2 New Measurements Used to Describe the Filling Phase of the Left Ventricle (LV).

Diastolic Heart Failure Clinical Trial

— INDEX  

Official title:

Novel Echo Diastolic Measurements (Index)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04154878
• Other study ID #: 1384494
• Status: Completed
• 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
• 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:

The purpose of this study is to introduce novel measurements to improve the classification of ventricular diastolic performance.

There are 2 cohorts. Cohort 1 consists of 100 subjects who were referred and received echo guided biventricular pacemaker optimization. This retrospective component data is being retrieved to compare baseline and final cardiac performance measures. Comparisons will be made between Doppler and 3D echo diastolic and systolic markers. The Doppler diastolic markers will include D-E slope measuring the rate of pressure equalization between the left atrium (LA) and left ventricle (LV) during inspiration and expiration. MV VTI, the velocity time integral of the left ventricular inflow tract (LVIT) a surrogate measure for LV filling volume, averaging three consecutive complexes and minimal and maximal variability. TDI, tissue Doppler Imaging, when coupled with LVIT measures provides an estimation of left ventricular diastolic pressure. IRT, isovolemic relaxation time, an indicator of LA preload, S/D ratio, an indicator of LA compliance/pressure compared to pulmonary venous pressure. LAv, LA volume, a criteria for diastolic dysfunction grading. TRvmax, tricuspid regurgitation maximum velocity, used to estimate right ventricular systolic pressure. 3D measures will be obtained from the volume curve generated from the 3D full volume image acquisition. The 2 slopes being compared are the initial filling (R1) and intermediate filling (R2) rates of volume change over time or R1/R2. LV ejection fraction, diastolic filling time (DFT), ejection time (ET), heart rate (HR), initial filling time (IFT), and stroke volume (SV) are all being measured from the 3D volume curve.

Cohort 2 consists of normal healthy participants to serve as a comparison providing HF diseased state differentiation. All baseline measures performed in cohort 1 will be done for cohort 2.

Primary Objective/Aim/Goal/Hypothesis Hypothesis: To determine if LV volume curves can be used to generate a single number that globally describes diastolic function and identify relationship to current grouping algorithm.

Secondary Objective/Aim/Goal/Hypothesis Hypothesis: To determine if the pulse wave Doppler of the left ventricular inflow tract D-E slope measure and changes correlate with changes in diastolic performance of the LV.

Hypothesis: Does weighting of the volume curve analysis with various features of the curve such as stroke volume, initial filling volume, and initial filling volume percent provide greater sensitivity or specificity in differentiating diastolic performance.

Study Design: This study is a retrospective observational data analysis of echocardiographic images and Doppler waveforms comparing data between measurements and calculations taken at baseline and after final programming of biventricular pacemaker devices performed during a single visit. Additionally, the echo data from 5 normal healthy participants will be acquired during a single visit to establish normal values and demonstrate reproducibility.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: June 21, 2023
• Est. primary completion date: December 29, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 85 Years

Eligibility

Cohort 1

Inclusion Criteria:

1. Underwent pacemaker optimization at study location.

2. Pacemaker optimization between May 1, 2007 and August 16, 2015.

3. Heart rate less than 95 beats per minute.

Exclusion Criteria:

1. Missing Data Points.

2. Poor quality echo images.

3. Atrial fibrillation.

Cohort 2 Inclusion Criteria.

1. Considered in good cardiac condition.

2. Heart rate less than 90 beats per minute.

Exclusion Criteria

History of or treatment for:

1. Atrial fibrillation.

2. Coronary artery disease.

3. Heart Attack.

4. Pacemaker.

5. Cardiomyopathy.

6. Diabetes.

7. Kidney disease.

8. Hypertension. Systolic pressure > 140. Diastolic pressure > 90.

9. Lung disease.

10. Emphysema.

11. Bronchitis.

12. Asthma.

Withdrawal Criteria:

1. Poor quality echo images.

Related Conditions & MeSH terms

• Diastolic Heart Failure
• Heart Failure, Diastolic
• Left Ventricular Diastolic Collapse
• Left Ventricular Diastolic Dysfunction
• Ventricular Dysfunction, Left

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