Allocation Method for Advanced Heart Failure

(SOCIAL HF Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Disqualifiers: Inactive centers, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on improving the allocation of advanced heart failure treatments, such as heart transplants and ventricular assist devices. The researchers aim to ensure fair distribution by using a strategy called SOCIAL HF, which reduces bias and relies on objective criteria. The study will test this strategy in real-world settings to evaluate its effectiveness and potentially influence nationwide treatment allocation. The trial seeks professionals involved in advanced heart failure care, such as doctors and nurses, at centers that regularly assess a diverse group of patients. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could transform heart failure treatment allocation.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that this allocation method is safe for advanced heart failure therapies?

Research has shown that social factors, such as access to healthcare and community support, can affect heart failure outcomes. SOCIAL HF aims to improve heart failure treatment by reducing bias and using clear, fair methods.

Because SOCIAL HF emphasizes training and changes in group interactions rather than new drugs or devices, it poses no direct safety risks like those associated with medications. The goal is to enhance decision-making processes, assuring potential participants that this approach is safe and seeks to make care fairer and more effective. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the SOCIAL HF approach for advanced heart failure because it focuses on enhancing social support, which is often overlooked in traditional treatments. Unlike standard treatments that primarily involve medications or devices to manage heart function, SOCIAL HF aims to reduce bias and improve patient outcomes by fostering better group dynamics and employing objective measures of social support. This innovative method could lead to more holistic care for heart failure patients, potentially improving their quality of life and emotional well-being alongside their physical health.

What evidence suggests that this trial's strategy could be effective for advanced heart failure?

Research shows that advanced heart failure is a serious condition often leading to poor outcomes. Studies indicate that about half of the patients with advanced heart failure die within one year. In this trial, the treatment arm involves SOCIAL HF, which aims to improve the delivery of therapies like heart transplants and heart pumps. It employs methods to reduce bias and ensure fair and objective decision-making. This approach could lead to better and more effective treatment choices, potentially improving outcomes for patients with advanced heart failure. ^{4 5 6 7 8}

Who Is on the Research Team?

Khadijah Breathett, MD, MS

Principal Investigator

Indiana University

Are You a Good Fit for This Trial?

This trial is for heart transplant and ventricular assist device centers that see at least 50 minority patients and 50 women over two years. It includes professionals like coordinators, physicians, pharmacists, nurses, social workers involved in advanced therapy decisions. Centers not fully able to participate or no longer active are excluded.

Inclusion Criteria

Participants for the interview portion will be a subset of otherwise eligible advanced therapy professionals who are included on selection meeting attendance sheets at an included center

My center sees many patients from diverse backgrounds and women for advanced heart failure treatments.

You are currently on the waiting list for a heart transplant or have a ventricular assist device.

Exclusion Criteria

My treatment center is not equipped for the study's required training and evaluations.

If the center ceases to be an active heart failure/transplant center

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Training and Implementation

SOCIAL HF strategy is implemented, including bias reduction training and objective evaluations of social support

2 months

Multiple training sessions

Evaluation and Monitoring

Evaluation of SOCIAL HF implementation and monitoring of group function scores and clinician behavior changes

Up to 2 years

Regular monitoring and evaluation sessions

Follow-up

Participants are monitored for long-term outcomes and effectiveness of SOCIAL HF strategy

6 months after reaching study target

What Are the Treatments Tested in This Trial?

Interventions

• SOCIAL HF

Trial Overview The SOCIAL HF trial tests a strategy aimed at equitable allocation of heart failure therapies by reducing bias and using objective criteria over subjective judgment. The study's design may influence national guidelines on how advanced therapies for chronic diseases are allocated.

How Is the Trial Designed?

Group I: Sites Randomized to SOCIAL HF Experimental Treatment 1 Intervention

SOCIAL HF is composed of evidence-based disparities reduction training, employment of objective measures of social support, and changes to facilitate group dynamics.

Group II: Control Sites Active Control 1 Intervention

No Intervention

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

Despite advancements in heart failure (HF) treatments over the past 15-20 years, many patients are still not receiving optimal doses of medications, which can hinder their recovery and overall health outcomes.

The proposed practical approach algorithm aims to help physicians better implement guideline-directed therapies for HF patients, ensuring both safety and efficacy in treatment, as current guidelines lack detailed recommendations for inpatient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A practical approach to the guideline-directed pharmacological treatment of heart failure with reduced ejection fraction. Abdin, A., Bauersachs, J., Soltani, S., et al.[2023]

A multicenter study involving 1816 heart failure patients showed that a community-based multidisciplinary disease management program (DMP) significantly reduced 1-year all-cause mortality, with a hazard ratio of 0.65, indicating a 35% lower risk of death compared to standard care.

The DMP included structured patient education, home monitoring by trained nurses, and alerts for significant clinical changes, demonstrating that coordinated care can improve survival outcomes for heart failure patients after hospital discharge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a multidisciplinary heart failure disease management programme on 1-year mortality: Prospective cohort study. Laborde-Castérot, H., Agrinier, N., Zannad, F., et al.[2022]

Citations

1. onlinejcf.com onlinejcf.com/article/S1071-9164(25)00326-4/fulltext

HF STATS 2025: Heart Failure Epidemiology and ... Heart failure (HF) was a contributing cause in 425,147 deaths, accounting for 45% of cardiovascular deaths in the U.S. in 2022.

2. jacc.org jacc.org/doi/10.1016/j.jchf.2021.05.009

Advanced Heart Failure Epidemiology and Outcomes The goal of this study was to evaluate the prevalence, characteristics, and outcomes of patients with advanced heart failure (HF) in a ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8487916/

Advanced Heart Failure Epidemiology and Outcomes Half of patients with advanced heart failure die within one year. Translational Outlook 1: Once patients develop advanced heart failure, outcomes are poor.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05390411

Seeking Objectivity in Allocation of Advanced Heart Failure ... Study target is defined as time 50 patients of color and 50 women have been evaluated for advanced heart failure therapies per center. Baseline, 2 months, and ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10338256/

Advanced heart failure: a contemporary approach - PMC Advanced heart failure (HF) is defined as the persistence of severe symptoms despite the use of optimized medical, surgical, and device therapies.

6. nature.com nature.com/articles/s41598-025-10735-2

Joint association of social determinants of health and ... Congestive heart failure (CHF) and social determinants of health (SDoH) are each associated with increased mortality risk, ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10289795/

The Impact of Health Care Disparities on Patients With Heart ... Elements contributing to inequities in heart failure (HF) care and outcomes among racial and ethnic minority groups. The higher risk for HF, and inequities in ...

8. ahajournals.org ahajournals.org/doi/10.1161/JAHA.122.026590

Influence of Social Determinants of Health on Heart Failure ... Prior research suggests an association between clinical outcomes in heart failure (HF) and social determinants of health (SDoH).