Intensive Glycemic Control for Congestive Heart Failure Exacerbation

Study Overview
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Brief Summary
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Patients with heart failure often have high blood sugar (glucose).

Detailed Description
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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.

Official Title
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Intensive Glycemic Control for Congestive Heart Failure Exacerbation

Conditions
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Congestive Heart Failure, Diabetes Mellitus

Intervention / Treatment
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* Drug: Intravenous insulin
* Drug: Subcutaneous insulin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intravenous Insulin<br> | Drug: Intravenous insulin<br>* Half of subjects will receive insulin through the intravenous route while the other half will receive 4 injections per day.<br>|
| Active Comparator: Subcutaneous Insulin<br>Basal bolus insulin (4 injections per day) | Drug: Subcutaneous insulin<br>* Half of subjects will receive insulin through the intravenous route while the other half will receive 4 injections per day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital Length of Stay | Duration of hospitalization in days | Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital Readmission | All-cause hospital readmission at 30 days after discharge | 30 days | 
| Heart Rate Variability | 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). | 72 hours | 
| Change in Quality of Life | 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), | 30 day | 
| Brain Natriuretic Peptide (BNP) | Brain natriuretic peptide (BNP) was measured at day 3 | 72 hours | 
| Cardiac Output | Cardiac output measured using impedance cardiography at 72 hours. | 72 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart failure, Hyperglycemia, Hospital, Diabetes Mellitus