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

Govind Ballabh Pant Hospital50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Mitral Stenosis

Interventions

IvabradineDRUG

Ivabradine 5 mg BId for 4 weeks

AtenololDRUG

50 mg od for 4 weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

G. B. Pant Hospital

New Delhi, National Capital Territory of Delhi, India

Outcomes

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

Data from ClinicalTrials.gov

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