Trial Outcomes & Findings for Radiofrequency-based Speckle Tracking Echocardiography to Evaluate Diastolic Function (NCT NCT01182805)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

50 participants

Primary outcome timeframe

Assessed from echo obtained at time of enrollment

Results posted on

2023-10-16

Participant Flow

Participant milestones

Participant milestones
Measure	All Study Participants All study participants underwent measurement of Diastolic Circumferential Strain Rate during Isovolumic Relaxation as well as measurement of E-prime by tissue Doppler. They also all had evaluation of their diastolic function by the combination of their mitral inflow pattern and invasive measure of left ventricular end-diastolic pressure.
Overall Study STARTED	50
Overall Study COMPLETED	50
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Radiofrequency-based Speckle Tracking Echocardiography to Evaluate Diastolic Function

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single Arm Study. n=50 Participants
Age, Continuous	59 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants
Region of Enrollment United States	50 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Normal Diastolic Function n=7 Participants These were the subjects deemed to have normal diastolic function using the gold standard assessment of mitral inflow and LV end-diastolic pressure (E/A 1 - 2 and LVEDP \<= 15 mm Hg).	Grade 1 Diastolic Dysfunction n=12 Participants These were the subjects deemed to have Grade 1 diastolic dysfunction using the gold standard assessment of mitral inflow and LV end-diastolic pressure (E/A \< 1.0).	Grade 2 Diastolic Dysfunction n=7 Participants These were the subjects deemed to have Grade 2 diastolic dysfunction using the gold standard assessment of mitral inflow and LV end-diastolic pressure (E/A 1 - 2 and LVEDP \> 15 mm Hg).
Diastolic Circumferential Strain Rate During Isovolumic Relaxation	0.61 1/sec Standard Deviation 0.21	0.37 1/sec Standard Deviation 0.19	0.34 1/sec Standard Deviation 0.12

PRIMARY outcome

Timeframe: 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.

E-prime is a conventional commonly-used parameter of diastolic function. Higher values of E-prime typically reflect better diastolic function.

Outcome measures

Outcome measures
Measure	Normal Diastolic Function n=7 Participants These were the subjects deemed to have normal diastolic function using the gold standard assessment of mitral inflow and LV end-diastolic pressure (E/A 1 - 2 and LVEDP \<= 15 mm Hg).	Grade 1 Diastolic Dysfunction n=11 Participants These were the subjects deemed to have Grade 1 diastolic dysfunction using the gold standard assessment of mitral inflow and LV end-diastolic pressure (E/A \< 1.0).	Grade 2 Diastolic Dysfunction n=7 Participants These were the subjects deemed to have Grade 2 diastolic dysfunction using the gold standard assessment of mitral inflow and LV end-diastolic pressure (E/A 1 - 2 and LVEDP \> 15 mm Hg).
Early Diastolic Mitral Annular Velocity (E-prime) Using Tissue Doppler	8.1 cm/sec Standard Deviation 1.9	5.6 cm/sec Standard Deviation 1.7	7.0 cm/sec Standard Deviation 1.8

Adverse Events

Single Arm Study.

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Theodore J. Kolias, MD

University of Michigan

Phone: (734) 615-4907

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60