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NCT07445932Not yet recruiting

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

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

Source: ClinicalTrials.gov · Last updated 3 Mar 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
90 (estimated)
First submitted
11 Feb 2026
Start date
Mar 2026
Primary completion date
Mar 2027
Lead sponsor
Medstar Health Research Institute
NCT number
NCT07445932

What you commit to

  • Study type: Interventional
  • Planned participants: 90
  • From Mar 2026 to the primary completion date, Mar 2027
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Receiving outpatient palliative care in the last 6 months
  • Renal replacement therapy

Other illness

  • 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.

Other

  • 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.

Who the study is looking for

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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Inova Schar Heart and Vascular Institute
Coordinator of this site? Confirm its status
FairfaxUnited StatesUnknown status
MedStar Washington Hospital Center
Coordinator of this site? Confirm its status
Washington D.C.United StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.