Intensive Glycemic Control for Congestive Heart Failure Exacerbation

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Congestive Heart Failure; Diabetes Mellitus	Drug: Intravenous insulin; Drug: Subcutaneous insulin	Phase 2

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	74 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Intensive Glycemic Control for Congestive Heart Failure Exacerbation
Study Start Date :	January 2009
Actual Primary Completion Date :	September 2013
Actual Study Completion Date :	May 2014

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Outcome Measures

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Primary Outcome Measures :

1. Hospital Length of Stay [ Time Frame: Days ]
   Duration of hospitalization in days

Secondary Outcome Measures :

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

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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

Sponsors and Collaborators

Kathleen Dungan

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

Principal Investigator:	Kathleen M Dungan, MD	Ohio State University

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Kathleen Dungan, Assistant Professor, The Ohio State University
ClinicalTrials.gov Identifier:	NCT00812253 History of Changes
Other Study ID Numbers:	2007H0197; 1K23DK080891-01A1 ( U.S. NIH Grant/Contract )
First Posted:	December 22, 2008
Results First Posted:	August 7, 2014
Last Update Posted:	January 2, 2018
Last Verified:	December 2017

Keywords provided by Kathleen Dungan, The Ohio State University:

Heart failure; Hyperglycemia; Hospital; Diabetes Mellitus

Additional relevant MeSH terms:

Diabetes Mellitus; Heart Failure; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Heart Diseases	Cardiovascular Diseases; Insulin, Globin Zinc; Insulin; Hypoglycemic Agents; Physiological Effects of Drugs