Patient SELF-management With HemodynamIc Monitoring: Virtual Heart Failure Clinic and Outcomes
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Chronic Heart Failure
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: This will be a single center, prospective, randomized, open-label blinded-endpoint (PROBE) trial in which the treatment group will be implanted with a CardioMEMS HF sensor and managed using remote access to hemodynamics compared to a non-implanted control group.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
This will be a single center, prospective, randomized, open-label blinded-endpoint (PROBE) trial in which the treatment group will be implanted with a CardioMEMS HF sensor and managed using remote access to hemodynamics compared to a non-implanted control group. Patients with at least one hospitaliz...
This will be a single center, prospective, randomized, open-label blinded-endpoint (PROBE) trial in which the treatment group will be implanted with a CardioMEMS HF sensor and managed using remote access to hemodynamics compared to a non-implanted control group. Patients with at least one hospitalization for HF (?1) in the previous year (12 months) will be randomized into two groups, regardless of LVEF: Usual care with the specialized multidisciplinary HF clinic team (Non-implanted Control) or Hemodynamic monitoring, less intense HF clinic follow-up, and remote follow-up by a nurse clinician and patient empowerment with access to the PAP data (CardioMEMS group). Primary and secondary endpoints will be compared between groups after 12 months of follow-up and within groups comparing baseline parameters with 12 month follow-up measurements.
Tracking Information
- NCT #
- NCT04441203
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Anique Ducharme Montreal Heart Institute Study Director: Jean Rouleau, MD Montreal Heart Institute