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NCT01022463 Clinical Trial

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

Mitral Stenosis Clinical Trial

— IVA-MS  

Official title:
Effect of Ivabradine vs Atenolol on Heart Rate and Effort Tolerance in Patients With Mild to Moderate Mitral Stenosis and Normal Sinus Rhythm

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01022463
Other study ID # F-2/IEC/MAMC/09/No.192
Secondary ID
Status Completed
Phase Phase 3
First received November 25, 2009
Last updated July 6, 2011
Start date November 2009
Est. completion date October 2010

Study information
Verified date November 2010
Source Govind Ballabh Pant Hospital
Contact n/a
Is FDA regulated No
Health authority India: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date October 2010
Est. primary completion date October 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Ivabradine
Ivabradine 5 mg BId for 4 weeks
• Atenolol
50 mg od for 4 weeks

Locations
Country Name City State
India G. B. Pant Hospital New Delhi Delhi

Sponsors (1)
Lead Sponsor Collaborator
Govind Ballabh Pant Hospital

Country where clinical trial is conducted

India, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in effort tolerance ( in minutes/Mets) from baseline with the study drugs at the end of stipulated 4 weeks 4 weeks No
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