Heart Failure, Diastolic
Conditions
Brief summary
The purpose of this study is to evaluate a novel ultrasound system's ability to assess the relaxing properties of the heart compared to current techniques.
Interventions
DEVICEEchocardiography system Ultra DCI Model 5000
Each subject will undergo scanning using the investigational echocardiography system (Ultra DCI Model 5000)to measure Diastolic Circumferential Strain Rate during Isovolumic Relaxation (DCSR-IVR) as novel measure of diastolic function.
DEVICEEchocardiography machine GE Vivid E9
Each subject will undergo echocardiography using a conventional echocardiography machine to evaluate the early diastolic mitral annular velocity (E-prime) using tissue Doppler as a standard measure of diastolic function.
Each subject will undergo standard echocardiographic measure of the mitral inflow pattern and invasive catheter-derived measure of left ventricular end-diastolic pressure to determine their diastolic function. This evaluation will be used as the gold standard for this study.
Sponsors
Pixel Velocity, Inc. / Epsilon Imaging
National Heart, Lung, and Blood Institute (NHLBI)
University of Michigan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients scheduled to undergo a clinically indicated left heart cardiac catheterization will be recruited for the study.
Exclusion criteria
* Suspected acute ST elevation myocardial infarction. * Acute coronary syndrome with active ongoing chest pain * Known or suspected acute aortic dissection * Known or suspected cardiac tamponade * Known history of unoperated constrictive pericarditis * Known or suspected severe aortic stenosis or severe mitral regurgitation * Heart rhythm other than sinus rhythm on pre-cath EKG * Age \< 18 years old * Unable to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diastolic Circumferential Strain Rate During Isovolumic Relaxation | Assessed from echo obtained at time of enrollment | Diastolic circumferential strain rate during isovolumic relaxation is a novel measure of diastolic function that measures the rate of relaxation of the left ventricle during the interval of isovolumic relaxation (the period of active relaxation). We would expect that a higher value reflects better relaxation, and better diastolic function. |
| Early Diastolic Mitral Annular Velocity (E-prime) Using Tissue Doppler | Assessed from echo obtained at time of enrollment | E-prime is a conventional commonly-used parameter of diastolic function. Higher values of E-prime typically reflect better diastolic function. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Single Arm Study. | 50 |
| Total | 50 |
Baseline characteristics
| Characteristic | Single Arm Study. |
|---|---|
| Age, Continuous | 59 years STANDARD_DEVIATION 10 |
| Region of Enrollment United States | 50 participants |
| Sex: Female, Male Female | 26 Participants |
| Sex: Female, Male Male | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 |
Outcome results
Primary
Diastolic Circumferential Strain Rate During Isovolumic Relaxation
Diastolic circumferential strain rate during isovolumic relaxation is a novel measure of diastolic function that measures the rate of relaxation of the left ventricle during the interval of isovolumic relaxation (the period of active relaxation). We would expect that a higher value reflects better relaxation, and better diastolic function.
Time frame: Assessed from echo obtained at time of enrollment
Population: Only 26 subjects had adequate images for assessment of DCSR-IVR and had gold standard assessment of diastolic function, and the analysis was limited to these subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Normal Diastolic Function | Diastolic Circumferential Strain Rate During Isovolumic Relaxation | 0.61 1/sec | Standard Deviation 0.21 |
| Grade 1 Diastolic Dysfunction | Diastolic Circumferential Strain Rate During Isovolumic Relaxation | 0.37 1/sec | Standard Deviation 0.19 |
| Grade 2 Diastolic Dysfunction | Diastolic Circumferential Strain Rate During Isovolumic Relaxation | 0.34 1/sec | Standard Deviation 0.12 |
Primary
Early Diastolic Mitral Annular Velocity (E-prime) Using Tissue Doppler
E-prime is a conventional commonly-used parameter of diastolic function. Higher values of E-prime typically reflect better diastolic function.
Time frame: Assessed from echo obtained at time of enrollment
Population: Only 25 subjects had adequate images for assessment of DCSR-IVR and interpretable tissue Doppler and gold standard assessment of diastolic function, and the analysis was limited to these subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Normal Diastolic Function | Early Diastolic Mitral Annular Velocity (E-prime) Using Tissue Doppler | 8.1 cm/sec | Standard Deviation 1.9 |
| Grade 1 Diastolic Dysfunction | Early Diastolic Mitral Annular Velocity (E-prime) Using Tissue Doppler | 5.6 cm/sec | Standard Deviation 1.7 |
| Grade 2 Diastolic Dysfunction | Early Diastolic Mitral Annular Velocity (E-prime) Using Tissue Doppler | 7.0 cm/sec | Standard Deviation 1.8 |