Palliative Care for Congestive Heart Failure

(PALL-VAD Trial)

Not yet recruiting at 1 trial location
RG
Overseen ByRicha Gupta, MD MPH
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Medstar Health Research Institute
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

Why 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?

RG

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

1 year post-LVAD implantation
I am 18 or older and have an LVAD device.

Exclusion Criteria

Women who are pregnant or planning to become pregnant
I have received outpatient palliative care in the past 6 months.
Cognitive impairment or intellectual disability that prohibits successful completion of the HRQoL scales or compliance with the study protocol and follow up.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Establish baseline measures of HRQoL across multiple domains in LT-LVAD patients

5 weeks
1 visit (in-person)

Intervention

Randomized, unblinded pilot study of a palliative care interdisciplinary intervention

6 months
Visits every 4-6 weeks (in-person)

Follow-up

Participants are monitored for safety and effectiveness after intervention

4 weeks

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

Group I: Usual careActive Control1 Intervention
Group II: Palliative care interventionActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Medstar Health Research Institute

Lead Sponsor

Trials
202
Recruited
187,000+

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.

Palliative 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 ...

Integrating 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 ...

(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 ...