Diabetes Mellitus, Type 2NCT02862067
SGLT2 Inhibition in Diabetes and Heart Failure
An observational study of Diabetes Mellitus, Type 2 and Heart Failure, Systolic, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
To determine the effects of SGLT2 inhibition with empagliflozin on cardio-respiratory fitness in patients with systolic heart failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2, Heart Failure, Systolic
- What is being tested?
- Assessment of cardiorespiratory fitness
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to 16 Jan 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Patients with type 2 Diabetes Mellitus and Heart Failure with reduced Ejection Fraction or Systolic Heart Failure.
Who may be able to join
- Confirmed clinical diagnosis of stable HF (NYHA class II-III) on maximally tolerated HF medical regimen including angiotensin-inhibitors, beta-adrenergic blockers, and loop diuretics
- Reduced left ventricular systolic function (LVEF<50%) documented in the prior 12 months
- Poorly controlled T2DM (HbA1c levels between 6.5% and 10.0%)
- 18 years old and older.
Who cannot join
- Type I diabetes;
- Type II diabetes with episodes of severe hypoglycemia <50 mg/dl by history, frequent changes in anti-diabetic regimen class in the past 3 months or with a prior episode of diabetic ketoacidosis (any time);
- Open label treatment with SGLT2 inhibitors (within the past month);
- Treatment with thiazolidinedione (within the past month), which may induce volume and sodium retention;
- Chronic Kidney Disease (GFR<45 ml/kg*min);
- Uncontrolled thyroid dysfunction (TSH<0.4>4.5 mcIU/ml);
Show all 12Show fewer
- Pregnancy or of child-bearing potential;
- Active or recent (within 2 weeks) genital/urinal infection;
- Concomitant conditions or treatment which would affect completion or interpretation of the study including physical inability to walk or run on a treadmill such as decompensated HF (edema, NYHA class IV), significant ischemic heart disease, angina, arterial hypotension (BP systolic <90 mmHg), orthostatic arterial hypotension, arterial hypertension (resting BP systolic >160 mmHg), atrial fibrillation with rapid ventricular response, severe valvular disease, severe chronic obstructive or restrictive pulmonary disease, moderate- severe anemia (Hgb<10 g/dl);
- Abnormal BP or heart rate response, angina or ECG changes (ischemia or arrhy- thmias) occurring during baseline cardio-pulmonary exercise testing;
- Chronic use of oral corticosteroids;
- Inability to give informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
Official title: SGLT2 Inhibition in Diabetic Patients With Heart Failure With Reduced Ejection Fraction
To determine the effects of SGLT2 inhibition with empagliflozin on cardio-respiratory fitness in patients with systolic heart failure.
Read the detailed description
The investigators hypothesize that Sodium-GLucose coTransporters (SGLT)-2 inhibition will improve cardio-respiratory fitness (CRF) in patients with systolic heart failure.
Participants treated with SGLT2 inhibitor Empagliflozin as standard of care will undergo assessments described below.
The investigators will measure CRF with a validated cardiopulmonary exercise test at baseline and after 4 weeks of treatment received as standard of care, to determine whether SGLT2 inhibition improves cardio-respiratory fitness assessed by changes in peak oxygen consumption (VO2)(mL/kg/min) and minute ventilation (VE)/carbon dioxide production (VCO2) slope, powerful independent clinical predictors of mortality in HF.
- Conditions
- Diabetes Mellitus, Type 2, Heart Failure, Systolic
- Being tested
- Assessment of cardiorespiratory fitness
- Keywords
- SGLT2, type 2 diabetes mellitus, systolic heart failure, heart failure with reduced ejection fraction
- Medical subject headings
- Diabetes Mellitus, Type 2, Heart Failure, Systolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of cardiorespiratory fitnessOther
Assessment of cardiorespiratory fitness
What is being measured
The primary outcome is the main question the study is designed to answer.
SGLT2 inhibition effects on cardiorespiratory fitness (CRF).
To measure the effects of Empagliflozin on cardiorespiratory fitness in patients with type 2 diabetes and heart failure with reduced ejection fraction or systolic heart failure. The effects on CRF are determined by measuring changes in peak VO2 (mL/kg/min) and the VE/VCO2 slope.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2016 (estimated)
- Study startJul 2016
- Primary completion16 Jan 2018
- Study completion16 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Sponsor
- Investigators
- Salvatore Carbone, PhD, MS, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02862067
- Sponsor's protocol ID
- HM20007722
- Other IDs
- 16MCPRP31100003
- Status last verified
- Jul 2018
- First submitted
- 1 Aug 2016
- Last updated
- 16 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: The investigators plan to present the data promptly upon analysis as an abstract to a national meeting and/or a manuscript.
Publications
Carbone S, Canada JM, Billingsley HE, Kadariya D, Dixon DL, Trankle CR, Buckley LF, Markley R, Vo C, Medina de Chazal H, Christopher S, Buzzetti R, Van Tassell BW, Abbate A. Effects of empagliflozin on cardiorespiratory fitness and significant interaction of loop diuretics. Diabetes Obes Metab. 2018 Aug;20(8):2014-2018. doi: 10.1111/dom.13309. Epub 2018 Apr 23.
PubMed 29603546
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SGLT2 Inhibition in Diabetic Patients With Heart Failure With Reduced Ejection Fraction
- ClinicalTrials.gov ID
- NCT02862067
- Acronym / sponsor ID
- HM20007722
- Conditions
- Diabetes Mellitus, Type 2, Heart Failure, Systolic
- Keywords
- SGLT2, type 2 diabetes mellitus, systolic heart failure, heart failure with reduced ejection fraction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- Jul 2016
- Primary completion
- 16 Jan 2018 (actual)
- Study completion
- 16 Jan 2018 (actual)
- First posted
- 10 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the effects of SGLT2 inhibition with empagliflozin on cardio-respiratory fitness in patients with systolic heart failure.
Detailed description
The investigators hypothesize that Sodium-GLucose coTransporters (SGLT)-2 inhibition will improve cardio-respiratory fitness (CRF) in patients with systolic heart failure.
Participants treated with SGLT2 inhibitor Empagliflozin as standard of care will undergo assessments described below.
The investigators will measure CRF with a validated cardiopulmonary exercise test at baseline and after 4 weeks of treatment received as standard of care, to determine whether SGLT2 inhibition improves cardio-respiratory fitness assessed by changes in peak oxygen consumption (VO2)(mL/kg/min) and minute ventilation (VE)/carbon dioxide production (VCO2) slope, powerful independent clinical predictors of mortality in HF.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with type 2 Diabetes Mellitus and Heart Failure with reduced Ejection Fraction or Systolic Heart Failure.
Key inclusion criteria (4 listed)
- Confirmed clinical diagnosis of stable HF (NYHA class II-III) on maximally tolerated HF medical regimen including angiotensin-inhibitors, beta-adrenergic blockers, and loop diuretics
- Reduced left ventricular systolic function (LVEF<50%) documented in the prior 12 months
- Poorly controlled T2DM (HbA1c levels between 6.5% and 10.0%)
- 18 years old and older.
Key exclusion criteria (12 listed)
- Type I diabetes;
- Type II diabetes with episodes of severe hypoglycemia <50 mg/dl by history, frequent changes in anti-diabetic regimen class in the past 3 months or with a prior episode of diabetic ketoacidosis (any time);
- Open label treatment with SGLT2 inhibitors (within the past month);
- Treatment with thiazolidinedione (within the past month), which may induce volume and sodium retention;
- Chronic Kidney Disease (GFR<45 ml/kg*min);
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 |
|---|---|---|
| Assessment of cardiorespiratory fitnessAssessment of cardiorespiratory fitness | Other | – |
Primary outcome
SGLT2 inhibition effects on cardiorespiratory fitness (CRF).
Time frame: 4 weeks
To measure the effects of Empagliflozin on cardiorespiratory fitness in patients with type 2 diabetes and heart failure with reduced ejection fraction or systolic heart failure. The effects on CRF are determined by measuring changes in peak VO2 (mL/kg/min) and the VE/VCO2 slope.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2018.
- Results publication: PubMed 29603546Carbone S, Canada JM, Billingsley HE, Kadariya D, Dixon DL, Trankle CR, Buckley LF, Markley R, Vo C, Medina de Chazal H, Christopher S, Buzzetti R, Van Tassell BW, Abbate A. Effects of empagliflozin on cardiorespiratory fitness and significant interaction of loop diuretics. Diabetes Obes Metab. 2018 Aug;20(8):2014-2018. doi: 10.1111/dom.13309. Epub 2018 Apr 23.
- Individual participant dataSharing planned: No. The investigators plan to present the data promptly upon analysis as an abstract to a national meeting and/or a manuscript.
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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.
Salvatore Carbone, PhD, MS principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2 and Heart Failure, Systolic, run by Virginia Commonwealth University 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 4 inclusion and 12 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 16 Jul 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
SGLT2 inhibition effects on cardiorespiratory fitness (CRF). (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02862067, which also lists 1 linked publication.
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 16 Jul 2018.