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NCT04154878 · ClinicalTrials.gov registry record
2 New Measurements Used to Describe the Filling Phase of the Left Ventricle (LV).
A clinical trial, sponsored by AdventHealth.
- Completed
- Registry status
- 111
- Enrollment target
NCT04154878: Completed study, sponsored by AdventHealth.
NCT04154878 is a clinical trial that has completed, run by AdventHealth. The registered enrollment target is 111 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04154878 has completed, sponsored by AdventHealth.
- COMPLETED
- Registry status
- 111 participants
- Enrollment target
Study Summary
As we live longer our population experiencing heart failure (HF) continues to grow consuming an increasing percent of healthcare dollars. Systolic heart failure or pump failure is easy to recognize and measure and is expressed as ejection fraction. Diastolic heart failure (DHF) or failure to fill adequately is much more difficult to quantify with no single measure or number being used to express the severity instead groupings are used with normal and Grade I, II or Grade III to classify with Grade III being the direst. Heart Failure with Reduced Ejection Fraction (HFrEF) and Heart Failure with Preserved Ejection Fraction (HFpEF) are used to identify the primary clinical presentation of HF but do not adequately describe the combined effect often presenting within the same subject. It is estimated 35 to 50% of those with HFrEF, having Left Ventricle Ejection Fraction (LVEF) \< 50%, and 50 to 70% of those with HFpEF, having ejection fraction ≥ 50%, also have moderate to severe diastolic dysfunction (DD). The purpose of this study is two fold. The first is to determine if the rate of change measured from the left ventricular inflow inspiratory phase Doppler waveform provides insight into a cause of diastolic heart failure by comparing echocardiographic data points obtained prior to and immediately following optimization of a bi-ventricular pacemaker. This HF population requires an ejection fraction of 35 percent or lower to qualify for the device. These echocardiograms have been previously completed and will be reanalyzed. The second purpose is to determine if relationships between different features of a LV volume curve can be used to generate a single number to describe global diastolic function using the same echocardiograms from the pacemaker group. Results will be compared to a small group of healthy normal participants as a control for validation.
Primary Outcome
Determine the LV Volume Classification based on the current American Society of Echocardiography classification method
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 111 participants |
| Start Date | 2019-10-30 |
| Est. Completion | 2023-06-21 |
What the finished NCT04154878 record still lists
NCT04154878 is an observational study that tracks outcomes without assigning an intervention. The registered 111 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT04154878 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04154878 about?
NCT04154878 is a clinical study titled "2 New Measurements Used to Describe the Filling Phase of the Left Ventricle (LV).". As we live longer our population experiencing heart failure (HF) continues to grow consuming an increasing percent of healthcare dollars. Systolic heart failure or pump failure is easy to recognize and measure and is expressed as ejection fraction. Diastolic heart failure (DHF) or failure to fill ad...
What is the current status of trial NCT04154878?
This trial is currently completed. The enrollment target is 111 participants. The study started on 2019-10-30. Estimated completion is 2023-06-21.
Who is sponsoring clinical trial NCT04154878?
This trial is sponsored by AdventHealth, which has 95 total clinical trials registered on ClinicalTrials.gov.
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