Status:
RECRUITING
iCardia4HF: Multi-component mHealth Intervention for Patients With Heart Failure
Lead Sponsor:
University of Illinois at Chicago
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
The goal of this factorial randomized trial is to examine the independent and synergistic efficacies of two mobile health technology interventions in people with chronic heart failure. The first inter...
Detailed Description
Heart failure (HF) remains one of the most frequent principal diagnoses for hospitalization and a leading cause of death in the United States. Up to 65% of HF readmissions are the result of insufficie...
Eligibility Criteria
Inclusion
- Diagnosis of Stage C Heart Failure
- ≥ 18 years of age
- Transthoracic Echocardiogram or Cardiac MRI performed in the last 3 years and LVEF results available
- Patient is actively treated with oral loop diuretics for chronic heart failure
- Hospitalization due to acute decompensated heart failure within 24 months before randomization and/or insufficient self-care per SCHFI assessment (score of ≤3, in at least two items of the SCHFI v7.2 maintenance, symptom monitoring, or self-care management subscale)
- Ability to speak and read English
Exclusion
- Implanted ventricular assist device
- High urgent listed for heart transplantation
- Acute coronary syndrome within the last 7 days before randomization
- Revascularization and/or CRT implantation within 28 days before randomization
- Planned revascularization, transcatheter aortic valve implantation, MitraClip and/or CRT implantation within 3 months after randomization
- End-stage HF (hospice candidate)
- Discharge to a setting other than home
- Individuals who have a home nurse or are not able to take care of self (eat, dress, walk, bathe, take medications, or use the toilet)
- Chronic renal insufficiency with hemodialysis or estimated Glomerular Filtration Rate \<25 mL
- Active cancer, currently undergoing treatment (e.g. radiation immunotherapy)
- Existence of any disease reducing life expectancy to less than 1 year
- Cognitive impairment (e.g., Dementia, Parkinson disease, Alzheimer disease, MoCA\<18, impaired self-determination, lacking ability to communicate)
- Major physical impairment (e.g., inability to walk, bound on a wheelchair)
- Unwillingness to use study equipment
- Active substance abuse
- Currently pregnant, less than 3-month post-partum or pregnancy anticipated during the study
- Participation in other treatment studies or remote patient management programs
- Participation in the iCardia4H pilot trial (conducted before this study)
Key Trial Info
Start Date :
October 4 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2028
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT06205225
Start Date
October 4 2024
End Date
September 30 2028
Last Update
March 27 2025
Active Locations (2)
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1
Rush University Medical Center
Chicago, Illinois, United States, 60612
2
University of Illinois Hospital & Health Sciences System
Chicago, Illinois, United States, 60612