Palliative Care Intervention to Improve Health Related Quality of Life for Patients on Long-Term LVAD Support

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Medstar Health Research Institute
Study ID
NCT07445932
Status
Not Yet Recruiting

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Conditions

  • Advanced Heart Failure
  • Left Ventricular Assist Device
  • Mechanical Circulatory Support
  • Palliative Care

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Palliative care intervention — BEHAVIORAL
    The palliative care arm mirrors the intervention described in a cohort of patients with HF in the PAL-HF trial. The intervention will be conducted by a palliative care specialist nurse clinician with standardized training in administering the intervention. The palliative care clinician will conduct visits within 2 weeks of randomization/enrollment and subsequently approximately every 4-6 weeks with the patient for 6 months total duration. The patient will be referred for interdisciplinary supportive care from the palliative care chaplain, social worker, and/or pharmacist based on NP evaluation. Additionally, based on baseline clinical assessment scales and symptoms, patients will be offered supportive medications or referrals for cardiac rehabilitation and behavioral health/psychiatry.

Study Details

Background: While left ventricular assist device (LVAD) therapy improves survival in patients with advanced heart failure (AHF), unique LVAD-related burdens may impact health-related quality of life (HRQoL). Palliative care specialists are key members of the multidisciplinary care team for patients with long-term-LVAD (LT-LVAD), offering specialized, comprehensive, holistic care. Problem: A seminal study of palliative care in patients with heart failure (PAL-HF trial) demonstrated that outpatient palliative care improved HRQoL, depression, anxiety, and spiritual well-being compared to usual care. The impact of longitudinal palliative care on HRQoL in LT-LVAD patients is unknown. Objective: The investigators aim to conduct the first study examining a palliative care intervention to improve HRQoL among LT- LVAD recipients (patients who have lived with LT-LVAD for at least six months and are not heart transplant candidates) at two centers (MedStar Health and Inova) in the Mid-Atlantic Region. Given the demographics of the study institutions, the investigators anticipate a socioeconomically and racially diverse cohort of patients with subgroups who may disproportionately experience LVAD-related burdens relative to benefits. Aims: The first aim is to assess baseline measures of HRQoL in LT-LVAD patients to understand differences in HRQoL across subgroups and multiple, understudied domains. The second aim is to test the feasibility and acceptability of a randomized, unblinded pilot study of a palliative care interdisciplinary intervention in this population. Significance: Results of this study will inform the development of a large randomized controlled trial to test the effectiveness of palliative care intervention in improving HRQoL in LT-LVAD patients. If results are positive, this will revolutionize the post-LVAD treatment paradigm, by making palliative care integration the standard of care for longitudinal LT-LVAD patient management.

Key Dates

Start date
Mar 1, 2026
Status verified
Feb 2026
Primary completion
Mar 1, 2027
Completion
Mar 1, 2027

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • No Intervention: Usual care
    The usual care arm will consist of routine LVAD care with clinician-triggered referral for palliative care specialist evaluation.
  • Active Comparator: Palliative care intervention
    The palliative care arm mirrors the intervention described in a cohort of patients with HF in the PAL-HF trial. The intervention will be conducted by a palliative care specialist nurse clinician with standardized training in administering the intervention. The palliative care clinician will conduct visits within 2 weeks of randomization/enrollment and subsequently approximately every 4-6 weeks with the patient for 6 months total duration. The patient will be referred for interdisciplinary supportive care from the palliative care chaplain, social worker, and/or pharmacist based on NP evaluation. Additionally, based on baseline clinical assessment scales and symptoms, patients will be offered supportive medications or referrals for cardiac rehabilitation and behavioral health/psychiatry.

Primary Outcome Measure

Trial enrollment [ Time Frame: From enrollment to end of intervention at 6 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
MedStar Washington Hospital CenterWashington D.C.District of Columbia20010
Richa Gupta, MD MPH
[email protected]
202-877-4698
Richa Gupta, MD MPH (PRINCIPAL_INVESTIGATOR)
Inova Schar Heart and Vascular InstituteFairfaxVirginia22042
Anirudh Rao, MD
[email protected]
703-776-4289
Anirudh Rao, MD (PRINCIPAL_INVESTIGATOR)

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By research site
MedStar Washington Hospital Center· Washington D.C., DCInova Schar Heart and Vascular Institute· Fairfax, VA

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