Mitral StenosisPhase 3IVA-MSNCT01022463
Effect of Ivabradine on Heart Rate & Effort Tolerance in Mitral Stenosis in Sinus Rhythm
A Phase 3 study testing Ivabradine and Atenolol in people with Mitral Stenosis, run by Govind Ballabh Pant Hospital at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Mitral Stenosis
- What is being tested?
- Ivabradine and Atenolol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteIndia
- Study dates
- Nov 2009to Oct 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
India1 site
G. B. Pant Hospital
New Delhi, National Capital Territory of Delhi, 110002
About this study
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
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.
- Conditions
- Mitral Stenosis
- Being tested
- Ivabradine, Atenolol
- Medical subject headings
- Mitral Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IvabradineDrug
Ivabradine 5 mg BId for 4 weeks
AtenololDrug
50 mg od for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Ivabradine | Active comparator | Crossover study to compare ivabradine and atenolol Receives: Drug: Ivabradine; Drug: Atenolol |
| Atenolol | Placebo comparator | Not described Receives: Drug: Atenolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in effort tolerance ( in minutes/Mets) from baseline with the study drugs at the end of stipulated 4 weeks
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2009 (estimated)
- Study startNov 2009
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Govind Ballabh Pant Hospital
- Sponsor type
- Other government
- Investigators
- Dr Neeraj Parakh, MD, DM, Principal investigator, G. B. Pant Hospital, New Delhi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01022463
- Sponsor's protocol ID
- F-2/IEC/MAMC/09/No.192
- Acronym
- IVA-MS
- Status last verified
- Nov 2010
- First submitted
- 25 Nov 2009
- Last updated
- 7 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01022463
- Acronym / sponsor ID
- IVA-MS / F-2/IEC/MAMC/09/No.192
- Conditions
- Mitral Stenosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Govind Ballabh Pant HospitalOther government
- Study start
- Nov 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 1 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ivabradine | Active comparator | Drug: Ivabradine, Drug: AtenololCrossover study to compare ivabradine and atenolol |
| Atenolol | Placebo comparator | Drug: Atenolol |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IvabradineIvabradine 5 mg BId for 4 weeks | Drug | Ivabradine |
| Atenolol50 mg od for 4 weeks | Drug | Atenolol, Ivabradine |
Primary outcome
Change in effort tolerance ( in minutes/Mets) from baseline with the study drugs at the end of stipulated 4 weeks
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Neeraj Parakh, MD, DM principal investigator
G. B. Pant Hospital, New Delhi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ivabradine and Atenolol in people with Mitral Stenosis, run by Govind Ballabh Pant Hospital at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in effort tolerance ( in minutes/Mets) from baseline with the study drugs at the end of stipulated 4 weeks (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2011.