INVESTIGATION OF THE HEMODYNAMIC CARDIAC PROFILER IN ASSESSING CARDIAC INDICES AND CLINICAL PERFORMANCE DURING EXERCISE AND CARDIAC STRESS

INVESTIGATION OF THE HEMODYNAMIC CARDIAC PROFILER IN ASSESSING CARDIAC INDICES AND CLINICAL PERFORMANCE DURING EXERCISE AND CARDIAC STRESS - Profiler study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON48698

Enrollment

Registered

2017-06-23

Start date

2017-09-21

Completion date

Unknown

Last updated

2024-07-22

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

Conditions

slechte inspannings intolerantie cardiac failure exercise intolerance

Interventions

Phase 1a Reproducibility: HCP during exercise (a total of 10 subjects) 4 conventional bike tests per subject 4 recumbent bike exercise tests per subject Phase 1b Validity:( a total of 40 subjects)

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Healthy volunteers (phases 1 and 2, MRI study) - >18 years of age - Informed consent , Patients with stable ischemic heart disease (phase 3, MRI study) - Informed consent - > 18 years - ischemic heart disease - cardiac rehabilitation completed

Exclusion criteria

Exclusion criteria: - symptomatic heart failure - unstable ischemic heart disease - planned coronary revascularization - any significant valve pathology (grade >2) - any right-sided structural pathology or reduced function (Tapse

Design outcomes

Primary

Measure	Time frame
Phase 1: Intraclass correlation coefficient between the four measurements of changes in stroke volume slope using the HCP during cardiopulmonary exercise testing (CPX). Phase 2: Intraclass correlation coefficient between the measurements of changes in stroke volume slope using the HCP during CPX and Pearsons correlation coefficients between changes in stroke volume slope measured using the HCP and changes in O2pulse and VO2max (CPX) in healthy volunteers. Phase 3: Intraclass correlation coefficient between the measurements of changes in stroke volume slope using the HCP during CPX and Pearsons correlation coefficients between changes in stroke volume slope measured using the HCP and changes in O2pulse and VO2max (CPX) in patients with stable ischemic heart disease. Additional MRI study: Intraclass correlation coefficient between the measurements of stroke volume between the HCP and MRI per data point in the volume-time curve.	—

Measure

Time frame

Phase 1: Intraclass correlation coefficient between the four measurements of changes in stroke volume slope using the HCP during cardiopulmonary exercise testing (CPX). Phase 2: Intraclass correlation coefficient between the measurements of changes in stroke volume slope using the HCP during CPX and Pearson*s correlation coefficients between changes in stroke volume slope measured using the HCP and changes in O2pulse and VO2max (CPX) in healthy volunteers. Phase 3: Intraclass correlation coefficient between the measurements of changes in stroke volume slope using the HCP during CPX and Pearson*s correlation coefficients between changes in stroke volume slope measured using the HCP and changes in O2pulse and VO2max (CPX) in patients with stable ischemic heart disease. Additional MRI study: Intraclass correlation coefficient between the measurements of stroke volume between the HCP and MRI per data point in the volume-time curve.

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Secondary

Measure	Time frame
Secondary study parameters/endpoints (if applicable) - The association between E/A ratio as measured during exercise X-TTE with diastolic parameters derived from the HCP (Volume change during early filling phase / Volume change during late filling phase = Ev/Av) - Resting and exercise echocardiographic parameters, in particular SV and CO as measured using VTI (additionally, LV/RF dimensions and function, valve function, LV diastolic function, VCI diameter, dp/dt) and its association with relevant HCP parameters. MRI study o The reproducibility of LVVTC produced by HCP. o Stroke volume variations between HCP and MRI Other study parameters (if applicable) 1. HCP parameters: - Time of systole/ diastole (S/D-ratio = tSystole/tDiastole) - Left-ventricular ejection time (LVET [ms]) 2. V02peak (absolute, indexed for gender, age, body mass or lean body mass) and O2pulse (and other relevant parameters, such as VE/VCO2 slope) 3. The association between self-reported physical activity (SQUASH-questionnaire), VO2peak, and max levels of exercise (watts, METS, duration). 4. Hb and Ht using finger prick	—

Measure

Time frame

Secondary study parameters/endpoints (if applicable) - The association between E/A ratio as measured during exercise X-TTE with diastolic parameters derived from the HCP (Volume change during early filling phase / Volume change during late filling phase = Ev/Av) - Resting and exercise echocardiographic parameters, in particular SV and CO as measured using VTI (additionally, LV/RF dimensions and function, valve function, LV diastolic function, VCI diameter, dp/dt) and its association with relevant HCP parameters. MRI study o The reproducibility of LVVTC produced by HCP. o Stroke volume variations between HCP and MRI Other study parameters (if applicable) 1. HCP parameters: - Time of systole/ diastole (S/D-ratio = tSystole/tDiastole) - Left-ventricular ejection time (LVET [ms]) 2. V02peak (absolute, indexed for gender, age, body mass or lean body mass) and O2pulse (and other relevant parameters, such as VE/VCO2 slope) 3. The association between self-reported physical activity (SQUASH-questionnaire), VO2peak, and max levels of exercise (watts, METS, duration). 4. Hb and Ht using finger prick

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)