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

This study is currently recruiting participants.
Verified March 2012 by University of Aarhus
Sponsor:
Collaborator:
The Danish Diabetes Association
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01213784
First received: August 24, 2010
Last updated: March 20, 2012
Last verified: March 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes
Heart Failure
 Other: all antidiabetic drugs will be appliable
Other: no intervention
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Optimized Glycemic Control in Type 2 Diabetics With Heart Failure:"Effect on Left Ventricular Function and Skeletal Muscle"

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Left ventricular function [ Time Frame: 4 month ] [ Designated as safety issue: No ]

    Left ventricular function will be evaluated using echocardiografi measuring:

    • 2D and 3D Ejection fraction (using an ultrasound agent), global and regional tissue velocity, Strain / strain rate - all measures done during rest and dobutamin stress test.
    • diastolic parameters

  • Muscle strength and mass [ Time Frame: 4 month ] [ Designated as safety issue: No ]
    muscle strength: hand grip test Muscle mass: DXA scan


Secondary Outcome Measures:
  • hormonal and metabolic profile [ Time Frame: 4 month ] [ Designated as safety issue: No ]
    bloodsamples

  • 6-minutes hall walk test [ Time Frame: 4 month ] [ Designated as safety issue: No ]
    using a hall walk protocol

  • Exercise capacity and peak oxygen consumption [ Time Frame: 4 month ] [ Designated as safety issue: No ]
    using a treadmill test and continues oxygen consumption measurement


Estimated Enrollment: 40
Study Start Date: March 2010
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: optimized diabetic control
each participant will be assigned to be optimized in a dedicated diabetic clinic
 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%
No Intervention: control
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.
 Other: no intervention
no optimization will be done

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01213784

Contacts
Contact: Roni R Nielsen, MD +45 5121 9363 roni.r.nielsen@gmail.com

Locations
Denmark
Dept. of cardiology, Aarhus university hospital Skejby Recruiting
Aarhus, Region Midtjylland, Denmark, 8200
Contact: Roni R Nielsen, MD     +45 5121 9363     roni.r.nielsen@gmail.com    
Principal Investigator: Roni R Nielsen, MD            
Sponsors and Collaborators
University of Aarhus
The Danish Diabetes Association
Investigators
Principal Investigator: Roni R Nielsen, MD Dept. of cardiology, University hospital Aarhus Skejby
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01213784     History of Changes
Other Study ID Numbers: M20090047
Study First Received: August 24, 2010
Last Updated: March 20, 2012
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Heart Failure
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Heart Diseases
Cardiovascular Diseases
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013