Cardiovascular Diseases
Conditions
Keywords
To assess two new diagnostic devices for detecting early Heart Failure.
Brief summary
This study will be testing two devices which are designed to detect cardiovascular disease in patients as early as possible. As there are now many therapies to prevent and treat this condition it is believed that detecting it early will help reduce the burden of the disease and permit more effective treatment. The two devices the investigators are testing are the ViScope developed by HD Medical and a device developed by CSIRO. Both of these devices are simple, non-invasive and may provide useful information on how well the heart contracts and relaxes as well as valve function of the heart. The investigators are planning to enroll 100 healthy subjects, 100 participants with risk factors for heart failure and 300 patients with varying types of heart failure. The data collected from the experimental devices will be compared to the results from standard tests. Patients will not have any of their therapies altered as part of this study.
Interventions
DEVICEHD medical device (ViScope)
Device
DEVICECSIRO device
device
Sponsors
HD Medical Group Ltd
Prof Henry Krum
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Over 18 years * Have provided consent Risk factor patients also require: * Hypertension \> 2 years * Diabetes \> 2 years * Known ischemia, TIA, or stroke * Arrhythmia; or reduced renal function (eGFR\<50 ml/min) Heart Failure patients also require: * LVEF \<40% * Receiving standard medication for the treatment of symptomatic systolic heart failure with an NYHA Class of II-IV.
Exclusion criteria
Health patients (must not have any of the following): 1. Cardiovascular disease 2. Receiving cardiovascular medication 3. Not in normal sinus rhythm (also required for HF patients)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To validate the diagnostic ability of the two devices against echo and clinical data as the gold standard. | Day 1 (study day) | We will construct received operative characteristic (Roc) curves for sensitivity and specificity of the HD Medical ViScope and the CSIRO back scatter analysis device in detecting heart failure using echocardiogram and clinical data as the gold standard. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation of the devices with standard tests such as BP, HR and BNP. | Day 1 (study day) | * Correlation of device values with echocardiogram parameters of systolic and diastolic function. * Correlation of device values with BNP levels. * Correlation of device values with heart rate variability measurements. * Correlation of device values with pulse wave velocity and systemic arterial compliance assessment measures. |
Countries
Australia
Outcome results
None listed