Intensive Glycemic Control for Congestive Heart Failure Exacerbation

Phase 2

Completed

Conditions: Congestive Heart Failure
Diabetes Mellitus

Interventions: Drug: Subcutaneous insulin
Drug: Intravenous insulin

Registration Number: NCT00812253

Lead Sponsor: Kathleen Dungan

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 74

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Subcutaneous Insulin	Subcutaneous insulin	Basal bolus insulin (4 injections per day)
Intravenous Insulin	Intravenous insulin	-

Primary Outcome Measures

Name	Time	Method
Hospital Length of Stay	Days	Duration of hospitalization in days

Secondary Outcome Measures

Name	Time	Method
Hospital Readmission	30 days	All-cause hospital readmission at 30 days after discharge
Heart Rate Variability	72 hours	High frequency (HF) Heart rate variability (HRV). HRV was assessed with a Bionex system (Mindware, Gahanna, OH). The electrocardiogram was performed in the standard lead II configuration and impedance cardiography was performed using a standard tetrapolar arrangement. Measures were performed at baseline and each morning (0800-1000 hour) during and following the intervention for 7 minutes each. Software (Mindware, Gahanna, OH) was used to derive HF HRV. The middle five minutes of the recordings were scored minute by minute and the first suitable1 minute period was used for calculation. Five minute epochs were not feasible due to an unexpectedly high frequency of ectopy. One minute intervals allow calculation of HF (parasympathetic tone) but not low frequency (combination of sympathetic and parasympathetic tone).
Change in Quality of Life	30 day	Change in Quality of Life questionnaire measured from baseline (enrollment) to 30 days following discharge. The questionnaire is a self-administered disease-specific questionnaire for patients with HF, comprising 21 items rated on six-point Likert scales, representing different degrees of impact of HF on health related quality of life, from 0 (none) to 5 (very much). It provides a total score (range 0-105, from best to worst HRQoL),
Cardiac Output	72 hours	Cardiac output measured using impedance cardiography at 72 hours.
Brain Natriuretic Peptide (BNP)	72 hours	Brain natriuretic peptide (BNP) was measured at day 3