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Palliative care to help people living long-term with a heart pump

Tests added palliative care in adults with advanced heart failure and an LVAD.

Plain-language title generated from the registry record
Registry title: Palliative Care Intervention to Improve Health Related Quality of Life for Patients on Long-Term LVAD Support

Key facts

Where
Fairfax and Washington D.C., United StatesSee the 2 sites

Where in United States

  • Inova Schar Heart and Vascular InstituteFairfax, United StatesNo longer taking part
  • MedStar Washington Hospital CenterWashington D.C., United StatesNo longer taking part

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Trial details

Who runs it
Medstar Health Research Institute
Trial code
NCT07445932
Record updated
3 March 2026
Original description
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.Read full original descriptionShow less

The PALL-VAD Study: Palliative Care Intervention to Improve Health Related Quality of Life for Patients With Heart Failure on Long-Term LVAD Support: A Pilot, Prospective, Randomized Trial

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.

Inclusion: LVAD patients >= 18 years of age; >= 1 year post-LVAD implantation.

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

ClinicalTrials.gov NCT07445932