NCT01422057

Risk Prediction in Type II Diabetics With Ischemic Heart Disease

Risk Prediction in Type II Diabetics With Ischemic Heart Disease by Cardiac Autonomic Function

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Thebiosignals.com · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to test whether cardiac autonomic dysfunction predicts is a prognostic marker in type-2 diabetics with ischemic heart disease

Detailed description

In patients with type 2-diabetes and ischemic heart disease autonomic function might be seriously affected. In the present study, markers of cardiac autonomic dysfunction, repolarization and respiration abnormalities will be assessed from Holter recordings and 30-minute recordings of high-resolution three dimensional ECG, non-invasive arterial blood pressure and respiratory activity. The correlation between markers of cardiac autonomic dysfunction and markers of severity of type-2 diabetes will be assessed. Autonomic dysfunction is assumed present when both heart rate turbulence and deceleration capacity are abnormal ("severe autonomic failure"). Assessment of severity of diabetes includes levels of HbA1c and urine albumine, duration and treatment of diabetes, and diabetes related complications (nephropathy, neuropathy, retinopathy).

Conditions

• Type-2 Diabetes Mellitus
• Ischemic Heart Disease

Timeline

• Start date: 2010-01-01
• Primary completion: 2014-01-01
• Completion: 2016-01-01
• First posted: 2011-08-23
• Last updated: 2014-02-06

Locations

1 site across 1 country: Germany