Diabetes MellitusPhase 4NCT03977116
Sodium-glucose Co-transporter 2 Inhibitors Effects in Failing Heart Patients
A Phase 4 study testing SLGT2 in people with Diabetes Mellitus and Heart Failure, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
Trial summary
SLGT2 therapy is safety used in heart failure (HF) patients with depressed left ventricle ejection fraction (LVEF) and diabetes mellitus (DM). These patients experience higher rate of ventricular arrhythmias (VA), that are a leading cause of cardiac arrest and mortality. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Heart Failure, Ventricular Arrythmia
- What is being tested?
- SLGT2
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2017to 1 Mar 2019
- Phase
- Phase 4
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- heart failure (HF) under optimal maximal drug therapy with NYHA functional II-III;
- HF with prior echocardiographic evidence of left ventricular systolic dysfunction (LVEF <35 % or subjective assessment of LV dysfunction that is mild or worse);
- patients under furosemide 80 mg daily or less, or equivalent loop diuretic;
- patients with stable HF symptoms for at least 3 months prior to consent;
- patients on stable therapy for HF for at least 3 months prior to consent;
- patients without hospitalization for HF for at least 3 months prior to consent;
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- Ischemic and non ischemic dilated cardiomiopathy diagnosis;
- patients with internal cardioverter defibrillator (ICD);
- patients with cardioverter resynchronization therapy and defibrillator (CRTd);
- patients with diagnosis of diabetes mellitus (DM);
- patients aged >18 years and <75 years
Who cannot join
- Patients without ICD;
- patients without previous event of ventricular arrhythmia (VA);
- patients without indication to receive catheter ablation (CA) for VA;
- patients with type 1 diabetes mellitus;
- severe hepatic disease, renal disease defined as chronic kidney disease stage 3b or worse (i.e. glomerular filtration rate <45 ml/min);
- systolic blood pressure <95 mmHg at screening visit;
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- screening HbA1c <6.0 %;
- patients unable to walk or to perform cardio pulmonary exercise testing or six minute walking test;
- malignancy (receiving active treatment) or other life threatening diseases;
- pregnant or lactating women;
- patients who have participated in any other clinical trial of an investigational medicinal product within the previous 30 days;
- patients who were unable to give informed consent;
- any other reason considered by a study physician to be inappropriate for inclusion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Outcomes and Long Term Effects of Sodium-glucose Co-transporter 2 Inhibitors in Diabetes Mellitus and Failing Heart Patients With Implantable Cardioverter Defibrillator Undergoing Trans-catheter Ablation for Ventricular Arrhythmias.
SLGT2 therapy is safety used in heart failure (HF) patients with depressed left ventricle ejection fraction (LVEF) and diabetes mellitus (DM). These patients experience higher rate of ventricular arrhythmias (VA), that are a leading cause of cardiac arrest and mortality. However, these patients are treated by implantable cardioverter defibrillator (ICD) and cardiac resynchronization with defbrillator devices (CRTd) implant. In this setting, the catheter ablation (CA) treatment has been used to reduce the ventricular arrhythmias and the ICD/CRTds' interventions, and to prevent mortality events in these' patients. On other hand, still a higher percentage of patients result as non responders to an ablative approach with higher acute and long term mortality rate. Therefore, in the present study in a population of HF patients (DM vs. non DM patients) affected by VA, authors will investigate the effects of CA on mortality rate at 12 months of follow up. In addition, authors would demonstrate the ameliorative effects of new hypoglycemic drugs in addition to CA in patients with DM. However, after CA the patients with DM will be randomly assigned to SGLT2 therapy vs. placebo. Indeed, study hypothesis will be that, a) DM vs. non DM patients might have higher mortality rate after CA; b) patients with DM treated by CA plus SLGT2 therapy vs. patients with DM treated by CA plus placebo might experience a lower rate of mortality at 1 year of follow-up.
Read the detailed description
SLGT2 therapy is safety used in heart failure (HF) patients with depressed left ventricle ejection fraction (LVEF) and diabetes mellitus (DM). Indeed, in these patients SGLT2 therapy reduces hospital admission for heart failure and mortality rate. To date, these patients experience higher rate of ventricular arrhythmias (VA), that are a leading cause of cardiac arrest and mortality. However, as indicated by international guidelines, these patients can be treated by implantable cardioverter defibrillator (ICD) and CRTd as primary and/or secondary prevention therapy. Consequently, the effectiveness of ICD and CRTd is to treat sustained VA, and to reduce cardiac arrest events and mortality. Indeed, ICDs/CRTds' anti-tachycardia pacing and shocks can interrupt VA, and this might prevent a cardiac arrest event. This therapeutic effect can positively impact on acute and long term patients' survival. On other hand, authors showed that, continuous VA events and ICDs' interventions are causes of reduced patients' life expectancy in HF patients. This worse prognosis is particularly evidenced in failing heart patients with DM as compared to patients without DM. In this setting, the catheter ablation (CA) treatment has been used to reduce the ventricular arrhythmias and the ICDs/CRTds' interventions, and to prevent mortality events in these patients. On other hand, still a higher percentage of patients result as non responders to an ablative approach with higher acute and long term mortality rate. Among these non responders patients to an ablative approach, DM is a negative prognostic factor. Therefore, in the present study in a population of HF patients (DM vs. non DM patients) with VA authors will investigate the effects of CA on mortality rate at 12 months of follow up. In addition, authors would like to demonstrate the ameliorative effects of new hypoglycemic drugs in addition to CA in patients with DM. However, after CA the patients with DM will be randomly assigned to SGLT2 therapy vs. placebo. Indeed, study hypothesis will be that, a) DM vs. non DM might have higher mortality rate after CA; b) patients with DM treated by CA plus SLGT2 therapy vs. patients with DM treated by CA plus placebo might experience a lower rate of mortality at 1 year of follow-up. Therefore, study aim will be to demonstrate a reduction of VA, ICDs/CRTds' interventions, and mortality in patients with DM treated by CA plus SLGT2 therapy vs. patients with DM treated by CA plus placebo at 12 months of follow-up.
- Conditions
- Diabetes Mellitus, Heart Failure, Ventricular Arrythmia
- Being tested
- SLGT2, Placebo
- Medical subject headings
- Diabetes Mellitus, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SLGT2Drug
These patients will receive SLGT2 therapy after catheter ablation.
PlaceboDrug
These patients will receive placebo therapy after catheter ablation.
| Study group | Role | What they receive |
|---|---|---|
| heart failure patients with diabetes treated by SGLT2 drugs | Experimental | Patients affected by heart failure and diabetes mellitus. These patients previous received an internal cardioverter defibrillator (ICD), and then a catheter ablation for ventricular arrhythmias (VA) therapy. After CA these patients received SLGT2 therapy. Receives: Drug: SLGT2 |
| heart failure patients with diabetes treated by placebo | Placebo comparator | Patients affected by heart failure and diabetes mellitus. These patients previous received an internal cardioverter defibrillator (ICD), and then a catheter ablation for ventricular arrhythmias (VA) therapy. After CA these patients received placebo therapy. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
all cause deaths
after the intervention authors will evaluate all cause of deahs
Measured: 12 months
cardiac deaths
after the intervention authors will evaluate the cause of cardiac deahs
Measured: 12 months
ventricular arrhythmias recurrence
after the intervention authors will evaluate the cases of ventricular arrhythmias recurrences
Measured: 12 months
Secondary outcomes (1)
hospitalization for heart failure worsening
after the intervention authors will evaluate the causes of hospital re-admission for heart failure worsening
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2019
- Study start1 Jan 2017
- Primary completion1 Jan 2019
- Study completion1 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campania Luigi Vanvitelli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Celestino Sardu, University of Campania Luigi Vanvitelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03977116
- Sponsor's protocol ID
- SecondUNI 05.06.2019
- Status last verified
- Feb 2020
- First submitted
- 5 Jun 2019
- Last updated
- 3 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes and Long Term Effects of Sodium-glucose Co-transporter 2 Inhibitors in Diabetes Mellitus and Failing Heart Patients With Implantable Cardioverter Defibrillator Undergoing Trans-catheter Ablation for Ventricular Arrhythmias.
- ClinicalTrials.gov ID
- NCT03977116
- Acronym / sponsor ID
- SecondUNI 05.06.2019
- Conditions
- Diabetes Mellitus, Heart Failure, Ventricular Arrythmia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of Campania Luigi VanvitelliUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 6 Jun 2019 (actual)
- 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.
SLGT2 therapy is safety used in heart failure (HF) patients with depressed left ventricle ejection fraction (LVEF) and diabetes mellitus (DM). These patients experience higher rate of ventricular arrhythmias (VA), that are a leading cause of cardiac arrest and mortality. However, these patients are treated by implantable cardioverter defibrillator (ICD) and cardiac resynchronization with defbrillator devices (CRTd) implant. In this setting, the catheter ablation (CA) treatment has been used to reduce the ventricular arrhythmias and the ICD/CRTds' interventions, and to prevent mortality events in these' patients. On other hand, still a higher percentage of patients result as non responders to an ablative approach with higher acute and long term mortality rate. Therefore, in the present study in a population of HF patients (DM vs. non DM patients) affected by VA, authors will investigate the effects of CA on mortality rate at 12 months of follow up. In addition, authors would demonstrate the ameliorative effects of new hypoglycemic drugs in addition to CA in patients with DM. However, after CA the patients with DM will be randomly assigned to SGLT2 therapy vs. placebo. Indeed, study hypothesis will be that, a) DM vs. non DM patients might have higher mortality rate after CA; b) patients with DM treated by CA plus SLGT2 therapy vs. patients with DM treated by CA plus placebo might experience a lower rate of mortality at 1 year of follow-up.
Detailed description
SLGT2 therapy is safety used in heart failure (HF) patients with depressed left ventricle ejection fraction (LVEF) and diabetes mellitus (DM). Indeed, in these patients SGLT2 therapy reduces hospital admission for heart failure and mortality rate. To date, these patients experience higher rate of ventricular arrhythmias (VA), that are a leading cause of cardiac arrest and mortality. However, as indicated by international guidelines, these patients can be treated by implantable cardioverter defibrillator (ICD) and CRTd as primary and/or secondary prevention therapy. Consequently, the effectiveness of ICD and CRTd is to treat sustained VA, and to reduce cardiac arrest events and mortality. Indeed, ICDs/CRTds' anti-tachycardia pacing and shocks can interrupt VA, and this might prevent a cardiac arrest event. This therapeutic effect can positively impact on acute and long term patients' survival. On other hand, authors showed that, continuous VA events and ICDs' interventions are causes of reduced patients' life expectancy in HF patients. This worse prognosis is particularly evidenced in failing heart patients with DM as compared to patients without DM. In this setting, the catheter ablation (CA) treatment has been used to reduce the ventricular arrhythmias and the ICDs/CRTds' interventions, and to prevent mortality events in these patients. On other hand, still a higher percentage of patients result as non responders to an ablative approach with higher acute and long term mortality rate. Among these non responders patients to an ablative approach, DM is a negative prognostic factor. Therefore, in the present study in a population of HF patients (DM vs. non DM patients) with VA authors will investigate the effects of CA on mortality rate at 12 months of follow up. In addition, authors would like to demonstrate the ameliorative effects of new hypoglycemic drugs in addition to CA in patients with DM. However, after CA the patients with DM will be randomly assigned to SGLT2 therapy vs. placebo. Indeed, study hypothesis will be that, a) DM vs. non DM might have higher mortality rate after CA; b) patients with DM treated by CA plus SLGT2 therapy vs. patients with DM treated by CA plus placebo might experience a lower rate of mortality at 1 year of follow-up. Therefore, study aim will be to demonstrate a reduction of VA, ICDs/CRTds' interventions, and mortality in patients with DM treated by CA plus SLGT2 therapy vs. patients with DM treated by CA plus placebo at 12 months of follow-up.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| heart failure patients with diabetes treated by SGLT2 drugs | Experimental | Drug: SLGT2Patients affected by heart failure and diabetes mellitus. These patients previous received an internal cardioverter defibrillator (ICD), and then a catheter ablation for ventricular arrhythmias (VA) therapy. After CA these patients received SLGT2 therapy. |
| heart failure patients with diabetes treated by placebo | Placebo comparator | Drug: PlaceboPatients affected by heart failure and diabetes mellitus. These patients previous received an internal cardioverter defibrillator (ICD), and then a catheter ablation for ventricular arrhythmias (VA) therapy. After CA these patients received placebo therapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- heart failure (HF) under optimal maximal drug therapy with NYHA functional II-III;
- HF with prior echocardiographic evidence of left ventricular systolic dysfunction (LVEF <35 % or subjective assessment of LV dysfunction that is mild or worse);
- patients under furosemide 80 mg daily or less, or equivalent loop diuretic;
- patients with stable HF symptoms for at least 3 months prior to consent;
- patients on stable therapy for HF for at least 3 months prior to consent;
Key exclusion criteria (13 listed)
- Patients without ICD;
- patients without previous event of ventricular arrhythmia (VA);
- patients without indication to receive catheter ablation (CA) for VA;
- patients with type 1 diabetes mellitus;
- severe hepatic disease, renal disease defined as chronic kidney disease stage 3b or worse (i.e. glomerular filtration rate <45 ml/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 |
|---|---|---|
| SLGT2These patients will receive SLGT2 therapy after catheter ablation. | Drug | heart failure patients with diabetes treated by SGLT2 drugs |
| PlaceboThese patients will receive placebo therapy after catheter ablation. | Drug | heart failure patients with diabetes treated by placebo |
Primary outcome
all cause deaths
Time frame: 12 months
after the intervention authors will evaluate all cause of deahs
cardiac deaths
Time frame: 12 months
after the intervention authors will evaluate the cause of cardiac deahs
ventricular arrhythmias recurrence
Time frame: 12 months
after the intervention authors will evaluate the cases of ventricular arrhythmias recurrences
1 secondary outcome
hospitalization for heart failure worsening
Time frame: 12 months
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 3 Mar 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing SLGT2 in people with Diabetes Mellitus and Heart Failure, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
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 11 inclusion and 13 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 3 Mar 2020. 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 Italy. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
all cause deaths (time frame: 12 months). The study lists 3 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 3 Mar 2020.