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NCT03923530 · ClinicalTrials.gov registry record · Early Phase 1
Pressure Assessment to Improve Outcomes After TAVR: a Registry
A Early Phase 1 study of Hypertension and Quality of Life, sponsored by North Florida Foundation for Research and Education.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT03923530 is a Early Phase 1 study of Hypertension and Quality of Life that has completed, run by North Florida Foundation for Research and Education. The registered enrollment target is 12 participants, below the 3,507-participant average among 470 other Hypertension trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03923530, a Early Phase 1 study of Hypertension and Quality of Life, has completed, sponsored by North Florida Foundation for Research and Education.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study Summary
At the Malcom Randall Veterans Affairs Medical Center (MRVAMC), invasive cardiac pressures are routinely recorded after transcatheter aortic valve replacement (TAVR) procedures. Our research has disclosed that patients with abnormal hemodynamics (narrow aortic to ventricular end-diastolic pressure difference, indexed to heart rate) suffer from high long-term mortality, compared with patients with normal hemodynamics.This hemodynamic value can be referred to as the aortoventricular index (AVi). Hypertension and diastolic dysfunction are highly co-morbid conditions among these patients. The selective aldosterone receptor antagonist eplerenone (Inspra) is approved for use in the treatment of hypertension. Research also supports that eplerenone may be able to improve diastolic function. This prospective study is interested in determining 1) the tolerability of eplerenone, and 2) feasibility of administering the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) among subject with abnormal cardiac hemodynamics after TAVR. This study will set the stage for a pilot randomized trial to evaluate eplerenone versus placebo among patients with abnormal hemodynamics after TAVR.
Conditions Studied
Interventions
- DRUG Eplerenone
Study Locations (1)
Florida
- Malcom Randall VA Medical Center - Gainesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2019-06-03 |
| Est. Completion | 2020-02-27 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03923530
The ClinicalTrials.gov registry entry for NCT03923530 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,507-participant average among 470 other Hypertension trials with a reported enrollment target (100% lower). The listed sponsor is North Florida Foundation for Research and Education, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Hypertension appearing as the primary indexed condition, and to 1 intervention - of which Eplerenone is the first listed.
NCT03923530 reports 1 study location spanning 1 distinct geographic area - top geographies include Florida.
Frequently Asked Questions
What is clinical trial NCT03923530 about?
NCT03923530 is a clinical study titled "Pressure Assessment to Improve Outcomes After TAVR: a Registry". At the Malcom Randall Veterans Affairs Medical Center (MRVAMC), invasive cardiac pressures are routinely recorded after transcatheter aortic valve replacement (TAVR) procedures. Our research has disclosed that patients with abnormal hemodynamics (narrow aortic to ventricular end-diastolic pressure d...
What is the current status of trial NCT03923530?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 12 participants. The study started on 2019-06-03. Estimated completion is 2020-02-27.
What conditions does trial NCT03923530 study?
This clinical trial studies the following conditions: Hypertension, Quality of Life, Heart Failure With Preserved Ejection Fraction, Aortic Stenosis, Calcific.
What interventions are being tested in trial NCT03923530?
The interventions under investigation include: Eplerenone (DRUG).
Who is sponsoring clinical trial NCT03923530?
This trial is sponsored by North Florida Foundation for Research and Education, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03923530 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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