Study to Evaluate the Safety and Clinical Acceptability of the Carivalan® the Single Pill Combination (SPC) of Carvedilol/Ivabradine in Indian Patients with Chronic Heart Failure and/or Chronic Coronary Syndrome

Phase 4

• Conditions: Health Condition 1: I509- Heart failure, unspecified

• Registration Number: CTRI/2021/03/032399
• Lead Sponsor: Serdia Pharmaceuticals India Private Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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

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 <= 3 months), or with a transplanted heart, implanted pacemaker, implantable cardioverter defibrillator, or cardiac resynchronization therapy

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 <= 3 months prior at screening

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 <= 90 mmHg or DBP <= 50 mmHg)

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified