Intensive Glycemic Control for Congestive Heart Failure Exacerbation

Kathleen Dungan

Status and phase: Completed; Phase 2

Conditions: Diabetes Mellitus; Congestive Heart Failure

Treatments: Drug: Intravenous insulin; Drug: Subcutaneous insulin

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00812253

2007H0197

1K23DK080891-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 74 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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74 participants in 2 patient groups

Intravenous Insulin

Experimental group

Treatment:

Drug: Intravenous insulin

Subcutaneous Insulin

Active Comparator group

Description:

Basal bolus insulin (4 injections per day)

Treatment:

Drug: Subcutaneous insulin