Health Condition 1: I509- Heart failure, unspecified
Conditions
Interventions
Intervention1: Carivalan: Dose- Carivalan (carvedilol/ivabradine SPC)
â?¢ 6.25 mg/5 mg
â?¢ 6.25 mg/7.5 mg
â?¢ 12.5 mg/5 mg
â?¢ 12.5 mg/7.5 mg
â?¢ 25 mg/5 mg
â?¢ 25 mg/7.5 mg
Frequency- Twice a da
Sponsors
Serdia Pharmaceuticals India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. 18 to 65 years old (both inclusive) 2. Patients receiving treatment for at least one of the following pathologies at the time of screening a. chronic coronary syndrome (CCS) with stable angina b. chronic heart failure (II-IV NYHA-class) with systolic dysfunction c. coexisting chronic coronary syndrome (CCS) with stable angina and chronic heart failure (II-IV NYHA-class) with systolic dysfunction 3. Receiving ivabradine and carvedilol bid separately at stable dose as individual tablets concomitantly since >= 3 months and controlled for the given pathologies 4. Concurrently receiving standard care for stable chronic HF (as per recommendation 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic HF) 5. Sinus rhythm with resting HR >50 bpm as assessed automatically by a standard 12-lead ECG 6. No physical limitation to ingest and retain oral medication 7. Willingness to participate in the study and provide written informed consent
Exclusion criteria
Exclusion criteria: 1. Contraindication to use of Carivalan® a. Patients hypersensitive to carvedilol, ivabradine or any of the other ingredients of this medicine, or to other beta blockers 2. Patients suffering from severe hepatic impairment 3. Concomitant use of Cytochrome p450 enzymes inducers (CYP3A4 inducer such as Rifampicin, Barbiturates, Phenytoin 4. History of recent acute MI, coronary revascularization, stroke, or transient ischemic attack 5. Scheduled for coronary revascularization, or likely to require surgery for valvular disease during the study period 6. Permanent atrial fibrillation or flutter or any other cardiac arrhythmias which may interfere with function of sinoatrial node 7. Patients suffering from acute or unstable /decompensated heart failure 8. Patients suffering from unstable angina (a severe form of angina in which chest pain occurs very frequently, with or without exercise) 9. Sick sinus syndrome, sinoatrial block, congenital long QT or treated with QT prolonging medications, 2nd degree and complete atrioventricular block 10. Stroke or transient cerebral ischemia within previous 11. Patients suffering from Prinzmetalâ??s angina (chest pain that occurs at rest and in cycles) 12. Patients suffering from a heart rhythm disorder, if your heart rate is too low (under 50 beats per minute) or if you feel weak, have decreased level of consciousness, shortness of breath, hypotension or chest pain (due to symptomatic or severe bradycardia) 13. Patients having a heart attack 14. Patients suffering from cardiogenic shock (a serious heart condition treated in hospitals and caused by very low blood pressure) 15. Patients heartbeat is exclusively regulated by pacemaker 16. Any cardiac condition which does not justify the inclusion of the patient in the study as per investigator discretion (e.g. severe primary valvular disease, active myocarditis, congenital heart disease, peripartum cardiomyopathy, etc.) 17. Patients having have a severe blood vessel disorder (for example Raynaudâ??s phenomenon) 18. Severe or uncontrolled hypertension (systolic BP [SBP] >= 190 mmHg or diastolic BP [DBP] >= 110 mmHg) uncontrolled hypotension (SBP 19. Uncontrolled blood glucose levels (random/post-prandial >= 200 mg/dL, fasting >= 126 mg/dL) 20. Patients suffering from chronic obstructive pulmonary disease or COPD (lung disease with symptoms such as wheeziness, difficulty in breathing and chronic cough) 21. Patients having already experienced breathing problems such as asthma or bronchospasm (difficulty in breathing due to the narrowing of the airways) 22. Patients having metabolic acidosis 23. Patient with high blood pressure mostly due to renal condition like pheochromocytoma 24. Patients receiving: a. medicines for treatment of fungal infections (such as ketoconazole, itraconazole) b. antibiotics used for bacterial infections (such as clarithromycin, erythromycin given orally josamycin and telithromycin) c. medicines called protease inhibitors used to treat HIV (such as nelfinavir, ritonavir) d. nefazodone (medicine to treat depression) e. diltiazem or
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Number of TEAEs recorded during the study 2.To determine compliance/ adherence to treatment at baseline and end of studyTimepoint: 1.Day 90 2.Day 0 & Day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Efficacy Endpoints : i- To evaluate Heart Rate in all patients ii- To record use of short-acting nitrates from baseline to end of study in CCS patients iii- To assess effectiveness of treatment on angina in CCS patients iv- To assess the overall health status in all patientsTimepoint: i- Day -15, Day 0, Day 15, Day 30 & Day 90 ii- Day -15, Day 0, Day 15, Day 30 & Day 90 iii- Day -15, Day 0, Day 15, Day 30 & Day 90 iv- Day -15, Day 0, Day 15, Day 30 & Day 90;Secondary Safety Endpoints: i-AEs and SAEs will be collected and evaluated ii- Assessment of resting HR for absence of bradycardia iii- Assessment of visual symptoms iv- Laboratory parameters v- Vital signsTimepoint: i- Day 90 ii- Day -15, Day 0, Day 15, Day 30 & Day 90 iii- Day -15, Day 0, Day 15, Day 30 & Day 90 iv- Day -15 & Day 90 v- Day -15, Day 0, Day 15, Day 30 & Day 90;Tolerability and adherence endpoints: i- WHO 6-domain questionnaire that evaluates general quality of life will be administered at baseline and end of study ii- VAS would be administered at baseline and end of study to evaluate treatment satisfaction iii- Investigatorâ??s assessment of test drug therapyTimepoint: i- Day 0 & Day 90 ii- Day 0 & Day 90 iii- Day 15, Day 30 & Day 90 | — |
Countries
India
Contacts
Public ContactDr Shariq Anwar
JSS Medical Research India Pvt. Ltd.
Outcome results
None listed