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A CLINICAL TRIAL TO STUDY EFFECTS OF TWO DRUGS, ATENOLOL AND IVABRADINE IN PATIENTS WITH RHEUMATIC VALVULAR HEART DISEASE

A COMPARATIVE STUDY BETWEEN ATENOLOL AND IVABRADINE FOR HEART RATE CONTROL IN PATIENTS WITH MODERATE MITRAL STENOSIS WITH SINUS RHYTHM

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2012/10/003076
Enrollment
120
Registered
2012-10-29
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Moderate Mitral Stenosis with sinus rhythm

Interventions

Intervention1: 1.Atenolol 50 mg once daily 2.Ivabradine 5 mg twice daily: Atenolol 50 mg once daily will be given for 6 weeks for one arm ang Ivabradine 5 mg twice daily will be given for second arm

Sponsors

Dr Sajeer Kalathingathodika
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1)Patients with Mitral stenosis with a mitral valve area calculated by planimetry and/or pressure half time method between 1 and 1.5 cm 2 2)Age between 18 years and 60 years. 3)Normal sinus rhythm. 4)NYHA functional class I-II

Exclusion criteria

Exclusion criteria: 1)More than mild mitral regurgitation and aortic stenosis or aortic regurgitation. 2)Echo estimated PA systolic pressure more than 50 mmHg. 3)NYHA functional class III-IV 4)COPD, Bronchial asthma. 5)Inability to perform exercise or contra indications for TMT. 6)Known coronary artery heart disease. 7)Baseline LV systolic dysfunction (EF less than 50 %). 8)Any known contraindications/hypersensitivity to beta blocker or Ivabradine 9)Patients not willing to give consent

Design outcomes

Primary

MeasureTime frame
1.Change in the total duration of exercise in seconds from baseline TMT to post treatment TMT 2. Difference between the peak heart rate attained on baseline TMT and post treatment TMT Timepoint: 6 weeks

Secondary

MeasureTime frame
1. Change in the LV myocardial performance index by tissue Doppler imaging from baseline to post treatment period. 2. Change in the Left atrial appendage filling and emptying velocities and tissue Doppler velocities by Transesophageal echocardiography from baseline to post treatment period Timepoint: 6 weeks

Countries

India

Contacts

Public ContactDr sajeer Kalathingathodika

Dept.of Cardiology,Govt.Medical college, Kozhikode

kedaram@gmail.com9846697553

Outcome results

None listed

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