Congestive Heart FailurePhase 2NCT00812253
Intensive Glycemic Control for Congestive Heart Failure Exacerbation
A Phase 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
Patients with heart failure often have high blood sugar (glucose). 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
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to May 2014
- Phase
- Phase 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 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%.
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
Patients with heart failure often have high blood sugar (glucose).
Read the 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.
- Conditions
- Congestive Heart Failure, Diabetes Mellitus
- Being tested
- Intravenous insulin, Subcutaneous insulin
- Keywords
- Heart failure, Hyperglycemia, Hospital, Diabetes Mellitus
- 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
Half of subjects will receive insulin through the intravenous route while the other half will receive 4 injections per day.
Subcutaneous insulinDrug
Half of subjects will receive insulin through the intravenous route while the other half will receive 4 injections per day.
| Study group | Role | What they receive |
|---|---|---|
| Intravenous Insulin | Experimental | Not described Receives: Drug: Intravenous insulin |
| Subcutaneous Insulin | Active comparator | Basal bolus insulin (4 injections per 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 in days
Measured: Days
Secondary outcomes (5)
Hospital Readmission
All-cause hospital readmission at 30 days after discharge
Measured: 30 days
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).
Measured: 72 hours
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),
Measured: 30 day
Brain Natriuretic Peptide (BNP)
Brain natriuretic peptide (BNP) was measured at day 3
Measured: 72 hours
Cardiac Output
Cardiac output measured using impedance cardiography at 72 hours.
Measured: 72 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 completionSep 2013
- Study completionMay 2014
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 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
- NCT00812253
- Sponsor's protocol ID
- 2007H0197
- Other IDs
- 1K23DK080891-01A1
- Status last verified
- Dec 2017
- First submitted
- 19 Dec 2008
- Last updated
- 2 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Glycemic Control for Congestive Heart Failure Exacerbation
- ClinicalTrials.gov ID
- NCT00812253
- Acronym / sponsor ID
- 2007H0197
- Conditions
- Congestive Heart Failure, Diabetes Mellitus
- Keywords
- Heart failure, Hyperglycemia, Hospital, Diabetes Mellitus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 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
- Sep 2013 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 22 Dec 2008 (estimated)
- Results
- Posted 7 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 insulinBasal bolus insulin (4 injections per 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 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%.
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 insulinHalf of subjects will receive insulin through the intravenous route while the other half will receive 4 injections per day. | Drug | Intravenous Insulin |
| Subcutaneous insulinHalf of subjects will receive insulin through the intravenous route while the other half will receive 4 injections per day. | Drug | Subcutaneous Insulin |
Primary outcome
Hospital Length of Stay
Time frame: Days
Duration of hospitalization in days
5 secondary outcomes
Hospital Readmission
Time frame: 30 days
Heart Rate Variability
Time frame: 72 hours
Change in Quality of Life
Time frame: 30 day
Brain Natriuretic Peptide (BNP)
Time frame: 72 hours
Cardiac Output
Time frame: 72 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Congestive Heart Failure
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Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)
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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
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Heart Failure Patient Management and Interventions Using Continuous Patient Monitoring Outside Hospitals and Real-world Data
Chronic Heart Failure, Heart Transplant Recipient
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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 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 2 Jan 2018. 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 phase mean?
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 7 Aug 2014). 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: Days). 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 2 Jan 2018.