Back to resultsEffect of Ivabradine on Heart Rate & Effort Tolerance in Mitral Stenosis in Sinus Rhythm (IVA-MS)
Primary Purpose
Mitral Stenosis
Status
Completed
Phase
Phase 3
Locations
India
Study Type
Interventional
Intervention
Ivabradine
Atenolol
Sponsored by
About this trial
This is an interventional treatment trial for Mitral Stenosis
Eligibility Criteria
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
Sites / Locations
- G. B. Pant Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Ivabradine
Atenolol
Arm Description
Crossover study to compare ivabradine and atenolol
Outcomes
Primary Outcome Measures
Change in effort tolerance ( in minutes/Mets) from baseline with the study drugs at the end of stipulated 4 weeks
Secondary Outcome Measures
Full Information
NCT ID
NCT01022463
First Posted
November 25, 2009
Last Updated
July 6, 2011
Sponsor
Govind Ballabh Pant Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01022463
Brief Title
Effect of Ivabradine on Heart Rate & Effort Tolerance in Mitral Stenosis in Sinus Rhythm
Acronym
IVA-MS
Official Title
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
2. Study Status
Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Govind Ballabh Pant Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mitral Stenosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ivabradine
Arm Type
Active Comparator
Arm Description
Crossover study to compare ivabradine and atenolol
Arm Title
Atenolol
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Ivabradine
Intervention Description
Ivabradine 5 mg BId for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Atenolol
Intervention Description
50 mg od for 4 weeks
Primary Outcome Measure Information:
Title
Change in effort tolerance ( in minutes/Mets) from baseline with the study drugs at the end of stipulated 4 weeks
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Neeraj Parakh, MD, DM
Organizational Affiliation
G. B. Pant Hospital, New Delhi
Official's Role
Principal Investigator
Facility Information:
Facility Name
G. B. Pant Hospital
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110002
Country
India
12. IPD Sharing Statement
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Effect of Ivabradine on Heart Rate & Effort Tolerance in Mitral Stenosis in Sinus Rhythm
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