CompletedPhase 3

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

India50 participantsStarted 2009-11

Plain-language 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.

Who can participate

Age range18 Years – 70 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

Timeframe: 4 weeks

Trial details

NCT IDNCT01022463

SponsorGovind Ballabh Pant Hospital

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2010-10

View on ClinicalTrials.gov More Mitral Stenosis trials