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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Mitral Stenosis Cardiovascular Diseases Heart Diseases Heart Valve Diseases Mitral Valve Stenosis

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

G. B. Pant Hospital

New Delhi, National Capital Territory of Delhi, 110002, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Ivabradine

Drug

Ivabradine 5 mg BId for 4 weeks

Atenolol

Drug

50 mg od for 4 weeks

Primary outcomes

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

Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Govind Ballabh Pant Hospital

Other Gov

Registry information

Official study title

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

Acronym: IVA-MS

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2010
First posted: Dec 1, 2009
Registry last updated: Jul 7, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed