Intensive Glycemic Control for Congestive Heart Failure Exacerbation

Kathleen Dungan74 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Congestive Heart Failure Diabetes Mellitus

Interventions

Intravenous insulinDRUG

Half of subjects will receive insulin through the intravenous route while the other half will receive 4 injections per day.

Subcutaneous insulinDRUG

Half of subjects will receive insulin through the intravenous route while the other half will receive 4 injections per day.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

The Ohio State University

Columbus, Ohio, United States

Outcomes

Primary Outcomes

Hospital Length of Stay

Duration of hospitalization in days

Time frame: Days

Secondary Outcomes

Hospital Readmission

All-cause hospital readmission at 30 days after discharge

Time frame: 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).

Time frame: 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),

Time frame: 30 day

Brain Natriuretic Peptide (BNP)

Brain natriuretic peptide (BNP) was measured at day 3

Time frame: 72 hours

Data from ClinicalTrials.gov

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