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

NCT04154878 | Completed

• 1 other identifier: 1384494
• Study Type: observational
• Target: 111
• Locations: 1 country
• Sites: 1

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.

Conditions

Diastolic Heart Failure; Left Ventricular Diastolic Dysfunction; Left Ventricular Diastolic Collapse

Outcome Measures

Primary Outcomes (2)

• LV Volume Curve Classification

  Determine the LV Volume Classification based on the current American Society of Echocardiography classification method

  9 months

• D-E Slope

  Determine if the D-E Slope contributed additional information to diastolic function classification

  6 months

Secondary Outcomes (3)

• LV Volume Curve Weighting of R1/R2 with SV, ET, IFV, DFT

  9 months

• LV Volume Curve Weighting of R1/R2 with body mass indexed SV and IFV

  9 months

• D-E Slope variability comparing minimum and maximum values measured during resting respirations

  9 months

Study Arms (2)

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.

Healthy

A brief cardiac history questionnaire and complete echocardiogram will be performed.

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Underwent pacemaker optimization at study location.
• Pacemaker optimization between May 1, 2007 and August 16, 2015.
• Heart rate less than 95 beats per minute.

You may not qualify if:

• Missing Data Points.
• Poor quality echo images.
• Atrial fibrillation.
• Considered in good cardiac condition.
• Heart rate less than 90 beats per minute.
• History of or treatment for:
• Atrial fibrillation.
• Coronary artery disease.
• Heart Attack.
• Pacemaker.
• Cardiomyopathy.
• Diabetes.
• Kidney disease.
• Hypertension. Systolic pressure \> 140. Diastolic pressure \> 90.
• Lung disease.

Sponsors & Collaborators

• AdventHealth: lead

Study Sites (1)

AdventHealth Orlando

Orlando, Florida, 32803, United States

Location

Related Publications (4)

• 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.

  PMID: 19187853 BACKGROUND

• 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.

  PMID: 27037982 BACKGROUND

• 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.

  PMID: 21772012 BACKGROUND

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

  BACKGROUND

MeSH Terms

Conditions

Heart Failure, Diastolic; Ventricular Dysfunction, Left

Condition Hierarchy (Ancestors)

Heart Failure; Heart Diseases; Cardiovascular Diseases; Ventricular Dysfunction

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2019
• First Posted: November 7, 2019
• Study Start: October 30, 2019
• Primary Completion: December 29, 2020
• Study Completion: June 21, 2023
• Last Updated: June 29, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)