NCT04117763CompletedPhase 4
Effect of Empagliflozin on Ventricular Repolarization.
Effect of EMPAgliflozin on The HeterogeneitY of Ventricular Repolarization in Patients With Diabetes and Coronary HEART Disease.
Source: ClinicalTrials.gov · Last updated 8 May 2024
Brief summary (registry, in English)
The present project aims to investigate if the empagliflozin has an antiarrhythmic action. Analyzing the T-wave heterogeneity index, a new electrocardiographic risk marker associated with the prediction of cardiovascular risk, in diabetic patients and coronary artery disease, the investigators will verify if empagliflozin is associated with a reduction in electrical instability.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 90 (actual)
- First submitted
- 3 Oct 2019
- Start date
- 4 Oct 2019
- Primary completion date
- 31 Mar 2024
- Lead sponsor
- University of Sao Paulo
- Diseases
- Coronary artery disease, Type 2 diabetes
- NCT number
- NCT04117763
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 90
- From 4 Oct 2019 to the primary completion date, 31 Mar 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Chronic renal insufficiency with glomerular filtration rate ≤ 45 ml / min / 1.73m2;
- Hepatic insufficiency (determined by Child-Pugh, B or C classification);
- 12-lead resting electrocardiogram with the following changes: intraventricular conduction disorders (bundle branch block), pacemaker rhythm, atrial fibrillation or flutter, artifact stroke distortion or baseline fluctuation
Age
- Age ≥ 85 years;
Who the study is looking for
- • Age ≥ 18 years;
- Fasting glycemia\> 100 mg/dl or previous diagnosis of type 2 diabetes mellitus;
- Coronary artery disease, defined by one of the following criteria: the antecedent of myocardial infarction; the evidence of significant coronary stenosis in previous coronary angiography; the noninvasive positive test for ischemia (stress electrocardiogram, stress echocardiogram, stress scintigraphy)
- TWH ≥ 80 microvolts
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| INCOR Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.