Intensive Glycemic Control for Congestive Heart Failure Exacerbation

NCT ID: NCT00812253

Last Updated: 2018-01-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2014-05-31

Brief Summary

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

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 enrolled patients with severe heart failure and randomly assigned them into 2 groups. We used intravenous (given through the vein) insulin to lower blood sugar levels in group 1, and insulin injections in group 2. We determined whether intravenous insulin improved hospital length of stay, rates of readmission, inflammatory markers, and cardiovascular tests that predict mortality in patients with heart failure.

Conditions

Congestive Heart Failure; Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intravenous Insulin

Group Type: EXPERIMENTAL

Intravenous insulin

Intervention Type: DRUG

Half of subjects will receive insulin through the intravenous route while the other half will receive 4 injections per day.

Subcutaneous Insulin

Basal bolus insulin (4 injections per day)

Group Type: ACTIVE_COMPARATOR

Subcutaneous insulin

Intervention Type: DRUG

Half of subjects will receive insulin through the intravenous route while the other half will receive 4 injections per day.

Interventions

Intravenous insulin

Half of subjects will receive insulin through the intravenous route while the other half will receive 4 injections per day.

Intervention Type: DRUG

Subcutaneous insulin

Half of subjects will receive insulin through the intravenous route while the other half will receive 4 injections per day.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Kathleen Dungan

OTHER

Sponsor Role: lead

Responsible Party

Kathleen Dungan

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Kathleen M Dungan, MD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

The Ohio State University

Columbus, Ohio, United States

Countries

United States

Other Identifiers

1K23DK080891-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2007H0197

Identifier Type: -

Identifier Source: org_study_id