NCT07805811Not yet recruitingPhase 2
Testing Heart Failure Resilience Intervention for Caregivers (HEROIC) in Advanced Heart Failure
Source: ClinicalTrials.gov · Last updated 4 Sept 2026
Brief summary (registry, in English)
This study will test the mechanisms of a multi-component, nurse-led, primary palliative care intervention, HEart failure Resilience Intervention for Caregivers (HEROIC) to improve caregiver mental well-being, patient health-related quality of life and unplanned acute care in the setting of advanced heart failure. The investigators will conduct a multi-site, randomized controlled trial to test proposed mechanisms of action in a large sample (N=500) of persons with heart failure and the caregivers. The investigators will also examine variation in response to HEROIC components by heart failure subgroup (ventricular assist device, heart transplant or medically managed heart failure).
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 500 (estimated)
- First submitted
- 1 Sept 2026
- Start date
- 4 Jan 2027
- Primary completion date
- 30 Nov 2030
- Lead sponsor
- Johns Hopkins University
- Diseases
- Heart failure
- NCT number
- NCT07805811
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 500
- From 4 Jan 2027 to the primary completion date, 30 Nov 2030
- 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.
Other illness
- Patients and caregivers who screen positive for severe cognitive impairment Telephone Interview for Cognitive Screening (TICS-M) will be excluded.
Criteria the registry did not label
- Caregiver Inclusion Criteria:
- English or Spanish-speaking.
- \> 18 years old.
- Supports at least one activity of daily living (ADL) or instrumental activity of daily living IADL) for the person with HF (care recipient).
- Lives with the person with HF or visits regularly (e.g. weekly phone calls and visits at least once per month) to provide ADL/IADL support.
- ≥5 on the Zarit Burden Interview
- Patient Inclusion Criteria:
- English or Spanish-speaking.
- \> 18 years old.
- Reports needing help with at least one activity of daily living or instrumental activity of daily living.
- Identifies a primary caregiver AND caregiver consents.
- Diagnosed with heart failure. AND
- If Medically managed, no Ventricular Assist Device (VAD) or Transplant (TX): Documentation of HF with preserved ejection fraction OR HF with reduced ejection fraction (LVEF\<40%) OR Documented American College of Cardiology / American Heart Association (ACC/AHA) HF stage C or D (EMR) OR Documentation of New York Heart Association functional class II - IV (EMR)
- If ventricular assist device: \> 1 month since implant AND ambulatory/outpatient
- If heart transplant: \> 1 month since Heart Transplant (HTx) AND ambulatory/outpatient
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 |
|---|---|---|---|
| Johns Hopkins University School of Nursing Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| University of Colorado Anschutz Coordinator of this site? Confirm its status | Denver | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.