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

NCT ID: NCT01022463

Last Updated: 2011-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2010-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Mitral Stenosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ivabradine

Crossover study to compare ivabradine and atenolol

Group Type ACTIVE_COMPARATOR

Ivabradine

Intervention Type DRUG

Ivabradine 5 mg BId for 4 weeks

Atenolol

Intervention Type DRUG

50 mg od for 4 weeks

Atenolol

Group Type PLACEBO_COMPARATOR

Atenolol

Intervention Type DRUG

50 mg od for 4 weeks

Interventions

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Ivabradine

Ivabradine 5 mg BId for 4 weeks

Intervention Type DRUG

Atenolol

50 mg od for 4 weeks

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Govind Ballabh Pant Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Govind Ballabh Pant hospital, New Delhi, India

Principal Investigators

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Dr Neeraj Parakh, MD, DM

Role: PRINCIPAL_INVESTIGATOR

G. B. Pant Hospital, New Delhi

Locations

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G. B. Pant Hospital

New Delhi, National Capital Territory of Delhi, India

Site Status

Countries

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India

Other Identifiers

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

Identifier Type: -

Identifier Source: org_study_id

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