This trial is active, not recruiting.

Conditions congestive heart failure, diabetes mellitus
Treatments intravenous insulin, subcutaneous insulin
Phase phase 2
Sponsor Kathleen Dungan
Collaborator National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Start date January 2009
End date December 2013
Trial size 240 participants
Trial identifier NCT00812253, 1K23DK080891-01A1, 2007H0197


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
intravenous insulin
Half of subjects will receive insulin through the intravenous route while the other half will receive 4 injections per day.
(Active Comparator)
Basal bolus insulin (4 injections per day)
subcutaneous insulin
Half of subjects will receive insulin through the intravenous route while the other half will receive 4 injections per day.

Primary Outcomes

Hospital Length of Stay
time frame: Days

Secondary Outcomes

Hospital readmission
time frame: 30 days
Heart rate variability
time frame: 72 hours
Quality of Life
time frame: 30 day
time frame: 72 hours
Cardiac Index
time frame: 72 hours

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Intensive Glycemic Control for Congestive Heart Failure Exacerbation
Principal investigator Kathleen M Dungan, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2013.
Information provided to ClinicalTrials.gov by Ohio State University.