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

University of Aarhus

Status and phase: Completed; Phase 2

Conditions: Heart Failure; Type 2 Diabetes

Treatments: Other: all antidiabetic drugs will be appliable

Study type: Interventional

Funder types: Other

Identifiers

NCT01213784

M20090047

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

optimized diabetic control

Experimental group

Description:

each participant will be assigned to be optimized in a dedicated diabetic clinic

Treatment:

Other: all antidiabetic drugs will be appliable

control

No Intervention group

Description:

participants will be assigned to follow what ever control they were in before the study and not to change any antidiabetic treatment during the interventions period.