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Intensive Glycemic Control for Congestive Heart Failure Exacerbation

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Kathleen Dungan, The Ohio State University
ClinicalTrials.gov Identifier:
NCT00812253
First received: December 19, 2008
Last updated: May 16, 2013
Last verified: May 2013
History of Changes
  Purpose

Patients with heart failure often have high blood sugar (glucose).


Condition Intervention Phase
Congestive Heart Failure
Diabetes Mellitus
 Drug: Intravenous insulin
Drug: Subcutaneous insulin
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intensive Glycemic Control for Congestive Heart Failure Exacerbation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • Hospital Length of Stay [ Time Frame: Days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hospital readmission [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Heart rate variability [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: 30 day ] [ Designated as safety issue: No ]
  • BNP [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
  • Cardiac Index [ Time Frame: 72 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 240
Study Start Date: January 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intravenous Insulin Drug: Intravenous insulin
Half of subjects will receive insulin through the intravenous route while the other half will receive 4 injections per day.
Active Comparator: Subcutaneous Insulin
Basal bolus insulin (4 injections per day)
 Drug: Subcutaneous insulin
Half of subjects will receive insulin through the intravenous route while the other half will receive 4 injections per day.

Detailed Description:

Patients with heart failure often have high blood sugar. High glucose contributes to severe hospital complications and even death. Studies suggest that heart failure patients who have high glucose or diabetes do not live as long as patients with normal glucose. In this study, we will determine whether normalizing blood sugars using intravenous insulin short-term will improve outcomes in patients hospitalized for congestive heart failure. We will enroll 240 patients with severe heart failure and divide them into 2 groups. We will use intravenous (given through the vein) insulin to lower blood sugar levels in group 1, and insulin injections in group 2. We will determine whether intravenous insulin improves hospital length of stay, rates of readmission, and other tests that predict mortality in patients with heart failure.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 and above
  • Admitted (less than 48 hours) to the OSU Ross Heart Hospital with worsening heart failure
  • Hyperglycemia or diabetes. Hyperglycemia is defined as blood glucose greater than 150 mg/dL on at least 2 occasions separated by at least 4 hours apart, insulin use, or HbA1c >6.5%.

Exclusion Criteria:

  • Type 1 diabetes
  • Receiving comfort care measures only
  • Hospital stay expected to be less than 2 days
  • Pregnancy
  • Prisoners
  • Participation in the study on prior hospitalizations
  • Acute myocardial infarction within 3 months
  • End stage renal or liver disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00812253

Locations
United States, Ohio
The Ohio State University
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Kathleen Dungan
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Kathleen M Dungan, MD Ohio State University
  More Information

No publications provided

Responsible Party: Kathleen Dungan, Assistant Professor, The Ohio State University
ClinicalTrials.gov Identifier: NCT00812253     History of Changes
Other Study ID Numbers: 2007H0197, 1K23DK080891-01A1
Study First Received: December 19, 2008
Last Updated: May 16, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Ohio State University:
Heart failure
Hyperglycemia
Hospital
Diabetes Mellitus

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

ClinicalTrials.gov processed this record on June 13, 2013