Health Condition 1: I999- Unspecified disorder of circulatory system
Conditions
Interventions
None listed
Sponsors
Torrent Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1 Male or female patients 18 to 59 years 2 Known CAD cases requiring Bisoprolol 3 Known CAD cases with Comorbidities such as Hypertension or Diabetes 4 Patients willing follow up for 24 week at the same centre
Exclusion criteria
Exclusion criteria: 1 Hypersensitivity to Bisoprolol 2 Acute heart failure or during episodes of heart failure decompensation requiring IV Inotropic therapy 3 Cardiogenic shock 4 Second or third degree AV block 5 Sick sinus syndrome 6 Hepatic enzyme elevation X3 ULN 7 For women only currently pregnant confirmed with positive pregnancy test or breast feeding 8 Sexually active woman of childbearing age not practicing accepted birth control method
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 Mean changes from baseline in Heart Rate HR and Left Ventricular ejection fraction LVEF level at 24 weekTimepoint: 1 Baseline day 0 to 24 week | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 Proportion of participants with treatment emergent adverse event during observation period 2 Change for HR and LVEF in CAD cases with Hypertension at 24 week 3 Change in Blood pressure at 24 weekTimepoint: 1 Baseline Day 0 and 24 weeks 2 Baseline Day 0 and 24 weeks 3 Baseline Day 0 and 24 weeks | — |
Countries
India
Contacts
Public ContactDr Krishnaprasad K
Swarna Heart Clinic
Outcome results
None listed