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Patient SELF-management With HemodynamIc Monitoring: Virtual Heart Failure Clinic and Outcomes

Study acronym: SELFIe-HF
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated November 22, 2024 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Notable Primary completion date: Nov 2023 to Dec 2025
    • Study completion date: Jun 2024 to Dec 2025
    v4
  2. Minor Study sites: 2 to 1v3
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 2
    • Start date changed from estimate of Jul 2020 to May 4, 2020
    v2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
To demonstrate that a virtual Heart Failure Clinic (HFC) based on patient self-management using Pulmonary Artery Pressure (PAP) monitoring is superior to usual care of HFC, leads to decreased: hospital admissions for heart failure (HF), emergency department consultation and/or unplanned intravenous heart failure therapy and cardiovascular death, compared to a regular HFC, has low device-related complications and is cost-effective, in New York Heart Association (NYHA) class III and II (requiring diuretics) patients.
Trial Details
NCT Number NCT04441203
Lead Sponsor Montreal Heart Institute
Conditions
(from sponsor)
Chronic Heart Failure
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov