Mechanisms and Reversibility of Heart Failure Associated With Diabetes

Completed

• Conditions: Type 2 Diabetes

• Registration Number: NCT01970319
• Lead Sponsor: Dr. Peter Swoboda

Brief Summary

Patients with diabetes have a higher incidence of heart failure and worse outcomes than normoglycaemic subjects. Basic science research has suggested many mechanisms for this observation including endothelial dysfunction, abnormal calcium handling, fibrosis and activation of the renin-angiotensin-aldosterone system (RAAS), but clinical data are lacking. In this study the investigators will investigate the relationship between diabetes and heart failure by exploring the correlation between microvascular dysfunction and cardiac magnetic resonance (CMR) markers of left ventricular (LV) hypertrophy, cardiac dysfunction and fibrosis. The investigators also propose to see if this relationship is independent of blood pressure and markers of RAAS activity. This could have important clinical ramifications in type 2 diabetes by increasing the indications for treatment with RAAS inhibition or making a case for lower blood pressure targets.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-10-22
• Study First Submitted QC: 2013-10-25
• Study First Posted: 2013-10-28
• Primary Completion: 2015-06
• Study Completion: 2016-01
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-20
• Last Update Posted: 2016-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

• Type 2 diabetes

Exclusion Criteria

• Known cardiac or renal disease
• Uncontrolled hypertension
• Treatment with ACEi/ARB
• Treatment with insulin
• Contraindication to CMR

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Left ventricle mass	One year

Secondary Outcome Measures

Name	Time	Method
Left ventricle function	1 year
RAAS activity	1 year

Trial Locations

Locations (1)

Leeds General Infirmary; 🇬🇧 Leeds, United Kingdom