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OpenTrials
Completed

NCT Number: NCT01213784

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

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.

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Key information

Conditions

Type 2 Diabetes Cardiovascular Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Heart Diseases Heart Failure Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Dept. of cardiology, Aarhus university hospital Skejby

Aarhus, Central Jutland, 8200, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

all antidiabetic drugs will be appliable

Other

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 outcomes

  1. Left ventricular function

    Time frame: 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 outcomes

  1. hormonal and metabolic profile

    Time frame: 4 month

    bloodsamples

  2. 6-minutes hall walk test

    Time frame: 4 month

    using a hall walk protocol

  3. Exercise capacity and peak oxygen consumption

    Time frame: 4 month

    using a treadmill test and continues oxygen consumption measurement

  4. Muscle strength and mass

    Time frame: 4 month

    muscle strength: hand grip test

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • The Danish Diabetes Association

Registry information

Official study title

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

Acronym: HFDM

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Oct 4, 2010
Registry last updated
Mar 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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