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

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Age 18 years or older.
  • 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% or less based on last local measurement using echocardiography, multigated acquisition scan, computed tomography scanning, magnetic resonance imaging, or ventricular angiography†.
  • Planned discharge to home or other supported-care facility where patients are individually responsible for medication management.
  • *Acute HF does not need to be the only diagnosis or initial diagnosis used by the emergency room. The local team should confirm the patient has HF symptoms and is receiving acute HF treatments; the medical record does not need to list HF as the only diagnosis. Acute HF can coexist with other cardiovascular or pulmonary diagnoses, including atrial fibrillation, pneumonia, or chronic obstructive pulmonary disease. Patients originally admitted for elective procedures such as orthopedic surgeries or implantable cardioverter defibrillator implantation are not eligible for CONNECT-HF. 
  • †Last local LVEF measurement time frame is not defined in the protocol. Patients are eligible if the patient has a known reduced LVEF and is being treated for HF with reduced LVEF. If the reported LVEF includes a range (eg, 35­45% and 40­45%), then the patient can be enrolled if the team reviews the case and believes the patient has an LVEF of 40% or less and meets indication for HF with reduced EF therapies.

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.

‡Patients receiving chronic dialysis prior to the index admission are excluded. Patients with advanced kidney disease who receive only temporary dialysis during the hospitalization are still eligible.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

La Crosse, Wis.

Mayo Clinic principal investigator

Charles Cagin, D.O.

Closed for enrollment

Jacksonville, Fla.

Mayo Clinic principal investigator

Shahyar Gharacholou, M.D., M.S.

Closed for enrollment

More information

Publications

Publications are currently not available
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CLS-20347033

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