Palliative Care for Congestive Heart Failure
(PALL-VAD Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how palliative care, a supportive care approach, can improve the quality of life for individuals living with a long-term left ventricular assist device (LVAD) due to advanced heart failure. Participants will either continue with their usual LVAD care or receive additional support from a palliative care team, which includes regular visits and access to supportive services like social work or pharmacy. The trial aims to determine if this extra care can alleviate some of the burdens associated with living with an LVAD. It is suitable for those who have had an LVAD for at least a year and are not candidates for a heart transplant. As an unphased trial, this study provides a unique opportunity to explore additional supportive care options that could enhance quality of life.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that this palliative care intervention is safe for LT-LVAD patients?
Research has shown that palliative care is generally safe for people with heart failure. Studies indicate that this type of care can improve quality of life and emotional well-being without causing major side effects. For example, the PAL-HF trial found that patients who received palliative care experienced better outcomes in terms of depression and anxiety compared to those who received regular care. This suggests that palliative care is well-tolerated and beneficial for heart failure patients.
The treatment involves a team of specialists, including nurses and social workers, who provide support tailored to each person's needs. This approach is widely recommended as part of the standard care for heart failure. Overall, evidence supports the safety and positive impact of palliative care in managing heart failure symptoms.12345Why are researchers excited about this trial?
Researchers are excited about the palliative care intervention for congestive heart failure because it offers a holistic approach that goes beyond the usual care. Unlike standard treatments that primarily focus on managing heart failure symptoms with medications like ACE inhibitors or beta-blockers, this intervention includes regular visits from a specially trained palliative care nurse. These visits occur every 4-6 weeks over six months and involve comprehensive support from a team that could include chaplains, social workers, and pharmacists. This integrated approach aims to improve quality of life by addressing emotional, social, and spiritual needs alongside medical care. Such a multi-disciplinary method could transform how we manage not just symptoms but the overall well-being of heart failure patients.
What evidence suggests that this palliative care intervention might be an effective treatment for congestive heart failure?
Research has shown that palliative care can greatly improve the quality of life for people with heart failure. For example, the PAL-HF trial found that patients who received palliative care in an outpatient setting experienced better overall well-being, with less depression and anxiety, compared to those who received standard care. In this trial, participants will join either a palliative care intervention arm or a usual care arm. The palliative care intervention mirrors the approach used in the PAL-HF trial, involving regular visits by a palliative care specialist nurse clinician. A review of several studies also found that palliative care improved health outcomes for people with advanced heart failure. These findings suggest that palliative care could benefit patients living with long-term heart support devices, like left ventricular assist devices (LVADs), and might be an important part of managing advanced heart failure.678910
Who Is on the Research Team?
Richa Gupta, MD
Principal Investigator
Medstar Health Research Institute
Are You a Good Fit for This Trial?
This trial is for adults (18+) who have had a left ventricular assist device (LVAD) for at least one year and are not candidates for heart transplant. People can't join if they are pregnant, already getting palliative care, have major cognitive issues, don't speak English, have another terminal illness, or can't follow the study protocol.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Establish baseline measures of HRQoL across multiple domains in LT-LVAD patients
Intervention
Randomized, unblinded pilot study of a palliative care interdisciplinary intervention
Follow-up
Participants are monitored for safety and effectiveness after intervention
What Are the Treatments Tested in This Trial?
Interventions
- Palliative Care Intervention
Trial Overview
The study is testing whether adding regular palliative care to standard treatment can improve quality of life in people living long-term with an LVAD. Participants will be randomly assigned to receive either this extra support or usual care.
How Is the Trial Designed?
2
Treatment groups
Active Control
The usual care arm will consist of routine LVAD care with clinician-triggered referral for palliative care specialist evaluation.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Medstar Health Research Institute
Lead Sponsor
Inova Schar Heart and Vascular
Collaborator
Citations
Palliative Care in Chronic Heart Failure: A Systematic Review ...
Chronic heart failure (CHF) is a global health problem affecting more than 64 million people worldwide [1,2]. It is characterized by a ...
Palliative Care Interventions for Patients with Heart Failure
Objective: To systematically characterize interventions and effectiveness of palliative care for advanced heart failure (HF) patients.
Integration of Palliative Care into Heart Failure Care
Palliative Care in Heart Failure: Evidence Base. A number of studies have examined the effectiveness of various PC interventions for patients with HF.
4.
journals.lww.com
journals.lww.com/jhpn/fulltext/2022/08000/palliative_care_for_patients_with_heart_failure_.12.aspxPalliative Care for Patients With Heart Failure
Abbreviations: CHF, congestive heart failure; CHFQ, Chronic Heart Failure Questionnaire; CNS, clinical nurse specialist; DNR, do-not-resuscitate; EF, ejection ...
Palliative Care Across the Spectrum of Heart Failure
Results of a hospital-based palliative care intervention for patients with an acute exacerbation of chronic heart failure. J Card Fail. 2016;22:12: 1033 ...
Integrating Palliative Care into the Management of Heart ...
Palliative care (PC) is recommended as a standard of practice for all patients with heart failure (HF) and is supported by evidence of improved ...
7.
aacnjournals.org
aacnjournals.org/ccnonline/article/41/3/e9/31462/Integrating-Palliative-Care-Into-Heart-FailureIntegrating Palliative Care Into Heart Failure Management
The Sertraline Against Depression and Heart Disease in Chronic Heart Failure (SADHART-CHF) study found that although sertraline did not have ...
Palliative Care in Chronic Heart Failure: A Systematic ...
Chronic heart failure (CHF) is a global health problem affecting more than 64 million people worldwide [1,2]. It is characterized by a progressive decline in ...
Palliative Care in the Treatment of Advanced Heart Failure
Roughly 5% of patients with heart failure have end-stage disease that is refractory to medical therapy (stage D heart failure). Palliative care ...
10.
researchgate.net
researchgate.net/publication/404122184_Palliative_care_interventions_and_outcomes_in_patients_with_heart_failure_an_umbrella_review(PDF) Palliative care interventions and outcomes in ...
Palliative care interventions and outcomes in patients with heart failure: an umbrella review ... data on a range of major clinical heart ...
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