Optimized Glycemic Control in Heart Failure Patients With DM2:"Effect on Left Ventricular Function and Skeletal Muscle"

Phase 2

Completed

• Conditions: Type 2 Diabetes; Heart Failure
• Interventions: Other: all antidiabetic drugs will be appliable

• Registration Number: NCT01213784
• Lead Sponsor: University of Aarhus

Brief Summary

The investigators wish to investigate wether a more strict diabetic control improves cardiac function, muscle strength, exercise capacity and decreases symptoms.

The investigators hypothesis is that improving the glycemic control in suboptimized diabetics with heart failure will improve cardiac performance, muscle strength, exercise capacity and decrease symptoms.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2010-08-24
• Study Start: 2010-09
• Study First Submitted QC: 2010-10-01
• Study First Posted: 2010-10-04
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Status Verified: 2013-06
• Last Update Submitted: 2015-03-05
• Last Update Posted: 2015-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Ejection fraction =<45%
• Diabetes
• Hba1c =>7,5%
• In anticongestive treatment
• NYHA class 2-4

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Exclusion Criteria

• Severe angina (CCS 3-4)
• Hemodynamic significant heart valve disease
• Congenital heart disease
• Pregnancy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
optimized diabetic control	all antidiabetic drugs will be appliable	each participant will be assigned to be optimized in a dedicated diabetic clinic

Primary Outcome Measures

Name	Time	Method
Left ventricular function	4 month	Left ventricular function will be evaluated using echocardiografi measuring: - 2D Ejection fraction (using an ultrasound agent), global and regional tissue velocity, Strain / strain rate - all measures done during rest and dobutamin stress test.

Secondary Outcome Measures

Name	Time	Method
6-minutes hall walk test	4 month	using a hall walk protocol
Exercise capacity and peak oxygen consumption	4 month	using a treadmill test and continues oxygen consumption measurement
Muscle strength and mass	4 month	muscle strength: hand grip test
hormonal and metabolic profile	4 month	bloodsamples

Trial Locations

Locations (1)

Dept. of cardiology, Aarhus university hospital Skejby; 🇩🇰 Aarhus, Region Midtjylland, Denmark