Real-World Effectiveness of Mavacamten in Canada (MAVEN)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Obstructive Hypertrophic Cardiomyopathy (oHCM)
• Intervention / Treatment: Drug: Mavacamten

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: BMS Study Connect Contact Center www.BMSStudyConnect.com; Phone Number: 855-907-3286; Email: Clinical.Trials@bms.com

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 5A5
      • London Health Science Centre (LHSC)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients treated with mavacamten; Patients with symptomatic obstructive hypertrophic cardiomyopathy (NYHA functional class II-III) who receive mavacamten as part of routine clinical care	Drug: Mavacamten; As detailed in the product label

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Up to 1.5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age		Baseline
Ethnicity		Baseline
Body mass index (BMI)		Baseline
Change in left ventricular outflow tract (LVOT) with Valsalva maneuver (vLVOT) gradient following mavacamten treatment initiation		Up to 1.5 years
Proportion of patients with left ventricular outflow tract (LVOT) with Valsalva maneuver gradient (vLVOT) < 20mmHg following mavacamten treatment initiation		Up to 1.5 years
Sex at birth		Baseline
Employment status		Baseline
Obstructive hypertrophic cardiomyopathy (oHCM) disease duration		Baseline
Proportion of patients in each New York Heart Association (NYHA) functional class II and III		Baseline
Left ventricular outflow tract (LVOT) with Valsalva maneuver (vLVOT) gradient		Baseline
Left ventricular ejection fraction by 2D echocardiogram (LVEFb)		Baseline
Mavacamten dose regimen		Up to 1.5 years
Proportion of patients who discontinued mavacamten		Up to 1.5 years
Duration of treatment prior to mavacamten discontinuation		Up to 1.5 years
Left ventricular ejection fraction by 2D echocardiogram (LVEF) at the time of mavacamten treatment discontinuation		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		Up to 1.5 years
Reason for discontinuing mavacamten treatment		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	Up to 1.5 years

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): August 31, 2024
• Study Completion (Estimated): August 31, 2024

Study Registration Dates

• First Submitted: March 25, 2024
• First Submitted That Met QC Criteria: March 25, 2024
• First Posted (Actual): March 29, 2024

Study Record Updates

• Last Update Posted (Actual): March 29, 2024
• Last Update Submitted That Met QC Criteria: March 25, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Cardiomyopathies; Cardiomyopathy, Hypertrophic
• Other Study ID Numbers: CV027-1137

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No