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

Starting soon · Not applicable

Conditions studied: Advanced Heart Failure, Mechanical Circulatory Support, Left Ventricular Assist Device, Palliative Care

In brief

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 facts

Study ID

NCT07445932

Run by

Medstar Health Research Institute

People needed

90

Starts

2026-03-01

Expected to finish

2027-03-01

Last updated by the study team

2026-03-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• LVAD patients >= 18 years of age
• >= 1 year post-LVAD implantation

You may not qualify if…

• Listed for heart transplantation. Undergoing evaluation for heart transplantation, however, is not an exclusion.
• Non-English speaking
• Receiving outpatient palliative care in the last 6 months
• Renal replacement therapy
• Non-cardiac terminal illness
• Women who are pregnant or planning to become pregnant
• Inability to comply with study protocol and follow up
• Inabilty to provide consent.
• Cognitive impairment or intellectual disability that prohibits successful completion of the HRQoL scales or compliance with the study protocol and follow up.

Where it is running

• MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States
• Inova Schar Heart and Vascular Institute — Fairfax, Virginia, United States

Full record on ClinicalTrials.gov

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