Optimized Glycemic Control in Heart Failure Patients With DM2:"Effect on Left Ventricular Function and Skeletal Muscle" (HFDM)
Primary Purpose
Type 2 Diabetes, Heart Failure
Status
Completed
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
all antidiabetic drugs will be appliable
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes
Eligibility 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
Sites / Locations
- Dept. of cardiology, Aarhus university hospital Skejby
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
optimized diabetic control
control
Arm Description
each participant will be assigned to be optimized in a dedicated diabetic clinic
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
hormonal and metabolic profile
bloodsamples
6-minutes hall walk test
using a hall walk protocol
Exercise capacity and peak oxygen consumption
using a treadmill test and continues oxygen consumption measurement
Muscle strength and mass
muscle strength: hand grip test
Full Information
NCT ID
NCT01213784
First Posted
August 24, 2010
Last Updated
March 5, 2015
Sponsor
University of Aarhus
Collaborators
The Danish Diabetes Association
1. Study Identification
Unique Protocol Identification Number
NCT01213784
Brief Title
Optimized Glycemic Control in Heart Failure Patients With DM2:"Effect on Left Ventricular Function and Skeletal Muscle"
Acronym
HFDM
Official Title
Optimized Glycemic Control in Type 2 Diabetics With Heart Failure:"Effect on Left Ventricular Function and Skeletal Muscle"
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
The Danish Diabetes Association
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
optimized diabetic control
Arm Type
Experimental
Arm Description
each participant will be assigned to be optimized in a dedicated diabetic clinic
Arm Title
control
Arm Type
No Intervention
Arm 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.
Intervention Type
Other
Intervention Name(s)
all antidiabetic drugs will be appliable
Intervention Description
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%
Primary Outcome Measure Information:
Title
Left ventricular function
Description
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.
Time Frame
4 month
Secondary Outcome Measure Information:
Title
hormonal and metabolic profile
Description
bloodsamples
Time Frame
4 month
Title
6-minutes hall walk test
Description
using a hall walk protocol
Time Frame
4 month
Title
Exercise capacity and peak oxygen consumption
Description
using a treadmill test and continues oxygen consumption measurement
Time Frame
4 month
Title
Muscle strength and mass
Description
muscle strength: hand grip test
Time Frame
4 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roni R Nielsen, MD
Organizational Affiliation
Dept. of cardiology, University hospital Aarhus Skejby
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. of cardiology, Aarhus university hospital Skejby
City
Aarhus
State/Province
Region Midtjylland
ZIP/Postal Code
8200
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
27158520
Citation
Nielsen R, Wiggers H, Thomsen HH, Bovin A, Refsgaard J, Abrahamsen J, Moller N, Botker HE, Norrelund H. Effect of tighter glycemic control on cardiac function, exercise capacity, and muscle strength in heart failure patients with type 2 diabetes: a randomized study. BMJ Open Diabetes Res Care. 2016 Apr 29;4(1):e000202. doi: 10.1136/bmjdrc-2016-000202. eCollection 2016.
Results Reference
derived
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Optimized Glycemic Control in Heart Failure Patients With DM2:"Effect on Left Ventricular Function and Skeletal Muscle"
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