Investigation of the Hemodynamic Cardiac Profiler in assessing cardiac indices and clinical performance during exercise and cardiac stress

Aim of this 3-phase study is to investigate the reproducibility and validity of the new Hemodynamic Cardiac Profiler (HCP) device in rest and exercise in healthy volunteers and in patients who succesfully completed cardiac rehabilitation and to investigate weather changes in SV as measured by HCP LVVTC are related to physical fitness.

Rationale: The assessment of hemodynamic indices is of interest to evaluate performance in athletes, changes in exercise capacity due to lifestyle interventions, and medical therapies in patients with ischemic heart disease. Current non-invasive options to measure cardiac output (CO) and stroke volume (SV) during exercise and cardiac stress include exercise-transthoracic echocardiography (X-TTE) and exercise-MRI. However, both these imaging modalities are expensive, highly complex, and are not readily available in all clinical settings. The Hemodynamic Cardiac Profiler device (HCP) has been shown to be reliably able to non-invasively track changes in left ventricular stroke volume in rest by producing left ventricle volume-time curves (LVVTC). However, the HCP has not been validated during exercise or cardiac stress. Furthermore, it is not known whether the measurements of HCP are related to other established (prognostic) measurements of cardiopulmonary fitness, such as cardiopulmonary exercise testing (CPX) (VO2peak and O2-pulse).
Objective: To investigate the reproducibility and validity of HCP in rest and exercise and to investigate whether changes in SV and CO as measured by HCP LVVTC are related to physical fitness.
Study design: The current study is a 3-phase, prospective reproducibility, validation and measurement pilot study.
Study population: Healthy volunteers > 18 years (phase 1 and 2), patients with stable ischemic heart disease and cardiac rehabilitation completed (phase 3).
Investigation: The HCP consists of 12 standard ECG-electrodes attached on the thorax in a pre-defined pattern, and uses low-intensity, patient-safe, high-frequent applied AC currents to measure LVVTCs.
Main study parameters/endpoints:
Phase 1: Intraclass correlation coefficient of the four measurements of changes in stroke volume slope using the HCP during CPX in healthy volunteers.
Phase 2: Intraclass correlation coefficient between the measurements of changes in stroke volume slope between the HCP and CPX and Pearson’s correlation coefficients between changes in stroke volume slope measured using the HCP and changes in O2-pulse and VO2max (CPX) in healthy volunteers.
Phase 3: Intraclass correlation coefficient between the measurements of changes in stroke volume slope between the HCP and CPX and Pearson’s correlation coefficients between changes in stroke volume slope measured using the HCP and changes in O2-pulse and VO2max (CPX) in individuals with stable ischemic heart disease.

Reproducibility and validity of the new Hemodynamic Cardiac Profiler (HCP) device in rest and exercise in healthy volunteers will be ICC > 0.60.

phase 1,2,3