Effect of Ivabradine on Heart Rate & Effort Tolerance in Mitral Stenosis in Sinus Rhythm (IVA-MS)

Govind Ballabh Pant Hospital

Status and phase: Completed; Phase 3

Conditions: Mitral Stenosis

Treatments: Drug: Atenolol; Drug: Ivabradine

Study type: Interventional

Funder types: Other

Identifiers

NCT01022463

F-2/IEC/MAMC/09/No.192

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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50 participants in 2 patient groups, including a placebo group

Ivabradine

Active Comparator group

Description:

Crossover study to compare ivabradine and atenolol

Treatment:

Drug: Ivabradine

Drug: Atenolol

Atenolol

Placebo Comparator group

Treatment:

Drug: Atenolol