A Phase II clinical trial to study the effects of TRC4186, an investigational new drug in patients with stable heart failure associated with HbA1C â?¥ 6.0% or type 2 diabetes mellitus receiving oral anti-diabetic drug with or without insulin.
- Conditions
- Health Condition 1: null- Chronic heart failure associated with impaired glucose tolerance
- Registration Number
- CTRI/2009/091/000043
- Lead Sponsor
- Torrent Pharmaceutical Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 300
Salient Inclusion Criteria
•Subjects of either sex, aged >= 45 years.
•Subjects with chronic heart failure, stable for 6 weeks (NYHA class II or III) according to criteria of ESC and on stable medication for heart failure for at least 2 weeks prior to screening.
•Subjects with 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).
•Subjects with an NT-proBNP >= 400 pg/mL (subjects with atrial fibrillation NT-proBNP >= 1200 pg/mL)
•Subjects receiving at least loop, thiazide or thiazide like diuretic for treating HF
•Subjects able to undergo cardiopulmonary exercise testing
Salient Exclusion Criteria
•CHF caused by myocarditis, cor pulmonale, congenital heart disease, constrictive pericarditis, or hypertrophic or restrictive cardiomyopathy.
•Acute coronary syndrome or coronary revascularization within 3 months
•Second-degree or third-degree heart block (unless treated with a pacemaker)
•Pulmonary function (FEV1) less than 60 % of predicted or requiring long-term corticosteroids.
•Left ventricular assist device (or an activated minute ventilation pacemaker)
•Uncontrolled hypertension (systolic blood pressure >= 160 mmHg under antihypertensive treatment).
•Glomerular filtration rate (eGFR) 30 ml/min.
•Unwilling or unable to comply with protocol
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method