Obstructive Hypertrophic Cardiomyopathy (oHCM)MAVENNCT06338202
Real-World Effectiveness of Mavacamten in Canada
An observational study of Obstructive Hypertrophic Cardiomyopathy (oHCM), run by Bristol-Myers Squibb at 1 site in Canada.
Trial summary
The purpose of this observational, retrospective, physician survey study is to describe the real-world effectiveness and use of mavacamten in participants who initiated treatment for obstructive hypertrophic cardiomyopathy (oHCM) in Canada. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Hypertrophic Cardiomyopathy (oHCM)
- What is being tested?
- Mavacamten
- How many people
- 115 participants
- Where
- 1 siteCanada
- Study dates
- 24 Jun 2024to 19 Dec 2024
- Phase
- Observational
- 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 years and older
- All sexes
- Adult, Older adult
Study population: The observational study will include adult patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) who are enrolled in the Bristol Myers Squibb (BMS)-sponsored CAMZYOS Patient Support Program and who have initiated mavacamten as part of routine clinical care in Canada.
Who may be able to join
- Patients who have initiated mavacamten, as part of routine clinical care, through the Bristol Myers Squibb CAMZYOS Patient Support Program for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (oHCM)
- Adult patient (≥18 years of age or as defined per local province/territory) at Index Date (first prescribed dose of mavacamten).
- Patient has been diagnosed with symptomatic oHCM of New York Heart Association (NYHA) class II to III at the time of mavacamten initiation.
Who cannot join
- In the 6 weeks prior to baseline (i.e., Index Date; date of first prescribed dose of mavacamten), patient has received any cardiac myosin inhibitor (including mavacamten) for oHCM or any other medical condition as part of a clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Real-World Effectiveness of MAVacamtEN in Canada (MAVEN): A Retrospective Physician Survey of Patient Charts
The purpose of this observational, retrospective, physician survey study is to describe the real-world effectiveness and use of mavacamten in participants who initiated treatment for obstructive hypertrophic cardiomyopathy (oHCM) in Canada.
- Being tested
- Mavacamten
- Medical subject headings
- Cardiomyopathy, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MavacamtenDrug
As detailed in the product label
| Study group | Role | What they receive |
|---|---|---|
| Patients treated with mavacamten | Patients with symptomatic obstructive hypertrophic cardiomyopathy (NYHA functional class II-III) who receive mavacamten as part of routine clinical care Receives: Drug: Mavacamten |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in New York Heart Association (NYHA) functional class following mavacamten treatment initiation
- Proportion of patients in each New York Heart Association (NYHA) functional class following mavacamten treatment initiation
- Proportion of patients with a reduction of ≥1 New York Heart Association (NYHA) functional class following mavacamten treatment initiation
Measured: Up to 1.5 years
Secondary outcomes (18)
Change in left ventricular outflow tract (LVOT) with Valsalva maneuver (vLVOT) gradient following mavacamten treatment initiation
Measured: Up to 1.5 years
Proportion of patients with left ventricular outflow tract (LVOT) with Valsalva maneuver gradient (vLVOT) < 20mmHg following mavacamten treatment initiation
Measured: Up to 1.5 years
Age
Measured: Baseline
Sex at birth
Measured: Baseline
Ethnicity
Measured: Baseline
Employment status
Measured: Baseline
Body mass index (BMI)
Measured: Baseline
Obstructive hypertrophic cardiomyopathy (oHCM) disease duration
Measured: Baseline
Proportion of patients in each New York Heart Association (NYHA) functional class II and III
Measured: Baseline
Left ventricular outflow tract (LVOT) with Valsalva maneuver (vLVOT) gradient
Measured: Baseline
Left ventricular ejection fraction by 2D echocardiogram (LVEFb)
Measured: Baseline
Mavacamten dose regimen
Measured: Up to 1.5 years
Proportion of patients who discontinued mavacamten
Measured: Up to 1.5 years
Duration of treatment prior to mavacamten discontinuation
Measured: Up to 1.5 years
Left ventricular ejection fraction by 2D echocardiogram (LVEF) at the time of mavacamten treatment discontinuation
Measured: Up to 1.5 years
Proportion of patients with left ventricular ejection fraction by 2D echocardiogram (LVEF) < 50% at the time of mavacamten treatment discontinuation
Measured: Up to 1.5 years
Reason for discontinuing mavacamten treatment
Measured: Up to 1.5 years
Functional assessment schedule
- Proportion of patients who undergo left ventricular outflow tract with Valsalva maneuver gradient (vLVOT) functional assessment
- Proportion of patients who undergo left ventricular ejection fraction (LVEF) assessment
Measured: Up to 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2024
- Study start24 Jun 2024
- Primary completion12 Nov 2024
- Study completion19 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Hypertrophic Cardiomyopathy (oHCM)Studies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06338202
- Sponsor's protocol ID
- CV027-1137
- Acronym
- MAVEN
- Status last verified
- Nov 2025
- First submitted
- 25 Mar 2024
- Last updated
- 4 Dec 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Effectiveness of MAVacamtEN in Canada (MAVEN): A Retrospective Physician Survey of Patient Charts
- ClinicalTrials.gov ID
- NCT06338202
- Acronym / sponsor ID
- MAVEN / CV027-1137
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 24 Jun 2024 (actual)
- Primary completion
- 12 Nov 2024 (actual)
- Study completion
- 19 Dec 2024 (actual)
- First posted
- 29 Mar 2024 (actual)
- 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 observational, retrospective, physician survey study is to describe the real-world effectiveness and use of mavacamten in participants who initiated treatment for obstructive hypertrophic cardiomyopathy (oHCM) in Canada.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients treated with mavacamten | – | Drug: MavacamtenPatients with symptomatic obstructive hypertrophic cardiomyopathy (NYHA functional class II-III) who receive mavacamten as part of routine clinical care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The observational study will include adult patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) who are enrolled in the Bristol Myers Squibb (BMS)-sponsored CAMZYOS Patient Support Program and who have initiated mavacamten as part of routine clinical care in Canada.
Key inclusion criteria (3 listed)
- Patients who have initiated mavacamten, as part of routine clinical care, through the Bristol Myers Squibb CAMZYOS Patient Support Program for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (oHCM)
- Adult patient (≥18 years of age or as defined per local province/territory) at Index Date (first prescribed dose of mavacamten).
- Patient has been diagnosed with symptomatic oHCM of New York Heart Association (NYHA) class II to III at the time of mavacamten initiation.
Key exclusion criteria (1 listed)
- In the 6 weeks prior to baseline (i.e., Index Date; date of first prescribed dose of mavacamten), patient has received any cardiac myosin inhibitor (including mavacamten) for oHCM or any other medical condition as part of a clinical trial.
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 |
|---|---|---|
| MavacamtenAs detailed in the product label | Drug | Patients treated with mavacamten |
Primary outcome
Change in New York Heart Association (NYHA) functional class following mavacamten treatment initiation
Time frame: Up to 1.5 years
* Proportion of patients in each New York Heart Association (NYHA) functional class following mavacamten treatment initiation * Proportion of patients with a reduction of ≥1 New York Heart Association (NYHA) functional class following mavacamten treatment initiation
18 secondary outcomes
Change in left ventricular outflow tract (LVOT) with Valsalva maneuver (vLVOT) gradient following mavacamten treatment initiation
Time frame: Up to 1.5 years
Proportion of patients with left ventricular outflow tract (LVOT) with Valsalva maneuver gradient (vLVOT) < 20mmHg following mavacamten treatment initiation
Time frame: Up to 1.5 years
Age
Time frame: Baseline
Sex at birth
Time frame: Baseline
Ethnicity
Time frame: Baseline
Employment status
Time frame: Baseline
Body mass index (BMI)
Time frame: Baseline
Obstructive hypertrophic cardiomyopathy (oHCM) disease duration
Time frame: Baseline
Proportion of patients in each New York Heart Association (NYHA) functional class II and III
Time frame: Baseline
Left ventricular outflow tract (LVOT) with Valsalva maneuver (vLVOT) gradient
Time frame: Baseline
Left ventricular ejection fraction by 2D echocardiogram (LVEFb)
Time frame: Baseline
Mavacamten dose regimen
Time frame: Up to 1.5 years
Proportion of patients who discontinued mavacamten
Time frame: Up to 1.5 years
Duration of treatment prior to mavacamten discontinuation
Time frame: Up to 1.5 years
Left ventricular ejection fraction by 2D echocardiogram (LVEF) at the time of mavacamten treatment discontinuation
Time frame: Up to 1.5 years
Proportion of patients with left ventricular ejection fraction by 2D echocardiogram (LVEF) < 50% at the time of mavacamten treatment discontinuation
Time frame: Up to 1.5 years
Reason for discontinuing mavacamten treatment
Time frame: Up to 1.5 years
Functional assessment schedule
Time frame: Up to 1.5 years
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 4 Dec 2025.
- BMS Clinical Trial InformationLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Hypertrophic Cardiomyopathy (oHCM), run by Bristol-Myers Squibb at 1 site in Canada.
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 1 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 4 Dec 2025. 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 Canada. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 New York Heart Association (NYHA) functional class following mavacamten treatment initiation (time frame: Up to 1.5 years). 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 4 Dec 2025.