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

This study has been completed.
Information provided by:
Govind Ballabh Pant Hospital
ClinicalTrials.gov Identifier:
First received: November 25, 2009
Last updated: July 6, 2011
Last verified: November 2010
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.

Condition Intervention Phase
Mitral Stenosis
Drug: Ivabradine
Drug: Atenolol
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Govind Ballabh Pant Hospital:

Primary Outcome Measures:
  • Change in effort tolerance ( in minutes/Mets) from baseline with the study drugs at the end of stipulated 4 weeks [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: November 2009
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ivabradine
Crossover study to compare ivabradine and atenolol
Drug: Ivabradine
Ivabradine 5 mg BId for 4 weeks
Drug: Atenolol
50 mg od for 4 weeks
Placebo Comparator: Atenolol Drug: Atenolol
50 mg od for 4 weeks


Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01022463

G. B. Pant Hospital
New Delhi, Delhi, India, 110002
Sponsors and Collaborators
Govind Ballabh Pant Hospital
Principal Investigator: Dr Neeraj Parakh, MD, DM G. B. Pant Hospital, New Delhi
  More Information

Additional Information:
Responsible Party: Dr Neeraj Parakh, Govind Ballabh Pant hospital, New Delhi, India
ClinicalTrials.gov Identifier: NCT01022463     History of Changes
Other Study ID Numbers: F-2/IEC/MAMC/09/No.192 
Study First Received: November 25, 2009
Last Updated: July 6, 2011
Health Authority: India: Institutional Review Board

Additional relevant MeSH terms:
Constriction, Pathologic
Mitral Valve Stenosis
Cardiovascular Diseases
Heart Diseases
Heart Valve Diseases
Pathological Conditions, Anatomical
Adrenergic Agents
Adrenergic Antagonists
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Anti-Arrhythmia Agents
Antihypertensive Agents
Autonomic Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 24, 2016