Intensive Glycemic Control for Congestive Heart Failure Exacerbation

Diabetes Mellitus Clinical Trial

Official title:

Intensive Glycemic Control for Congestive Heart Failure Exacerbation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00812253
• Other study ID #: 2007H0197
• Secondary ID: 1K23DK080891-01A
• Status: Completed
• Phase: Phase 2
• First received: December 19, 2008
• Last updated: December 3, 2017
• Start date: January 2009
• Est. completion date: May 2014

Study information

• Verified date: December 2017
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: May 2014
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Congestive Heart Failure
• Diabetes Mellitus
• Heart Failure

Intervention

Drug:
• Intravenous insulin
Half of subjects will receive insulin through the intravenous route while the other half will receive 4 injections per day.
• Subcutaneous insulin
Half of subjects will receive insulin through the intravenous route while the other half will receive 4 injections per day.

Locations

Country	Name	City	State
United States	The Ohio State University	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Kathleen Dungan	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital Length of Stay	Duration of hospitalization in days	Days
Secondary	Hospital Readmission	All-cause hospital readmission at 30 days after discharge	30 days
Secondary	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
Secondary	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
Secondary	Brain Natriuretic Peptide (BNP)	Brain natriuretic peptide (BNP) was measured at day 3	72 hours
Secondary	Cardiac Output	Cardiac output measured using impedance cardiography at 72 hours.	72 hours