Improving outcomes for heart failure and acute myocardial infarction patients through care coordination
Official title: Care cOordination Using Mobile Technology to Enhance Patient Empowerment in Acute Comorbidities to aSSess Improvement in Outcomes in Hospital readmissioNs
Run by Aventyn, Inc. · NCT04905160 · Data updated 2026-11-12
This study is testing a new digital tool to help patients with heart failure or heart attacks get better care and reduce their chances of going back to the hospital.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 1000 (estimated) |
| Sponsor | Aventyn, Inc. Industry-sponsored |
| Locations | 1 site (Phoenix, Arizona) |
| Status | Recruiting |
| Started | February 18, 2021 |
| Main results expected | February 22, 2025 |
| Study ends | December 22, 2026 |
| Registry record updated | March 20, 2024 |
| Trial ID | NCT04905160 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include men and women over 18 years old who are hospitalized with a primary diagnosis of ADHF or acute MI.
✕Probably not a fit
Patients who do not have a primary diagnosis of heart failure or acute MI, or those who are unable to provide informed consent, may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study focuses on patients hospitalized with acute decompensated heart failure (ADHF) or acute myocardial infarction (MI) to assess the effectiveness of a digital biomarker intervention called COMPASSION. The aim is to reduce hospital readmissions and improve patient outcomes by implementing evidence-based therapies and coordinated care. The study will involve monitoring patients' symptoms and treatment responses to optimize their care and minimize the risk of readmission. Participants will be recruited from multiple locations in Phoenix, Arizona.
Why it matters
Potential benefit: If successful, this approach could significantly reduce hospital readmissions and improve the quality of life for patients with heart failure and acute MI.
How similar studies have gone: Other studies have shown promise in reducing readmissions for heart failure patients through coordinated care and digital interventions, indicating that this approach may be effective.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: Men and women over 18 years of age are included. Eligible subjects must be hospitalized with a primary diagnosis of ADHF or acute MI. The diagnosis of HF is established by the presence of typical symptoms, signs, and objective evidence of pulmonary congestion, elevated BNP or N-terminal pro B-type natriuretic peptide (NT-pro BNP) or impaired cardiac function. Acute MI is diagnosed by presence of chest pain, arm pain, or dyspnea with elevated Troponin and/or EKG changes suggestive of Acute coronary syndrome requiring intervention or optimal medical therapy. Exclusion Criteria: 1. Study informed consent will be obtained before enrollment in the study for Phase 1 and Phase 2 2. All subjects 18 years or above will be a criteria for inclusion for Phase 1 3. For Phase 2, men and women 50 years or older with positive Covid19 antigen test and one other risk factor as mentioned in the comorbid section of workflow will be enrolled in the intervention arm of the study; 4. For phase 2, subjects should be able to be randomized within 48 hours of Covid19 antigen positive status 5. Patients considered unreliable by the investigator concerning the requirements for follow-up visits
Where it's running
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Multiple Locations
Phoenix, Arizona, United States Recruiting
Study contacts
- Principal investigator: Zaki Lababidi, MD — Gilbert Cardiology
- Study coordinator: Navin Govind
- Email: vitalbeat@aventyn.com
- Phone: 2317942328
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.