Diastolic Heart FailureINDEXNCT04154878
2 New Measurements Used to Describe the Filling Phase of the Left Ventricle (LV).
An observational study of Diastolic Heart Failure and Left Ventricular Diastolic Dysfunction, run by AdventHealth at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 45 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Diastolic Heart Failure, Left Ventricular Diastolic Dysfunction, Left Ventricular Diastolic Collapse
- How many people
- 111 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Oct 2019to 21 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Cohort 1 participants are individuals who have received a baseline and final echocardiogram. Cohort 2 is comprised of cardiac healthy participants.
Who may be able to join
- Underwent pacemaker optimization at study location.
- Pacemaker optimization between May 1, 2007 and August 16, 2015.
- Heart rate less than 95 beats per minute.
Who cannot join
- Missing Data Points.
- Poor quality echo images.
- Atrial fibrillation.
- Cohort 2 Inclusion Criteria.
- Considered in good cardiac condition.
- Heart rate less than 90 beats per minute.
Show all 21Show fewer
- 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.
- Emphysema.
- Bronchitis.
- Asthma.
- Withdrawal Criteria:
- 1. Poor quality echo images.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Novel Echo Diastolic Measurements (Index)
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).
Read more
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.
Read the 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.
- Conditions
- Diastolic Heart Failure, Left Ventricular Diastolic Dysfunction, Left Ventricular Diastolic Collapse
- Medical subject headings
- Heart Failure, Diastolic, Ventricular Dysfunction, Left
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
LV Volume Curve Classification
Determine the LV Volume Classification based on the current American Society of Echocardiography classification method
Measured: 9 months
D-E Slope
Determine if the D-E Slope contributed additional information to diastolic function classification
Measured: 6 months
Secondary outcomes (3)
LV Volume Curve Weighting of R1/R2 with SV, ET, IFV, DFT
Determine if the use of various volume curve features improve sensitivity
Measured: 9 months
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
Measured: 9 months
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
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2019
- Study start30 Oct 2019
- Primary completion29 Dec 2020
- Study completion21 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Diastolic Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- AdventHealth
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04154878
- Sponsor's protocol ID
- 1384494
- Acronym
- INDEX
- Status last verified
- Jun 2023
- First submitted
- 31 Oct 2019
- Last updated
- 29 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 19187853Nagueh 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.
PubMed 27037982Oh 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.
PubMed 217720124. Richard J. Moro, US Patent Application Publication US 2014/0275976 A1, Sep 18, 2014
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Echo Diastolic Measurements (Index)
- ClinicalTrials.gov ID
- NCT04154878
- Acronym / sponsor ID
- INDEX / 1384494
- Conditions
- Diastolic Heart Failure, Left Ventricular Diastolic Dysfunction, Left Ventricular Diastolic Collapse
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- AdventHealthUniversity, hospital or other
- Study start
- 30 Oct 2019 (actual)
- Primary completion
- 29 Dec 2020 (actual)
- Study completion
- 21 Jun 2023 (actual)
- First posted
- 7 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Cohort 1 participants are individuals who have received a baseline and final echocardiogram. Cohort 2 is comprised of cardiac healthy participants.
Key inclusion criteria (3 listed)
- Underwent pacemaker optimization at study location.
- Pacemaker optimization between May 1, 2007 and August 16, 2015.
- Heart rate less than 95 beats per minute.
Key exclusion criteria (21 listed)
- Missing Data Points.
- Poor quality echo images.
- Atrial fibrillation.
- Cohort 2 Inclusion Criteria.
- Considered in good cardiac condition.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
LV Volume Curve Classification
Time frame: 9 months
Determine the LV Volume Classification based on the current American Society of Echocardiography classification method
D-E Slope
Time frame: 6 months
Determine if the D-E Slope contributed additional information to diastolic function classification
3 secondary outcomes
LV Volume Curve Weighting of R1/R2 with SV, ET, IFV, DFT
Time frame: 9 months
LV Volume Curve Weighting of R1/R2 with body mass indexed SV and IFV
Time frame: 9 months
D-E Slope variability comparing minimum and maximum values measured during resting respirations
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2023.
- Background: PubMed 19187853Nagueh 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.
- Background: PubMed 27037982Nagueh 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.
- Background: PubMed 21772012Oh 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.
- Background4. Richard J. Moro, US Patent Application Publication US 2014/0275976 A1, Sep 18, 2014
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diastolic Heart Failure and Left Ventricular Diastolic Dysfunction, run by AdventHealth at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LV Volume Curve Classification (time frame: 9 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04154878, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2023.