Recruiting

Community Paramedic

Sponsor:

Mayo Clinic

Code:

NCT06874556

Conditions

Heart Failure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CP-HF Management

Study Details

Brief summary:

The purpose of this research is to see if having community paramedic (CP) visit patients at home to manage their heart failure help them stay out of the hospital and improve their overall health compared to standard care. The investigators want to find out if their approach is better for patients in terms of their quality of life, hospital stays, emergency visits, and cost. The investigators are also looking to see how happy patients and doctors are with this method and if it's a practical and sustainable option for the future.

Conditions

Heart Failure

Study ID

NCT06874556

Start date

Jun 24, 2025

Status verified date

Apr, 2026

Completion date

Jan, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

One of the following criteria:

1. Adults admitted to the hospital with decompensated HF eligible for early discharge with CP support and monitoring.
2. Acutely decompensated HF patients at home or being evaluated in the ambulatory clinic who require large volume diuresis but do not require hospital-level monitoring.
3. Stage D advanced HF patients who require frequent (>weekly) diuretic adjustments (either inpatient or outpatients).

Exclusion Criteria:

1. Hospital-level monitoring or care is clinically indicated.
2. Failed safety assessment, active substance abuse, or behavioral health diagnosis which could impact participation.
3. Enrolled in hospice.
4. Patient is a resident in a skilled nursing facility.
5. Patient does not have a primary care physician or cardiologist at Mayo Clinic.
6. Patient participants with communication barriers due to medical illness or cognitive impairment.
7. Pregnant

Study Design

Enrollment

75 participants

Anticipated

Interventions and Outcome Measures

Arms

Community Paramedic Heart Failure Management (CP-HF) program

Standard of Care (SOC)

Interventions

CP-HF Management

Community Paramedics will visit patients up to twice daily. Visits will include patient care discussion with Heart Failure APP, IV placement, lab phlebotomy, heart failure education, and IV medication administration. Community Paramedics will administer up to 120 mg IV furosemide twice daily.

Primary outcome measure

  • Number of Days without Hospitalization [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 12 months ]
  • Number of Days in the Hospital [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 12 months ]
  • Number of Emergency Department (ED) Visits [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 12 months ]
  • Number of Hospitalizations [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 12 months ]
  • Minnesota Living with Heart Failure Questionnaire (MLHFQ) [ Time Frame: Baseline, 31 Days ]
  • Number of patients to comply with the guideline-directed medical therapy (GDMT) [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 12 months ]

Central Contacts and Locations

Central contacts

Sara Biorn

507-266-2328Biorn.Sara@mayo.edu

Locations

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

More Information

Sponsor

Mayo Clinic

Last update posted

Apr 16, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-04-16.