Glycemic Control and Variability for Congestive Heart Failure Exacerbation

Phase 1

Completed

Conditions: Congestive Heart Failure
Diabetes Mellitus

Interventions: Drug: Subcutaneous insulin
Drug: Intravenous insulin

Registration Number: NCT00812487

Lead Sponsor: Kathleen Dungan

Brief Summary: High glucose as well as fluctuations (rapid swings) in blood glucose can contribute to severe hospital complications and even death.

Detailed Description: High glucose as well as fluctuations in blood glucose can contribute to severe hospital complications and even death. Studies also suggest that heart failure patients who have high glucose or diabetes do not live as long as patients with normal glucose. Glucose fluctuations have not been well-studied in patients with heart failure. In this study, we will determine whether better control of blood sugar fluctuations in the hospital improve outcomes. We will enroll 80 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 (under the skin) in group 2. We will determine whether intravenous insulin improves blood markers of inflammation, changes in vital signs, and other tests that predict mortality in patients with heart failure.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 75

Inclusion Criteria

Age 18 and above
Admitted (less than 48 hours) to the 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	4 injections of insulin/day
Intravenous insulin	Intravenous insulin	-

Primary Outcome Measures

Name	Time	Method
Hospital Readmission	30 days	All-cause hospital readmission within 30 days
Hospital Length of Stay	participants were followed for the duration of hospital stay, median hospital stay 8 day	Duration of hospitalization

Secondary Outcome Measures

Name	Time	Method
High Frequency Heart Rate Variability	24 hours	High frequency heart rate variability (HF HRV)is a measure of cardiac autonomic tone. Electrocardiographic measures were obtained using a Bionex system (Mindware, Gahanna, OH). The electrocardiogram was performed in the standard lead II configuration. Software (Mindware, Gahanna, OH) was used to derive HF HRV. HF HRV was calculated using power spectral analysis.
Pre-ejection Period (PEP)	24 hours	Pre-ejection period (PEP) is the time between the onset of electrical depolarization of the ventricle and the opening of the aortic valve, a measure of sympathetic tone. It is obtained noninvasively using cardiac impedance obtained using a Bionex system (Mindware, Gahanna, OH). PEP is measured in milliseconds; lower values reflect higher sympathetic tone.
Coefficient of Variation (CV)	24 hours	CV is a measure of glycemic variability
High Sensitivity C-reactive Protein (Hs-CRP)	72 hours	High sensitivity C-reactive Protein (hs-CRP) is a measure of inflammation. hsCRP (range 0-15 mg/L) was performed using Immunlite 1000 assay (Siemens; Erlangen, Germany).
Quality of Life	30 days	Quality of Life was measured using the Minnesota Living with Heart Failure Questionnaire, which is a 21 question survey that uses a likert scale of 0-5. Each item asks over the past 4 weeks whether they have had a particular symptom of heart failure and to classify the response as no symptoms (0) to having the symptom very much (5). Responses are summed for a total score (0-105).
Mean Glucose	24 hours	mean sensor glucose
Brain Natriuretic Peptide (BNP)	72 hours	Laboratory analyses were performed by the study institution's Clinical Research Center using standard commercial kits
Glycemic Lability Index (GLI)	24 hours	GLI is a measure of glycemic variability. GLI is the sum of the square of the difference between successive glucose measurements divided by the difference in time between measurements