Mechanisms and Reversibility of Heart Failure Associated With Diabetes

NCT ID: NCT01970319

Last Updated: 2016-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

110 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-10-31

Study Completion Date

2016-01-31

Brief Summary

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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

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Conditions

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Type 2 Diabetes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Diabetic with nephropathy

No interventions assigned to this group

Diabetics without nephropathy

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Type 2 diabetes

Exclusion Criteria

* Known cardiac or renal disease
* Uncontrolled hypertension
* Treatment with ACEi/ARB
* Treatment with insulin
* Contraindication to CMR
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dr. Peter Swoboda

OTHER

Sponsor Role lead

Responsible Party

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Dr. Peter Swoboda

BHF Clinical Research Training Fellow

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Leeds General Infirmary

Leeds, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 29506523 (View on PubMed)

Swoboda 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.

Reference Type DERIVED
PMID: 28716801 (View on PubMed)

Other Identifiers

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14606

Identifier Type: -

Identifier Source: org_study_id

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