Cardiovascular disease and clinical trials
Cardiovascular disease is the main cause of mortality in people with diabetes, and common risk factors, such as hypertension, obesity and dyslipidemia, show a high prevalence in patients with type 2 diabetes. The significance of controlling cardiovascular risk factors to reduce the risk for complications of CVD has been demonstrated numerous times, in particular for patients with type 2 diabetes.
In recent years, health authorities, including the FDA, have issued guidelines requiring drug developers to very carefully assess cardiovascular risks and to present reliable data on cardiovascular safety prior to obtaining marketing authorization for novel treatments for diabetes mellitus.
Including cardiovascular assessments in early phase studies may enable an assessment of potential cardiovascular risks in a timely manner. The combination of early and ongoing cardiometabolic and glucodynamic assessments may yield important insights into pleiotropic therapeutic mechanisms, for example by assessing the effects on micro- and macrovascular endothelial function or on variables altered by autonomic cardiac neuropathy.
Profil’s methodology for cardiovascular monitoring
Profil has many years of experience in using sophisticated, non-invasive cardiac and vascular methodology, including:
- High-resolution vascular ultrasound (e.g. flow-mediated dilatation, intima-media-thickness)
- Laser Doppler measurements
- Cardiovascular autonomic testing (Ewing battery of challenge maneuvers)
- Venous occlusion plethysmography
- Telemetric ECG monitoring
- 24-hour blood pressure monitoring
- ECG (compatible with FDA requirements)
Clinical trial subject recruitment
Thanks to Profil’s extensive, expertly curated patient database and cooperation with diabetologists and cardiologists, we can quickly recruit varied subject populations: with and without diabetes; with and without specific cardiovascular risk factors; and with various stages of cardiovascular disease.