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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01022463

Acronym

IVA-MS

Enrollment

Registered

2009-12-01

Start date

2009-11-30

Completion date

2010-10-31

Last updated

2011-07-07

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

Conditions

Mitral Stenosis

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.

Interventions

DRUGIvabradine

Ivabradine 5 mg BId for 4 weeks

DRUGAtenolol

50 mg od for 4 weeks

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

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

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026