Care Coordination to Assess Improvement in Outcomes in Hospital Readmissions
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.
Conditions:
🦠 Heart Failure 🦠 ADHF 🦠 Acute MI
🗓️ Study Start (Actual) 18 February 2021
🗓️ Primary Completion (Estimated) 22 February 2025
✅ Study Completion (Estimated) 22 December 2026
👥 Enrollment (Estimated) 1000
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Phoenix, Arizona, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 24 May 2021
  • First Submitted that Met QC Criteria 24 May 2021
  • First Posted 27 May 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 19 March 2024
  • Last Update Posted 20 March 2024
  • Last Verified March 2024