Intensive Glycemic Control for Congestive Heart Failure Exacerbation

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

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus; Congestive Heart Failure
• Intervention / Treatment: Drug: Intravenous insulin; Drug: Subcutaneous insulin

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.

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intravenous Insulin	Drug: Intravenous insulin; Half of subjects will receive insulin through the intravenous route while the other half will receive 4 injections per day.
ACTIVE_COMPARATOR: Subcutaneous Insulin; Basal bolus insulin (4 injections per day)	Drug: Subcutaneous insulin; Half of subjects will receive insulin through the intravenous route while the other half will receive 4 injections per day.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Kathleen Dungan
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (ACTUAL): September 1, 2013
• Study Completion (ACTUAL): May 1, 2014

Study Registration Dates

• First Submitted: December 19, 2008
• First Submitted That Met QC Criteria: December 19, 2008
• First Posted (ESTIMATE): December 22, 2008

Study Record Updates

• Last Update Posted (ACTUAL): January 2, 2018
• Last Update Submitted That Met QC Criteria: December 3, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Diabetes Mellitus; Heart failure; Hospital; Hyperglycemia
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Heart Failure; Diabetes Mellitus; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc
• Other Study ID Numbers: 2007H0197; 1K23DK080891-01A1 (NIH)