Mechanisms and Reversibility of Heart Failure Associated With Diabetes
MRHD
1 other identifier
observational
110
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2013
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2013
CompletedFirst Submitted
Initial submission to the registry
October 22, 2013
CompletedFirst Posted
Study publicly available on registry
October 28, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedSeptember 21, 2016
September 1, 2016
1.7 years
October 22, 2013
September 20, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Left ventricle mass
One year
Secondary Outcomes (2)
Left ventricle function
1 year
RAAS activity
1 year
Study Arms (2)
Diabetic with nephropathy
Diabetics without nephropathy
Eligibility Criteria
Primary care patients with type 2 diabetes
You may qualify if:
- Type 2 diabetes
You may not qualify if:
- Known cardiac or renal disease
- Uncontrolled hypertension
- Treatment with ACEi/ARB
- Treatment with insulin
- Contraindication to CMR
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Leeds General Infirmary
Leeds, LS1 3EX, United Kingdom
Related Publications (2)
Swoboda PP, Erhayiem B, Kan R, McDiarmid AK, Garg P, Musa TA, Dobson LE, Witte KK, Kearney MT, Barth JH, Ajjan R, Greenwood JP, Plein S. Cardiovascular magnetic resonance measures of aortic stiffness in asymptomatic patients with type 2 diabetes: association with glycaemic control and clinical outcomes. Cardiovasc Diabetol. 2018 Mar 5;17(1):35. doi: 10.1186/s12933-018-0681-4.
PMID: 29506523DERIVEDSwoboda PP, McDiarmid AK, Erhayiem B, Ripley DP, Dobson LE, Garg P, Musa TA, Witte KK, Kearney MT, Barth JH, Ajjan R, Greenwood JP, Plein S. Diabetes Mellitus, Microalbuminuria, and Subclinical Cardiac Disease: Identification and Monitoring of Individuals at Risk of Heart Failure. J Am Heart Assoc. 2017 Jul 17;6(7):e005539. doi: 10.1161/JAHA.117.005539.
PMID: 28716801DERIVED
Biospecimen
Frozen serum
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- BHF Clinical Research Training Fellow
Study Record Dates
First Submitted
October 22, 2013
First Posted
October 28, 2013
Study Start
October 1, 2013
Primary Completion
June 1, 2015
Study Completion
January 1, 2016
Last Updated
September 21, 2016
Record last verified: 2016-09