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OpenTrials
Completed

NCT Number: NCT01970319

Mechanisms and Reversibility of Heart Failure Associated With Diabetes

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Leeds General Infirmary

Leeds, LS1 3EX, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Type 2 diabetes

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Left ventricle mass

    Time frame: One year

Secondary outcomes

  1. Left ventricle function

    Time frame: 1 year

  2. RAAS activity

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Dr. Peter Swoboda

Other

Registry information

Acronym: MRHD

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Oct 28, 2013
Registry last updated
Sep 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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