Effect of Ivabradine on Heart Rate & Effort Tolerance in Mitral Stenosis in Sinus Rhythm

Phase 3

Completed

• Conditions: Mitral Stenosis
• Interventions: Drug: Ivabradine; Drug: Atenolol

• Registration Number: NCT01022463
• Lead Sponsor: Govind Ballabh Pant Hospital

Brief Summary

The purpose of this study is to study the effect of Ivabradine vs Atenolol on heart rate and effort tolerance in patients with mild to moderate mitral stenosis and normal sinus rhythm.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-11-25
• Study First Submitted QC: 2009-11-30
• Study First Posted: 2009-12-01
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Status Verified: 2010-11
• Last Update Submitted: 2011-07-06
• Last Update Posted: 2011-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Mild to moderate mitral stenosis (Mitral valve area: 1.0 cm2 - 2.0 cm2 on echocardiography) with normal sinus rhythm
2. Age >18 years
3. Need for rate control therapy for symptoms

Exclusion Criteria

1. Atrial fibrillation
2. Other significant valvular lesions (More than mild AS/AR/MR)
3. Denial of consent
4. Unable to do TMT/Contraindication for TMT
5. Need for surgical treatment or BMV
6. Presence of significant non-cardiac co-morbidities
7. Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Ivabradine	Ivabradine	Crossover study to compare ivabradine and atenolol
Ivabradine	Atenolol	Crossover study to compare ivabradine and atenolol
Atenolol	Atenolol	-

Primary Outcome Measures

Name	Time	Method
Change in effort tolerance ( in minutes/Mets) from baseline with the study drugs at the end of stipulated 4 weeks	4 weeks

Trial Locations

Locations (1)

G. B. Pant Hospital; 🇮🇳 New Delhi, Delhi, India