CTRI/2023/01/049086
Not yet recruiting
Phase 4
A Multicentric, Phase IV Clinical Trial to Evaluate Safety and Efficacy of Fixed Dose Combination of Carvedilol and Ivabradine Hydrochloride Tablet as a Substitution Therapy in Patients of Stable Chronic Heart Failure (CHF) with Systolic Dysfunction or in Patients of Stable Chronic Angina Pectoris.
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: I098- Other specified rheumatic heart diseases
- Sponsor
- Sun Pharma Laboratories Limited
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Patient of either gender, aged 18 to 65 years (both inclusive) and ready to give written informed consent to participate in the study at the time of screening
- •2\) Criteria specific for Stable Chronic Heart Failure (CHF) at screening
- •Patient with history of clinically stable chronic heart failure (NYHA class II to IV) with left ventricular systolic dysfunction for \>\= 4 weeks prior to screening
- •Patient with LVEF \<\= 35%
- •Patient concurrently receiving standard of care for chronic heart failure at stable doses for at least one month
- •3\) Criteria specific for Stable Chronic Angina Pectoris at screening
- •Patient with history of clinically stable chronic angina pectoris for at least 3 months prior to screening
- •Patient with coronary artery disease (documented by previous myocardial infarction, previous percutaneous or surgical coronary revascularisation, or angiographic evidence that one or more major coronary arteries had narrowed by 50% or more)
- •Patient concurrently receiving standard of care for Chronic Angina Pectoris at stable doses for at least one month
- •4\) Patient with sinus rhythm with clinically stable HR \> 50 bpm as assessed by automated standard 12 Lead ECG
Exclusion Criteria
- •1\. Patient who is Pacemaker dependent (heart rate imposed exclusively by the pacemaker) or with history of pacemaker, heart transplantation or on list of heart transplantation
- •2\. Patient with permanent atrial fibrillation or flutter or any other cardiac arrhythmias which may interfere with function of sinoatrial node
- •3\. Patient with sick sinus syndrome, sinoatrial block, congenital long QT or 2nd, 3rd degree and complete atrioventricular block
- •4\. Patient with stroke or transient cerebral ischemia within 3 months prior to screening
- •5\. Patient with unstable/decompensated or acute HF, Prinzmetalâ??s angina
- •6\. Acute myocardial infarction, Cardiogenic shock, Severe peripheral vascular disease (e.g. Raynaudâ??s phenomenon)
- •7\. Patient with severe hypotension (seated systolic blood pressure \<90 mmHg, seated diastolic blood pressure \<50 mmHg)
- •8\. Patient with uncontrolled hypertension (SeSBP \>\= 160 or SeDBP \>\= 100 mmHg) or uncontrolled diabetes (HbA1c Ë? 9%)
- •9\. Patient with chronic obstructive pulmonary disease associated with bronchial obstruction or with history of bronchospasm or asthma
- •10\. Patient with metabolic acidosis, untreated phaeochromocytoma
Outcomes
Primary Outcomes
Not specified
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