Improving outcomes for heart failure and acute myocardial infarction patients through care coordination
Care cOordination Using Mobile Technology to Enhance Patient Empowerment in Acute Comorbidities to aSSess Improvement in Outcomes in Hospital readmissioNs
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Aventyn, Inc. Industry-sponsored |
| Locations | 1 site (Phoenix, Arizona) |
| Trial ID | NCT04905160 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include men and women over 18 years old who are hospitalized with a primary diagnosis of ADHF or acute MI.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Phoenix, Arizona
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.