ERtugliflozin triAl in DIabetes with preserved or reduced ejeCtion FrAcTion;mEchanistic evaluation in Heart Failure: "ERADICATE-HF"
- Conditions
- diabetes mellitus type 2heart failure100192801001842410029149
- Registration Number
- NL-OMON50595
- Lead Sponsor
- Toronto General Hospital/University Health Network
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 18
Men and women with type 2 diabetes > 12 months, eGFR > 30 ml/min/1.73m2, age >
18 years, HbA1c 6.5 - 10.5%, BMI 18.5-45.0 kg, blood prssure < 160/110 and >
90/60 at screening, heart failure NYHA 2-3 with ejection fraction > 20%,
ACE/ARB-inhibition > 30 days, if diuretics are use then > 30 days before
baseline, BNP levels at baseline >100 pg/ml (no atrial fibrillation), >200
pg/ml if in atrial fibrillation, if NT-pro-BNP is used then a cut-off baseline
of >300ng/L (no atrial fibriallation) or >600 ng/L (in atrial fibrillation)
should be used
1. Type 1 Diabetes;2. Leukocyte and/or nitrite positive urinalysis that is
untreated;3. Severe hypoglycaemia within 2 months prior to screening;4. History
of brittle diabetes or hypoglycaemia unawareness based on investigator
judgement;5. Unstable coronary artery disease with acute coronary syndrome,
percutaneous intervention or bypass surgery within 3 months;6. Clinically
significant valvular disease;7. Congestive heart failure secondary to an
infiltrative cardiomyopathic process (for example amyloid) or pericardial
constriction;8. Uncontrolled systemic hypertension (systolic blood pressure
> 160 mmHg and/or diastolic blood pressure >110) or systemic
hypotension(systolic blood pressure < 90/60 mmHg);9. Bariatric surgery or
other surgeries that induce chronic malabsorption;10. Anti-obesity drugs or
diet regimen and unstable body weight three months prior to screening;11.
Treatment with systemic corticosteroids;12. Blood dyscrasias or any disorders
causing hemolysis or unstable red blood cells;13. Pre-menopausal women who are
nursing, pregnant, or of childbearing potential and not practicing an
acceptable method of birthcontrol;14. Participation in another trial with an
investigational drug within 30 days of informed consent;15. Alcohol or drug
abuse within three months prior to informed consent that would interfere with
trial participation or any ongoing clinicalcondition that would jeopardize
subject safety or study compliance based on investigator judgement;16. Liver
disease, defined by serum levels of alanine transaminase, aspartate
transaminase, or alkaline phosphatase >3 x upper limit ofnormal as
determined during screening;17. Active malignancy at the time of screening;18.
Allergy to iodine-based substances if receiving iohexol for GFR measureseen
stenose > 30% vertoont;
6. De doellae
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method