionnaires. The primary caregivers of these subjects will complete a Caregiver Self-Assessment at two timepoints. We anticipate to enroll 20 newly-implanted VAD patients in the pure-MDT arm, 35 pre-existing VAD patients in hybrid-MDT/SOC arm, and 55 primary caregivers.

Treatment Effectiveness

Study Objectives

8 Primary · 3 Secondary · Reporting Duration: Change from pre-implant VE/VCO2 at 12 months post LVAD implantation

Month 12
Respiratory Exchange Ratio (RER) in % during Cardiopulmonary Exercise Test
Month 12
Minute ventilation per carbon dioxide production (VE/VCO2) during Cardiopulmonary Exercise Test
Month 12
Blood pressure in mmHg during Cardiopulmonary Exercise Test
Month 12
Heart rate in beats per minute during Cardiopulmonary Exercise Test
Month 12
Peak VO2 in mL/kg of body weight/min during Cardiopulmonary Exercise Test
Month 12
EuroQoL (EQ-5D and EuroVAS) to measure quality of life
Kansas City Cardiomyopathy Questionnaire (KCCQ) to measure quality of life
Montreal Cognitive Assessment (MoCA) to measure cognitive function
Month 24
Number of VAD related complications
Number of readmissions
Time to readmission in days

Trial Safety

Trial Design

4 Treatment Groups

Retrospective control cohort
1 of 4
Prospective interventional cohort of newly-implanted patients
1 of 4
Prospective interventional cohort of previously-implanted patients
1 of 4
Primary caregiver cohort
1 of 4
Active Control
Experimental Treatment

110 Total Participants · 4 Treatment Groups

Primary Treatment: Multidisciplinary team clinic and assessments (Cardiopulmonary exercise test, six-minute-walk-test, MoCA, Quality of Life questionnaires) · No Placebo Group · N/A

Prospective interventional cohort of newly-implanted patients
Other
Experimental Group · 1 Intervention: Multidisciplinary team clinic and assessments (Cardiopulmonary exercise test, six-minute-walk-test, MoCA, Quality of Life questionnaires) · Intervention Types: Other
Prospective interventional cohort of previously-implanted patients
Other
Experimental Group · 1 Intervention: Multidisciplinary team clinic and assessments (Cardiopulmonary exercise test, six-minute-walk-test, MoCA, Quality of Life questionnaires) · Intervention Types: Other
Primary caregiver cohort
Behavioral
Experimental Group · 1 Intervention: Caregiver Self-Assessment · Intervention Types: Behavioral
Retrospective control cohortNoIntervention Group · 1 Intervention: Retrospective control cohort · Intervention Types:

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: change from pre-implant ve/vco2 at 12 months post lvad implantation
Closest Location: Massachusetts General Hospital · Boston, MA
Photo of Massachusetts General Hospital 1Photo of Massachusetts General Hospital 2Photo of Massachusetts General Hospital 3
1993First Recorded Clinical Trial
94 TrialsResearching Heart Failure
2427 CompletedClinical Trials

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,660 Previous Clinical Trials
30,828,687 Total Patients Enrolled
44 Trials studying Heart Failure
211,269 Patients Enrolled for Heart Failure
Erin Coglianese, MDPrincipal InvestigatorMassachusetts General Hospital

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Individuals who have not previously attended standard-of-care VAD follow-up clinic visits.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.