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Study on safety and effectiveness, and usage of two drugs used for managing blood-pressure

An Observational, Parallel arm study to assess safety, clinical utilization and effectiveness of Bisoprolol or Metoprolol in stable coronary Artery Disease with reduced ejection fraction (CADBIS Study) - CADBIS Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/02/080038
Enrollment
40
Registered
2025-02-07
Start date
Unknown
Completion date
Unknown
Last updated
2025-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I251- Atherosclerotic heart disease of native coronary artery

Interventions

Intervention1: NIL: NIL Control Intervention1: NIL: NIL

Sponsors

Torrent Pharmaceuticals Ltd.
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male or Female patients 18 to 65 years. 2. An echocardiogram within six months prior inclusion which indicated an abnormally functioning or dilated left ventricle with (No angina, No NYHA class III or class IV). 3. Stable CAD cases confirmed with coronary angiography 4. Ejection fraction less than 40 percent with or without Atrial Fibrillation. 5. Known CAD cases with any comorbid risk factors. 6. Not on Beta Blockers therapy. 7. Patient willing to enroll for the study. 8. Patient on background medical therapy or no therapy.

Exclusion criteria

Exclusion criteria: 1. Hypersensitivity to Bisoprolol or Metoprolol. 2. Patients with mildly reduced or preserved ejection fraction. (greater than 40 percent) 3. Having a baseline heart rate less than 60 per min (sinus bradycardia). 4. Cardiogenic shock. 5. Second or third degree AV block. 6. Sick sinus syndrome. 7. Hepatic enzyme elevation X3 ULN. 8. For women only currently pregnant (confirmed with positive pregnancy test) or breastfeeding. 9. Stroke during last 30 days before enrolment. 10. Thromboembolic complications or thrombosis within 14 days before enrollment. 11. Use of psychoactive drugs.

Design outcomes

Primary

MeasureTime frame
1. Mean change in LVEF after 8 and 24 weeks of treatment. 2. Change in Blood Pressure (SBP & DBP) at 8 and 24 weeks from baseline. 3. Mean change in Heart rate (HR) from baseline to 8 and 24 weeks follow-up.Timepoint: At 8 weeks and 24 weeks—

Secondary

MeasureTime frame
Mean change in LV volume (End Diastolic Volume or Preload)Timepoint: At 8 weeks and 24 weeks;Mean change in LDL-C, HDL-C and Triglycerides level after 8 and 24 weeks from baselineTimepoint: At 8 weeks and 24 weeks;Mean change in comorbid risk factors (Dyslipidemia or HTN or T2DM)Timepoint: At 8 weeks and 24 weeks;Proportion of participants with treatment emergent adverse event during observation period.Timepoint: At 8 weeks and 24 weeks;Concomitant medicine prescribing trend for CADTimepoint: At 8 weeks and 24 weeks—

Countries

India

Contacts

Public ContactDr Rathish Nair

Torrent Pharmaceuticals Ltd.

krishnaprasadkorukonda@torrentpharma.com07069000572

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026