Status:
RECRUITING
Care Coordination to Assess Improvement in Outcomes in Hospital Readmissions
Lead Sponsor:
Aventyn, Inc.
Collaborating Sponsors:
TwinEpidemic
Arizona State University
Conditions:
Heart Failure
ADHF
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Heart failure is a syndrome that is defined by distinctive clinical, hemodynamic, and neurohormonal findings. HF represents a final common pathway for many different cardiovascular diseases, including...
Detailed Description
Heart failure patients are frequently hospitalized and have a high mortality rate and accounts for over 1 million hospital admissions yearly in the U.S. It is associated with a 2-year mortality rate o...
Eligibility Criteria
Inclusion
- 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
- Study informed consent will be obtained before enrollment in the study for Phase 1 and Phase 2
- All subjects 18 years or above will be a criteria for inclusion for Phase 1
- 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;
- For phase 2, subjects should be able to be randomized within 48 hours of Covid19 antigen positive status
- Patients considered unreliable by the investigator concerning the requirements for follow-up visits
Key Trial Info
Start Date :
February 18 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 22 2026
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT04905160
Start Date
February 18 2021
End Date
December 22 2026
Last Update
March 20 2024
Active Locations (1)
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1
Multiple Locations
Phoenix, Arizona, United States, 85016