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

Heart Failure Clinical Trial

— HFDM  

Official title:

Optimized Glycemic Control in Type 2 Diabetics With Heart Failure:"Effect on Left Ventricular Function and Skeletal Muscle"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01213784
• Other study ID #: M20090047
• Status: Completed
• Phase: Phase 2
• First received: August 24, 2010
• Last updated: March 5, 2015
• Start date: September 2010
• Est. completion date: November 2012

Study information

• Verified date: June 2013
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure
• Type 2 Diabetes

Intervention

Other:
• all antidiabetic drugs will be appliable
We expect all participants to be set on insulin during the intervention, however all types of insulin and other antidiabetics can be used goal: Hba1c lower than 7,5%

Locations

Country	Name	City	State
Denmark	Dept. of cardiology, Aarhus university hospital Skejby	Aarhus	Region Midtjylland

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	The Danish Diabetes Association

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Left ventricular function	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.	4 month	No
Secondary	hormonal and metabolic profile	bloodsamples	4 month	No
Secondary	6-minutes hall walk test	using a hall walk protocol	4 month	No
Secondary	Exercise capacity and peak oxygen consumption	using a treadmill test and continues oxygen consumption measurement	4 month	No
Secondary	Muscle strength and mass	muscle strength: hand grip test	4 month	No