Assessment of Myocardial Disease in Man Using Novel Non-invasive Diagnostic Tools

Prof Henry Krum

Status and phase: Terminated; Phase 1

Conditions: Cardiovascular Diseases

Treatments: Device: HD medical device (ViScope); Device: CSIRO device

Study type: Interventional

Funder types: Other

Identifiers

NCT00507312

CP-03/06

Details and patient eligibility

About

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.

Enrollment: 41 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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41 participants in 3 patient groups

1

Active Comparator group

Description:

Healthy subjects (with no evidence of cardiovascular disease).

Treatment:

Device: HD medical device (ViScope)

Device: CSIRO device

2

Experimental group

Description:

Patients with risk factors for heart failure

Treatment:

Device: HD medical device (ViScope)

Device: CSIRO device

3

Experimental group

Description:

Patients with heart failure

Treatment:

Device: HD medical device (ViScope)

Device: CSIRO device