BridgeMD
New treatment option for Heart Failure
Official title iCardia4HF: Multi-component mHealth Intervention for Patients With Heart Failure
ClinicalTrials.gov ID: NCT06205225
What this study is testing
- What it's testing
- 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 intervention involves the use of multiple consumer mHealth apps and sensor devices (MyApps) for heart failure self-care (maintenance, monitoring, and management).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
You likely can't join if
- 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)
See the full eligibility criteria
- 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...
- Ability to speak and read English
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
Compensation & support
A stipend or compensation may be offered.
Compensation likely.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.