NCT01022463

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2009

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

November 25, 2009

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 1, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

July 7, 2011

Status Verified

November 1, 2010

Enrollment Period

11 months

First QC Date

November 25, 2009

Last Update Submit

July 6, 2011

Conditions

Mitral Stenosis

Outcome Measures

Primary Outcomes (1)

  • Change in effort tolerance ( in minutes/Mets) from baseline with the study drugs at the end of stipulated 4 weeks

    4 weeks

Study Arms (2)

Ivabradine

ACTIVE COMPARATOR

Crossover study to compare ivabradine and atenolol

Drug: IvabradineDrug: Atenolol

Atenolol

PLACEBO COMPARATOR
Drug: Atenolol

Interventions

IvabradineDRUG

Ivabradine 5 mg BId for 4 weeks

Ivabradine
AtenololDRUG

50 mg od for 4 weeks

AtenololIvabradine

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

G. B. Pant Hospital

New Delhi, National Capital Territory of Delhi, 110002, India

Location

MeSH Terms

Conditions

Mitral Valve Stenosis

Interventions

IvabradineAtenolol

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

BenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAmines

Study Officials

  • Dr Neeraj Parakh, MD, DM

    G. B. Pant Hospital, New Delhi

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

November 25, 2009

First Posted

December 1, 2009

Study Start

November 1, 2009

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

July 7, 2011

Record last verified: 2010-11

Locations

IN(1)