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Use of Phenylephrine for Assessment of Mitral Regurgitation Severity

StatusRecruiting
PhasePhase 1/2
Started
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Record status
This record was last updated July 20, 2025 (before its estimated June 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Primary and study completion dates: Jun 2025 to Jun 2026
    • Collaborators expanded, about 4 words
    v7
  2. Primary and study completion dates: Jun 2024 to Jun 2025v6
  3. Primary and study completion dates: Jun 2023 to Jun 2024v5
  4. Primary completion date: Nov 2022 to Jun 2023
    • Study completion date: Dec 2022 to Jun 2023
    v4
  5. Primary completion date: Nov 2021 to Nov 2022
    • Study completion date: Dec 2021 to Dec 2022
    v3
  6. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Aug 2020 to Dec 1, 2020
    • Study sites: 0 to 1
    v2
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The study proposes to develop a phenylephrine protocol to be used during transesophageal echocardiography, whereby intravenous phenylephrine would be used to increase afterload with the intent to mimic the awake hemodynamic profile and variation that occurs with normal physical activity. The expectation is to see changes in severity of Mitral Regurgitation (MR) grade with increasing afterload, which in turn can provide more accurate quantification of MR severity to assist in clinical decision making.
Trial Details
NCT Number NCT04500899
Lead Sponsor Montefiore Medical Center
Collaborators: Baylor College of Medicine
Conditions
(from sponsor)		 Mitral Regurgitation
Related terms Mitral Valve Insufficiency
Enrollment 35 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov