ClinicalTrials.gg
RecruitingNCT06551129COMPASS-HCMUpdated Nov 7, 2024

Real-world Patient Reported Outcomes Among Patients Treated With Camzyos

An observational study in Obstructive Hypertrophic Cardiomyopathy, sponsored by Bristol-Myers Squibb. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-07.

Sponsored by Bristol-Myers Squibb · Observational

From the registry’s dates

  • Started May 2024; still recruiting 2 years 6 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
118
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 26 studies in Cardiomyopathy, Hypertrophic by Bristol-Myers Squibb — 9 open to participants now, 14 under way, 1 of them phase 3. Cardiomyopathy, Hypertrophic · Bristol-Myers Squibb.

Planned enrollment
12th of 15
118 · median 200
Started
2024
with 5 others
Observational
15 of 26
9 open now
Primary completion
2026-12
later than 5 of 13 live
Registered
17th of 26
by date

Among the 26 studies in Cardiomyopathy, Hypertrophic by Bristol-Myers Squibb, this one is the 12th largest by planned enrollment of the 15 observational ones that give a count, is one of 6 that started in 2024, is one of 15 observational ones, reaches primary completion later than 5 of the 13 other live ones, and was the 17th registered.

Cardiomyopathy, Hypertrophic

363 studies on the registry are indexed under Cardiomyopathy, Hypertrophic; 116 are open to participants now.

Browse Cardiomyopathy, Hypertrophic studies →

Open to participants now

9 of the 26 studies in Cardiomyopathy, Hypertrophic by Bristol-Myers Squibb are open now, in 12 countries. Recruiting first, the newest first:

3 more — sign in →

By country, each count listing its studies:

All 9 open studies →

Who these studies take

Of the 81 Cardiomyopathy, Hypertrophic studies recruiting now, 55 (68%) set no upper age limit and 8 (10%) stop at 75 or younger; 21 take children under 18; 13 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 26 studies in Cardiomyopathy, Hypertrophic by Bristol-Myers Squibb, or all of them as a file.
02

Study summary

This real-world study will assess changes in health status among participants with symptomatic obstructive hypertrophic cardiomyopathy who are treated with mavacamten in the real world.

03

Conditions studied

  • Obstructive Hypertrophic Cardiomyopathy

Keywords

  • Obstructive Hypertrophic cardiomyopathy
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult participants in the United States diagnosed with obstructive hypertrophic cardiomyopathy (oHCM) receiving mavacamten treatment

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Participants ≥18 years of age.
  • Participants who are prescribed mavacamten for obstructive hypertrophic cardiomyopathy
  • Provided to participate in the study

Exclusion criteria

Exclusion Criteria:

  • Previously or currently enrolled in clinical trials for any cardiac myosin inhibitors
  • Treated for >7 days with mavacamten by the day of completing the baseline survey
  • Enrolled in any clinical trials at the time of or within the six-month period prior to the screening
  • Had heart attack requiring coronary artery bypass grafting within the three-month period prior to the screening
  • Had stroke or within the six-month period prior to the screening
  • Had moderate-to-severe lung disease which impacted the ability to perform daily activities of living and ability to breathe
  • Had major lung (thoracic) or heart (cardiac) surgery within the six-month period prior to the screening
  • Scheduled for a major surgery for the next three months, such as joint surgeries including hip replacement, abdominal surgeries, lung surgeries, heart surgeries, eye surgeries, brain surgeries, and any other major surgeries that require general anesthesia and at least an overnight hospital stay
  • Hospitalized requiring an overnight stay at the time of or within the two-week period prior to the screening
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
118 participants (estimated)
Patient registry
No

Groups and cohorts

  • Mavacamten

    Adult participants with symptomatic obstructive hypertrophic cardiomyopathy treated with mavacamten

    Drug: Mavacamten

Interventions

06

What researchers measure

Primary outcomes

  1. Participant Hypertrophic Cardiomyopathy symptoms as assessed by Hypertrophic Cardiomyopathy Symptom Questionnaire (HCMSQ v2,0 - 7-day recall version)

    Time frame: Baseline and weeks 2, 4, 8, 12, 24, 30, 48, 60, 72, 84 and 96

  2. Participant physical limitation, symptom stability, symptom frequency, symptom burden, self-efficacy, QoL, and social limitations as assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ-23)

    Time frame: Baseline and weeks 2, 4, 8, 12, 24, 30, 48, 60, 72, 84 and 96

  3. Participant mavacamten treatment status

    Time frame: Weeks 2, 4, 8, 12, 24, 30, 48, 60, 72, 84 and 96

  4. Other pharmacological and surgical treatments for obstructive hypertrophic cardiomyopathy (HCM)

    Time frame: Baseline and weeks 2, 4, 8, 12, 24, 30, 48, 60, 72, 84 and 96

  5. Participant symptom severity as assessed by self-assessed New York Heart Association (SA-NYHA) functional class

    Time frame: Baseline and weeks 2, 4, 8, 12, 24, 30, 48, 60, 72, 84 and 96

  6. Participant change in symptom severity as assessed by Patient Global Impression of Change (PGI-C)

    Time frame: Weeks 2, 4, 8, 12, 24, 30, 48, 72, and 96

  7. Participant septal reduction therapy

    Time frame: Baseline and weeks 12, 30, 48 and 96

  8. Participant major injury or surgery since previous survey

    Time frame: Weeks 2, 4, 8, 12, 24, 30, 48, 60, 72, 84 and 96

  9. Participant survey response on experience with CAMZYOS Risk Evaluation and Mitigation Strategy program (REMS) Program

    Time frame: Baseline and weeks 4, 12, 30, 48, 72 and 96

  10. Participant medical history

    Time frame: Baseline

07

Study locations

1 of 1 sites recruiting
  • Analysis Group Inc.
    Boston, Massachusetts 02199, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2024 (actual). Primary completion is estimated for Dec 2026, 31 months after the start.

Of 82 observational studies under Cardiomyopathy, Hypertrophic, half reached primary completion within 85 months of starting (the median), counting those still running; a quarter within 43. This study's planned 31 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 6, 2024
First posted
Aug 13, 2024
StartActual
May 10, 2024
Primary completionEst.
Dec 31, 2026
CompletionEst.
Jun 30, 2027
Last update
Nov 7, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 7, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06551129
Responsible party
Sponsor
First posted
Aug 13, 2024
Start date
May 10, 2024
Primary completion
Dec 31, 2026 (estimated)
Completion
Jun 30, 2027 (estimated)
Last update
Nov 7, 2024

Study contacts

BMS Study Connect Contact Center www.BMSStudyConnect.com
Contact
Clinical.Trials@bms.com
855-907-3286
First line of the email MUST contain NCT # and Site #.
Contact
Bristol-Myers Squibb
study director · Bristol-Myers Squibb

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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