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Intensive Glycemic Control for Congestive Heart Failure Exacerbation
This study has been completed.
Sponsor:
Kathleen Dungan
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Kathleen Dungan, The Ohio State University
ClinicalTrials.gov Identifier:
NCT00812253
First received: December 19, 2008
Last updated: July 14, 2014
Last verified: July 2014
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Purpose
Patients with heart failure often have high blood sugar (glucose).
| Condition | Intervention | Phase |
|---|---|---|
| Congestive Heart Failure Diabetes Mellitus | Drug: Intravenous insulin Drug: Subcutaneous insulin | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Intensive Glycemic Control for Congestive Heart Failure Exacerbation |
Resource links provided by NLM:
Further study details as provided by Kathleen Dungan, The Ohio State University:
Primary Outcome Measures:
- Hospital Length of Stay [ Time Frame: Days ]Duration of hospitalization in days
Secondary Outcome Measures:
- Hospital Readmission [ Time Frame: 30 days ]All-cause hospital readmission at 30 days after discharge
- Heart Rate Variability [ Time Frame: 72 hours ]
- Quality of Life [ Time Frame: 30 day ]
- Brain Natriuretic Peptide (BNP) [ Time Frame: 72 hours ]Brain natriuretic peptide (BNP) was measured at day 3
- Cardiac Index [ Time Frame: 72 hours ]
| Enrollment: | 74 |
| Study Start Date: | January 2009 |
| Study Completion Date: | May 2014 |
| Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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.
|
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.
Eligibility| 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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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00812253
Please refer to this study by its ClinicalTrials.gov identifier: NCT00812253
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
| 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 ) |
| Study First Received: | December 19, 2008 |
| Results First Received: | June 12, 2014 |
| Last Updated: | July 14, 2014 |
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 |
ClinicalTrials.gov processed this record on July 28, 2017