Congestive Heart FailurePhase 1/2NCT00812487
Glycemic Control and Variability for Congestive Heart Failure Exacerbation
A Phase 1/2 study testing Intravenous insulin and Subcutaneous insulin in people with Congestive Heart Failure and Diabetes Mellitus, run by Kathleen Dungan at 1 site in United States.
Trial summary
High glucose as well as fluctuations (rapid swings) in blood glucose can contribute to severe hospital complications and even death. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congestive Heart Failure, Diabetes Mellitus
- What is being tested?
- Intravenous insulin and Subcutaneous insulin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Sep 2013
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 and above
- Admitted (less than 48 hours) to the 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%.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
High glucose as well as fluctuations (rapid swings) in blood glucose can contribute to severe hospital complications and even death.
Read the detailed description
High glucose as well as fluctuations in blood glucose can contribute to severe hospital complications and even death. Studies also suggest that heart failure patients who have high glucose or diabetes do not live as long as patients with normal glucose. Glucose fluctuations have not been well-studied in patients with heart failure. In this study, we will determine whether better control of blood sugar fluctuations in the hospital improve outcomes. We will enroll 80 patients with severe heart failure and divide them into 2 groups. We will use intravenous (given through the vein) insulin to lower blood sugar levels in group 1, and insulin injections (under the skin) in group 2. We will determine whether intravenous insulin improves blood markers of inflammation, changes in vital signs, and other tests that predict mortality in patients with heart failure.
- Conditions
- Congestive Heart Failure, Diabetes Mellitus
- Being tested
- Intravenous insulin, Subcutaneous insulin
- Keywords
- congestive heart failure, diabetes mellitus, hyperglycemia
- Medical subject headings
- Heart Failure, Diabetes Mellitus, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous insulinDrug
Patients will receive continuous insulin infusion through the vein.
Subcutaneous insulinDrug
4 injections of insulin/day
| Study group | Role | What they receive |
|---|---|---|
| Intravenous insulin | Experimental | Not described Receives: Drug: Intravenous insulin |
| Subcutaneous Insulin | Active comparator | 4 injections of insulin/day Receives: Drug: Subcutaneous insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Length of Stay
Duration of hospitalization
Measured: participants were followed for the duration of hospital stay, median hospital stay 8 day
Hospital Readmission
All-cause hospital readmission within 30 days
Measured: 30 days
Secondary outcomes (8)
High Frequency Heart Rate Variability
High frequency heart rate variability (HF HRV)is a measure of cardiac autonomic tone. Electrocardiographic measures were obtained using a Bionex system (Mindware, Gahanna, OH). The electrocardiogram was performed in the standard lead II configuration. Software (Mindware, Gahanna, OH) was used to derive HF HRV. HF HRV was calculated using power spectral analysis.
Measured: 24 hours
Pre-ejection Period (PEP)
Pre-ejection period (PEP) is the time between the onset of electrical depolarization of the ventricle and the opening of the aortic valve, a measure of sympathetic tone. It is obtained noninvasively using cardiac impedance obtained using a Bionex system (Mindware, Gahanna, OH). PEP is measured in milliseconds; lower values reflect higher sympathetic tone.
Measured: 24 hours
High Sensitivity C-reactive Protein (Hs-CRP)
High sensitivity C-reactive Protein (hs-CRP) is a measure of inflammation. hsCRP (range 0-15 mg/L) was performed using Immunlite 1000 assay (Siemens; Erlangen, Germany).
Measured: 72 hours
Brain Natriuretic Peptide (BNP)
Laboratory analyses were performed by the study institution's Clinical Research Center using standard commercial kits
Measured: 72 hours
Quality of Life
Quality of Life was measured using the Minnesota Living with Heart Failure Questionnaire, which is a 21 question survey that uses a likert scale of 0-5. Each item asks over the past 4 weeks whether they have had a particular symptom of heart failure and to classify the response as no symptoms (0) to having the symptom very much (5). Responses are summed for a total score (0-105).
Measured: 30 days
Glycemic Lability Index (GLI)
GLI is a measure of glycemic variability. GLI is the sum of the square of the difference between successive glucose measurements divided by the difference in time between measurements
Measured: 24 hours
Coefficient of Variation (CV)
CV is a measure of glycemic variability
Measured: 24 hours
Mean Glucose
mean sensor glucose
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2008 (estimated)
- Study startJan 2009
- Primary completionAug 2012
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Congestive Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kathleen Dungan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kathleen Dungan, Ohio State University
- Investigators
- Kathleen M Dungan, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00812487
- Sponsor's protocol ID
- 2008H0087
- Other IDs
- 1R21DK081877-01
- Status last verified
- Nov 2013
- First submitted
- 19 Dec 2008
- Last updated
- 31 Dec 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glycemic Control and Variability for Congestive Heart Failure Exacerbation
- ClinicalTrials.gov ID
- NCT00812487
- Acronym / sponsor ID
- 2008H0087
- Conditions
- Congestive Heart Failure, Diabetes Mellitus
- Keywords
- congestive heart failure, diabetes mellitus, hyperglycemia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Kathleen DunganUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Jan 2009
- Primary completion
- Aug 2012 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 22 Dec 2008 (estimated)
- Results
- Posted 31 Dec 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
High glucose as well as fluctuations (rapid swings) in blood glucose can contribute to severe hospital complications and even death.
Detailed description
High glucose as well as fluctuations in blood glucose can contribute to severe hospital complications and even death. Studies also suggest that heart failure patients who have high glucose or diabetes do not live as long as patients with normal glucose. Glucose fluctuations have not been well-studied in patients with heart failure. In this study, we will determine whether better control of blood sugar fluctuations in the hospital improve outcomes. We will enroll 80 patients with severe heart failure and divide them into 2 groups. We will use intravenous (given through the vein) insulin to lower blood sugar levels in group 1, and insulin injections (under the skin) in group 2. We will determine whether intravenous insulin improves blood markers of inflammation, changes in vital signs, and other tests that predict mortality in patients with heart failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravenous insulin | Experimental | Drug: Intravenous insulin |
| Subcutaneous Insulin | Active comparator | Drug: Subcutaneous insulin4 injections of insulin/day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 and above
- Admitted (less than 48 hours) to the 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%.
Key exclusion criteria (8 listed)
- Type 1 diabetes
- Receiving comfort care measures only
- Hospital stay expected to be less than 2 days
- Pregnancy
- Prisoners
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravenous insulinPatients will receive continuous insulin infusion through the vein. | Drug | Intravenous insulin |
| Subcutaneous insulin4 injections of insulin/day | Drug | Subcutaneous Insulin |
Primary outcome
Hospital Length of Stay
Time frame: participants were followed for the duration of hospital stay, median hospital stay 8 day
Duration of hospitalization
Hospital Readmission
Time frame: 30 days
All-cause hospital readmission within 30 days
8 secondary outcomes
High Frequency Heart Rate Variability
Time frame: 24 hours
Pre-ejection Period (PEP)
Time frame: 24 hours
High Sensitivity C-reactive Protein (Hs-CRP)
Time frame: 72 hours
Brain Natriuretic Peptide (BNP)
Time frame: 72 hours
Quality of Life
Time frame: 30 days
Glycemic Lability Index (GLI)
Time frame: 24 hours
Coefficient of Variation (CV)
Time frame: 24 hours
Mean Glucose
Time frame: 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Congestive Heart Failure
RecruitingPhase 2/3
Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)
Heart Failure, Left Ventricular Systolic Dysfunction
RecruitingPhase 1/2
HS235 Study in Overweight and Obese Participants With Combined Pre and Post-Capillary Pulmonary Hypertension Due to Heart Failure With Preserved Ejection Fraction
Pulmonary Hypertension, Heart Failure With Preserved Ejection Fraction
Active, not recruiting
Heart Failure Patient Management and Interventions Using Continuous Patient Monitoring Outside Hospitals and Real-world Data
Chronic Heart Failure, Heart Transplant Recipient
Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
Not yet recruitingObservational study
Real-world Effectiveness and Safety of Savagen (Sacubitril/Valsartan) in Malaysian HFrEF Patients
Heart Failure With Reduced Ejection Fraction (HFrEF), Heart Failure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathleen M Dungan, MD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Intravenous insulin and Subcutaneous insulin in people with Congestive Heart Failure and Diabetes Mellitus, run by Kathleen Dungan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Dec 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital Length of Stay (time frame: participants were followed for the duration of hospital stay, median hospital stay 8 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2013.