Care Optimization Through Patient and Hospital Engagement Clinical Trial for Heart Failure

ID#: NCT03035474

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: N/A

Recruitment Status: Recruiting

Start Date: April 21, 2017

End Date: July 01, 2020

Contact Information:
Melissa E Feren
Linda Davidson-Ray
Summary: CONNECT-HF is a large-scale, pragmatic, cluster-randomized clinical trial to evaluate the effect of a customized, multifaceted, health system-level quality-improvement (QI) program compared with usual care on heart failure (HF) outcomes and HF quality-of-care metrics.

Inclusion Criteria:

- Age ≥ 18 years

- Acute HF as a primary cause of hospitalization

- Hospitalizations for acute HF will be determined by local clinician-investigators but should include the following:

- Symptoms (eg, dyspnea, fatigue), signs (eg, elevated jugular venous pressure, peripheral edema), or laboratory/imaging evidence of HF (eg, pulmonary congestion on chest x-ray, elevated natriuretic peptide levels) during the hospitalization and

- Treatments aimed at acute HF (eg, intravenous diuretics, vasodilators, or inotropes)

- LVEF ≤ 40% based on last local measurement using echocardiography, multigated acquisition scan, computed tomography (CT) scanning, magnetic resonance imaging, or ventricular angiography

- Planned discharge to home or other supported care facility where patients are individually responsible for medication management

Exclusion Criteria:

- Prior heart transplant or current/planned left ventricular assistance device

- Chronic kidney disease requiring dialysis

- Terminal illness other than HF, such as malignancy, or with a life expectancy of less than 1 year as determined by the enrolling clinician-investigator

- Unable to participate in longitudinal follow-up, such as plans to move outside the US in the following year