Safety and efficacy of TRC4186 in the treatment of stable heart failure associated with HbA1c >= 6 % or type 2 diabetes receiving oral hypoglycaemic therapy (with or without additional insulin) as an add-on to conventional treatment for heart failure
- Conditions
- heart failure associated with impaired glucose tolerance or type 2 diabetes mellitusMedDRA version: 9.1Level: LLTClassification code 10019279Term: Heart failure
- Registration Number
- EUCTR2008-006237-27-GB
- Lead Sponsor
- Torrent Pharmaceuticals Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 300
1. Male and female subjects aged = 45 years. Female and male subjects must be of
non-childbearing or non-fertile potential, i.e. surgically sterile (bilateral
oophorectomy, hysterectomy, bilateral tubal ligation, vasectomy) or post-menopausal
for at least one year. Male subjects of fertile potential, must use an effective method
of birth control
2. Subjects with chronic heart failure stable for last 6 weeks (NYHA class II – III)
according to the criteria given in Appendix I (see section 15.1) and on stable
medication for heart failure for at least 2 weeks prior to screening, with no change in
drug or dose in that period.
3. Subjects with established type 2 diabetes mellitus (i.e. receiving oral therapy with or without insulin) or an impaired glucose tolerance (HbA1c should be =6.0% at
screening)
4. Subjects with NT-proBNP (N-terminal fragment of the a brain natriuretic peptide
(BNP)) = 400 pg/mL (subjects with atrial fibrillation NT-proBNP = 1200 pg/mL)
5. Subjects receiving a loop, thiazide or thiazide like diuretic (Metolazone,
Chlorthalidon, Indapamide and Xipamide) for treating heart failure (HF)
6. Subjects able to undergo cardiopulmonary exercise testing
7. Subjects able to communicate well with the investigator and to comply with the
requirements of the entire study
8. Subjects willing to give written informed consent (prior to any study-related
procedures being performed) and able to adhere to the study restrictions and
assessments schedule.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1. CHF caused by myocarditis, cor pulmonale, congenital heart disease, constrictive
pericarditis, or hypertrophic or restrictive cardiomyopathy.
2. Significant important hemodynamic disease in the investigators opinion, e.g. mitral
regurgitation and/or planned for surgery.
3. Acute coronary syndrome or coronary revascularization within 3 months
4. Angina as symptom limiting treadmill/bicycle exercise.
5. Evidence of myocardial ischemia which in the investigator’s opinion requires
investigation by angiography with a view to coronary revascularization
6. Presence of a left ventricular (LV) aneurysm.
7. History of ventricular fibrillation or symptomatic sustained ventricular tachycardia
without clear reversible precipitating cause (eg:- Severe hypokalemia [Serum
potassium < 3.0 mmol/L] or acute myocardial ischemia/ infarction) in past 12 months
unless treated with an implantable defibrillator.
8. Second-degree or third-degree heart block (unless treated with a pacemaker)
9. Patients scheduled for CRT or who have received CRT in past 3 months.
10. Left ventricular assist device (or an activated minute ventilation pacemaker)
11. Gross obesity (body mass index (BMI) > 40 kg/m2).
12. Pulmonary function (FEV1) less than 60 % of predicted or requiring long-term
corticosteroids.
13. Type I diabetes.
14. Severe joint disease or peripheral arterial disease sufficient to impede exercise
testing.
15. History of systemic and other vascular inflammatory disease.
16. Uncontrolled hypertension (systolic blood pressure = 160 mmHg under
antihypertensive treatment).
17. Screening liver enzyme test (AST or ALT) exceeding 3 times the upper limit of
normal range or hepatic impairment of Child-Pugh class C
18. Glomerular filtration rate (eGFR) < 30 ml/min.
19. Haemoglobin < 10.0 gm/dl
20. HbA1c > 10 %
21. Gastrointestinal disorder that could interfere with study drug absorption
22. Medical history of chronic hepatitis B, C
23. Medical history of HIV seropositivity
24. Pregnancy or nursing females
25. Any cancer disease, except non-invasive skin cancer (e. g. actinic keratosis or basal
cell carcinoma), or any other condition that may preclude full participation in the
study or that limit survival
26. Prior history of radiation and chemotherapy for malignancies
27. Known hypersensitivity to any ingredient of the study medication
28. Current participation (including prior 30 days) in any other therapeutic clinical trial
29. Unwilling or unable to comply with protocol
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method