NCT04905160 Care Coordination to Assess Improvement in Outcomes in Hospital Readmissions
| NCT ID | NCT04905160 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Aventyn, Inc. |
| Condition | Heart Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2021-02-18 |
| Primary Completion | 2025-02-22 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,000 participants in total. It began in 2021-02-18 with a primary completion date of 2025-02-22.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 coronary disease, hypertension, Valvular disease, and many primary heart muscle diseases. Clinically, HF patients experience dyspnea, fatigue and diminished exercise tolerance, reflecting elevated left and/or right ventricular filling pressures and decreased cardiac output.
Eligibility 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
Contact & Investigator
Kris Vijay, MD
STUDY CHAIR
Abrazo Arizona Heart
Frequently Asked Questions
Who can join the NCT04905160 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04905160 currently recruiting?
Yes, NCT04905160 is actively recruiting participants. Contact the research team at vitalbeat@aventyn.com for enrollment information.
Where is the NCT04905160 trial being conducted?
This trial is being conducted at Phoenix, United States.
Who is sponsoring the NCT04905160 clinical trial?
NCT04905160 is sponsored by Aventyn, Inc.. The principal investigator is Kris Vijay, MD at Abrazo Arizona Heart. The trial plans to enroll 1,000 participants.
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