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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04154878
Recruitment Status : Recruiting
First Posted : November 7, 2019
Last Update Posted : November 7, 2019
Information provided by (Responsible Party):

Brief 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.

Condition or disease
Diastolic Heart Failure Left Ventricular Diastolic Dysfunction Left Ventricular Diastolic Collapse

Detailed 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.

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Study Type : Observational
Estimated Enrollment : 130 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Novel Echo Diastolic Measurements (Index)
Actual Study Start Date : October 30, 2019
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : July 2020

Pacemaker Optimization
Participants were referred for pacemaker optimization following implantation of a device. All had an intact atrial contraction either intrinsic or by device stimulation. A standard baseline echo was performed prior to programming changes with a final echo scan completed after all programming complete. Device programming consisted of adjusting atrial ventricular and right to left ventricular stimulation delays.
A brief cardiac history questionnaire and complete echocardiogram will be performed.

Primary Outcome Measures :
  1. LV Volume Curve Classification [ Time Frame: 9 months ]
    Determine the LV Volume Classification based on the current American Society of Echocardiography classification method

  2. D-E Slope [ Time Frame: 6 months ]
    Determine if the D-E Slope contributed additional information to diastolic function classification

Secondary Outcome Measures :
  1. LV Volume Curve Weighting of R1/R2 with SV, ET, IFV, DFT [ Time Frame: 9 months ]
    Determine if the use of various volume curve features improve sensitivity

  2. LV Volume Curve Weighting of R1/R2 with body mass indexed SV and IFV [ Time Frame: 9 months ]
    Determine if the use of various volume curve features improve sensitivity

  3. D-E Slope variability comparing minimum and maximum values measured during resting respirations [ Time Frame: 9 months ]
    Is resting D-E Slope variability comparing minimum and maximum values measured during resting respirations associated with diastolic dysfunction severity

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   45 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Cohort 1 participants are individuals who have received a baseline and final echocardiogram.

Cohort 2 is comprised of cardiac healthy participants.


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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04154878

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Contact: Richard J Moro, MBA 321.277.0607

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United States, Florida
AdventHealth Orlando Recruiting
Orlando, Florida, United States, 32803
Contact: Richard J Moro, MBA    321-277-0607   
Sponsors and Collaborators
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Responsible Party: AdventHealth Identifier: NCT04154878    
Other Study ID Numbers: 1384494
First Posted: November 7, 2019    Key Record Dates
Last Update Posted: November 7, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Failure, Diastolic
Heart Failure
Heart Diseases
Cardiovascular Diseases