LV flow patterns in systolic heart failure: A new aspect elucidated by high-frame rate echocardiography (PHRAsE study)

LV flow patterns in systolic heart failure: A new aspect elucidated by high-frame rate echocardiography (PHRAsE study) - LV flow pattern with HF rate echocardiography

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON50390

Enrollment

120

Registered

2018-05-04

Start date

2018-07-11

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

heart failure systolic dysfunction

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: * aged * 18 years; * capable of understanding and signing informed consent. * Patients with known heart failure with or without CRT, or heart valve pathology * Sub-study: 30 patients with heart failure and no CRT who also undergo cardiac MRI for clinical routine

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: * Patients living abroad or who are not Dutch speaking. * Any contra-indication for contrast media Sonovue (Bracco International bv, Amsterdam). * Patients with significant ventricular arrhythmia, acute coronary syndrome, or coronary revascularization within 6 months before CRT are excluded * Patients with inability to obtain adequate echocardiographic examination will be excluded. * Patients with a contraindication for MRI (i.e. claustrophobia) or contrast agent (eGFR

Design outcomes

Primary

Measure	Time frame
Main study parameter/endpoint The main study parameter/endpoint is the difference in LV flow pattern in LV systolic heart failure, which will be determined with contrast and high-frame rate echocardiography. We expect, based on earlier literature reports [Abe et al. Contrast echocardiography for assessing left ventricular vortex strength in heart failure: a prospective cohort study, European Heart Journal * Cardiovascular Imaging (2013) 14, 10491060; doi:10.1093/ehjci/jet049 ] that the LV flow will have different vorticity (which is a measure of rotational velocity and size of the vortex) dependent on cardiac function. The above study had limited framerate which reduced accuracy of the blood flow tracking, especially during the fast inflow in early diastole. We will use 5-fold larger frame rate which ensures correct flow tracking during the entire cardiac cycle [Voorneveld et al., Validation of high frame rate echo-PIV with optical PIV in a realistic left ventricular phantom*, Abstract IUS 2017].	—

Measure

Time frame

Main study parameter/endpoint The main study parameter/endpoint is the difference in LV flow pattern in LV systolic heart failure, which will be determined with contrast and high-frame rate echocardiography. We expect, based on earlier literature reports [Abe et al. *Contrast echocardiography for assessing left ventricular vortex strength in heart failure: a prospective cohort study*, European Heart Journal * Cardiovascular Imaging (2013) 14, 1049*1060; doi:10.1093/ehjci/jet049 ] that the LV flow will have different vorticity (which is a measure of rotational velocity and size of the vortex) dependent on cardiac function. The above study had limited framerate which reduced accuracy of the blood flow tracking, especially during the fast inflow in early diastole. We will use 5-fold larger frame rate which ensures correct flow tracking during the entire cardiac cycle [Voorneveld et al., *Validation of high frame rate echo-PIV with optical PIV in a realistic left ventricular phantom*, Abstract IUS 2017].

—

Secondary

Measure	Time frame
Secondary study parameters/endpoints include: - Changes in LV flow pattern before and after CRT [Goliasch et al., CRT Improves LV Filling Dynamics, JACC Cardiocascular imaging Vol. 6, NO. 6, 2013, doi: 10.1016/J.jcmg.2013.04.004] - Changes in LV flow patterns in non- and responders of CRT - Changes in LV flow velocity before and after CRT - Feasibility of LV myocardial perfusion with contrast and high-frame rate echocardiography	—

Measure

Time frame

Secondary study parameters/endpoints include: - Changes in LV flow pattern before and after CRT [Goliasch et al., *CRT Improves LV Filling Dynamics*, JACC Cardiocascular imaging Vol. 6, NO. 6, 2013, doi: 10.1016/J.jcmg.2013.04.004] - Changes in LV flow patterns in non- and responders of CRT - Changes in LV flow velocity before and after CRT - Feasibility of LV myocardial perfusion with contrast and high-frame rate echocardiography

—

Countries

Netherlands

Outcome results