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Intensive Glycemic Control for Congestive Heart Failure Exacerbation

Primary Purpose

Congestive Heart Failure, Diabetes Mellitus

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Intravenous insulin
Subcutaneous insulin
Sponsored by
Kathleen Dungan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congestive Heart Failure focused on measuring Heart failure, Hyperglycemia, Hospital, Diabetes Mellitus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Ohio State University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intravenous Insulin

Subcutaneous Insulin

Arm Description

Basal bolus insulin (4 injections per day)

Outcomes

Primary Outcome Measures

Hospital Length of Stay
Duration of hospitalization in days

Secondary Outcome Measures

Hospital Readmission
All-cause hospital readmission at 30 days after discharge
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).
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),
Brain Natriuretic Peptide (BNP)
Brain natriuretic peptide (BNP) was measured at day 3
Cardiac Output
Cardiac output measured using impedance cardiography at 72 hours.

Full Information

First Posted
December 19, 2008
Last Updated
December 3, 2017
Sponsor
Kathleen Dungan
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT00812253
Brief Title
Intensive Glycemic Control for Congestive Heart Failure Exacerbation
Official Title
Intensive Glycemic Control for Congestive Heart Failure Exacerbation
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kathleen Dungan
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure, Diabetes Mellitus
Keywords
Heart failure, Hyperglycemia, Hospital, Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intravenous Insulin
Arm Type
Experimental
Arm Title
Subcutaneous Insulin
Arm Type
Active Comparator
Arm Description
Basal bolus insulin (4 injections per day)
Intervention Type
Drug
Intervention Name(s)
Intravenous insulin
Intervention Description
Half of subjects will receive insulin through the intravenous route while the other half will receive 4 injections per day.
Intervention Type
Drug
Intervention Name(s)
Subcutaneous insulin
Intervention Description
Half of subjects will receive insulin through the intravenous route while the other half will receive 4 injections per day.
Primary Outcome Measure Information:
Title
Hospital Length of Stay
Description
Duration of hospitalization in days
Time Frame
Days
Secondary Outcome Measure Information:
Title
Hospital Readmission
Description
All-cause hospital readmission at 30 days after discharge
Time Frame
30 days
Title
Heart Rate Variability
Description
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
Title
Change in Quality of Life
Description
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
Title
Brain Natriuretic Peptide (BNP)
Description
Brain natriuretic peptide (BNP) was measured at day 3
Time Frame
72 hours
Title
Cardiac Output
Description
Cardiac output measured using impedance cardiography at 72 hours.
Time Frame
72 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathleen M Dungan, MD
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

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Intensive Glycemic Control for Congestive Heart Failure Exacerbation

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