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Ivabradine versus atenolol in patients with mitral valve stenosis

Effects of ivabradine compared with atenolol on exercise tolerance in patients with mitral stenosis in sinus rhythm

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2012/07/002781
Enrollment
40
Registered
2012-07-10
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- mitral stenosis patients with sinus rhythm

Interventions

Intervention1: ivabradine: ivabradine-5 mg PO bd for 15 days followed by 7.5 mg PO bd for 30 days. It is a drug being used for rate control in CHF and chronic stable angina with proven efficacy. Becau

Sponsors

The Director
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Treatment naïve or on pharmacological treatment patients with mitral stenosis (Mitral valve area: 2. Age >18 years of either sex 3. Need for rate control therapy for symptoms 4. Willing to give written informed consent

Exclusion criteria

Exclusion criteria: 1. Atrial fibrillation , Atrial flutter 2. Other significant valvular lesions (More than mild AS/AR/MR) or cardiac conditions ( CAD, active rheumatic carditits or myocarditis, cardiomyopathy) 3. Unable to do TMT/Contraindication for TMT 4. Need for immediate surgical treatment or BMV 5. Presence of significant noncardiac comorbidities- anemia, deranged RFT 6. Pregnancy 7. Congestive heart failure stage IV NYHA; 8. Second/third degree AV block, 9. Resting HR less than or equal to 50 bpm or sick sinus syndrome; 10. Contraindications to atenolol or ivabradine

Design outcomes

Primary

MeasureTime frame
1. Change from baseline in the total duration of exerciseTimepoint: On day 15 and on day 45 after initiating therapy

Secondary

MeasureTime frame
change from baseline in maximum METs achieved, peak heart rate, time to onset of dyspnea and fatigue, time to limiting dyspnea and fatigue, respiratory rate during 1st minute into recovery, transmitral gradient and pulmonary artery pressuresTimepoint: On day 15 and on day 45 after initiating therapy

Countries

India

Contacts

Public ContactDr Manoj Kumar Rohit

PGIMER

drkiranchulki@yahoo.co.in09781028877

Outcome results

None listed

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