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NCT04500899 · ClinicalTrials.gov registry record · Phase 1
Use of Phenylephrine for Assessment of Mitral Regurgitation Severity
A Phase 1 study of Mitral Regurgitation, sponsored by Montefiore Medical Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 35
- Enrollment target
- 1
- Study location
NCT04500899: Recruiting Phase 1 study of Mitral Regurgitation, sponsored by Montefiore Medical Center.
NCT04500899 is a Phase 1 study of Mitral Regurgitation that is actively recruiting participants, run by Montefiore Medical Center. The registered enrollment target is 35 participants, below the 1,023-participant average among 26 other Mitral Regurgitation trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04500899, a Phase 1 study of Mitral Regurgitation, is actively recruiting participants, sponsored by Montefiore Medical Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 35 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
The purpose of this study is to compare the echocardiographic parameters of MR grade before and after the use of phenylephrine during transesophageal echocardiography (TEE) and to document an increase in echocardiographic parameters of MR grade after the use of phenylephrine.
Conditions Studied
Interventions
- DRUG Mydfrin
Study Locations (1)
New York
- Montefiore Medical Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2020-12-01 |
| Est. Completion | 2026-06 |
| Phase | Phase 1 |
What NCT04500899 shows while recruiting
NCT04500899 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 1,023-participant average among 26 other Mitral Regurgitation trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Mitral Regurgitation appearing as the primary indexed condition, and to 1 intervention - of which Mydfrin is the first listed.
NCT04500899 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT04500899 about?
NCT04500899 is a clinical study titled "Use of Phenylephrine for Assessment of Mitral Regurgitation Severity". 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 expecta...
What is the current status of trial NCT04500899?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 35 participants. The study started on 2020-12-01. Estimated completion is 2026-06.
What conditions does trial NCT04500899 study?
This clinical trial studies the following conditions: Mitral Regurgitation.
What interventions are being tested in trial NCT04500899?
The interventions under investigation include: Mydfrin (DRUG).
Who is sponsoring clinical trial NCT04500899?
This trial is sponsored by Montefiore Medical Center, which has 345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04500899 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04500899's enrollment target sits among peer trials
35 21st of 26 higher than 6 of 26 other Mitral Regurgitation trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Mitral Regurgitation trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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