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
- Diseases
- Heart failure
- 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
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Inova Schar Heart and Vascular Institute Coordinator of this site? Confirm its status | Fairfax | United States | Unknown status |
| MedStar Washington Hospital Center Coordinator of this site? Confirm its status | Washington D.C. | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.