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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04154878
Other study ID # 1384494
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 30, 2019
Est. completion date June 21, 2023

Study information

Verified date June 2023
Source AdventHealth
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

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Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States AdventHealth Orlando Orlando Florida

Sponsors (1)

Lead Sponsor Collaborator
AdventHealth

Country where clinical trial is conducted

United States, 

References & Publications (4)

4. Richard J. Moro, US Patent Application Publication US 2014/0275976 A1, Sep 18, 2014

Nagueh SF, Appleton CP, Gillebert TC, Marino PN, Oh JK, Smiseth OA, Waggoner AD, Flachskampf FA, Pellikka PA, Evangelista A. Recommendations for the evaluation of left ventricular diastolic function by echocardiography. J Am Soc Echocardiogr. 2009 Feb;22(2):107-33. doi: 10.1016/j.echo.2008.11.023. No abstract available. — View Citation

Nagueh SF, Smiseth OA, Appleton CP, Byrd BF 3rd, Dokainish H, Edvardsen T, Flachskampf FA, Gillebert TC, Klein AL, Lancellotti P, Marino P, Oh JK, Popescu BA, Waggoner AD. Recommendations for the Evaluation of Left Ventricular Diastolic Function by Echocardiography: An Update from the American Society of Echocardiography and the European Association of Cardiovascular Imaging. J Am Soc Echocardiogr. 2016 Apr;29(4):277-314. doi: 10.1016/j.echo.2016.01.011. No abstract available. — View Citation

Oh JK, Park SJ, Nagueh SF. Established and novel clinical applications of diastolic function assessment by echocardiography. Circ Cardiovasc Imaging. 2011 Jul;4(4):444-55. doi: 10.1161/CIRCIMAGING.110.961623. No abstract available. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary LV Volume Curve Classification Determine the LV Volume Classification based on the current American Society of Echocardiography classification method 9 months
Primary D-E Slope Determine if the D-E Slope contributed additional information to diastolic function classification 6 months
Secondary LV Volume Curve Weighting of R1/R2 with SV, ET, IFV, DFT Determine if the use of various volume curve features improve sensitivity 9 months
Secondary LV Volume Curve Weighting of R1/R2 with body mass indexed SV and IFV Determine if the use of various volume curve features improve sensitivity 9 months
Secondary D-E Slope variability comparing minimum and maximum values measured during resting respirations Is resting D-E Slope variability comparing minimum and maximum values measured during resting respirations associated with diastolic dysfunction severity 9 months
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