ClinicalTrials.gg
Not yet recruitingNCT07807384Updated Nov 12, 2026

Efficacy and Safety of an LVEF-Guided Mavacamten Dose Up-Titration Strategy in Chinese Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy

A Phase 4 interventional study of Mavacamten in Obstructive Hypertrophic Cardiomyopathy (oHCM), sponsored by Second Affiliated Hospital of Nanchang University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-12.

Sponsored by Second Affiliated Hospital of Nanchang University · Phase 4, Interventional, and Treatment

Updated Nov 12, 2026Start date movedPrimary completion moved+1 moreGo to Updates ↓
Phase
Phase 4
Study type
Interventional
Enrollment
115
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 21 studies testing MYK-461 in Cardiomyopathy, Hypertrophic — 3 open to participants now, 7 under way, 1 of them phase 3. MYK-461 · Cardiomyopathy, Hypertrophic.

Planned enrollment
6th of 21
115 · median 75
Started
2026
with 2 others
Phase 4
4 of 21
2 open now
Registered
21st of 21
by date
Lead sponsor
1 of 21
Second Affiliated Hospital of Nanchang University

Among the 21 studies testing MYK-461 in Cardiomyopathy, Hypertrophic, this one is the 6th largest by planned enrollment, is one of 3 that started in 2026, is one of 4 in phase 4, and was the 21st 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

3 of the 21 studies testing MYK-461 in Cardiomyopathy, Hypertrophic are open now, in 2 countries. Recruiting first, the newest first:

By country, each count listing its studies:

All 3 open studies →

About MYK-461

MYK-461: first FDA approval 2022 (CAMZYOS), first EMA approval 2023. What it is approved for, and how studies give it, is on its page →

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 →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 21 studies testing MYK-461 in Cardiomyopathy, Hypertrophic, or all of them as a file.
02

Study summary

This study aims to evaluate whether, under a treatment strategy primarily guided by left ventricular ejection fraction (LVEF), dose up-titration in adult patients with symptomatic obstructive hypertrophic cardiomyopathy who have received Mavacamten treatment for at least 12 weeks with a stable maintenance dose (as baseline) and with LVEF ≥55% can further reduce left ventricular outflow tract (LVOT) gradient after 24 weeks of treatment. It will also assess changes in hemodynamics, clinical symptoms, cardiac structure, and function. Furthermore, the study will conduct stratified analyses based on patients' baseline resting or Valsalva-provoked LVOT gradient levels at enrollment [\<30 mmHg vs. ≥30 mmHg] to explore differences in the aforementioned outcome measures among patients with different gradient levels, with the goal of providing evidence for individualized clinical dose adjustment.

03

Conditions studied

  • Obstructive Hypertrophic Cardiomyopathy (oHCM)
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

  • 1. Adult patients diagnosed with obstructive hypertrophic cardiomyopathy (HCM) and classified as (NYHA) functional class II-III. 2. Have received stable Mavacamten treatment for at least 12 weeks with a stable dose. 3. ≥ 55%.

Exclusion criteria

Exclusion Criteria:

  • 1. Hypertrophy caused by other systemic diseases with a clear etiology. 2. Planned use of strong CYP2C19 inhibitors, moderate to strong CYP2C19 inducers, or inducers during the study. 3. Planned use of disopyramide, ranolazine, verapamil combined with beta-blockers, or diltiazem combined with beta-blockers during the study. 4. Previous intolerance to Mavacamten. 5. Severe hepatic or renal dysfunction. 6. Pregnant or lactating women.
Terms in these criteria, in plain language(3)

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.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

CYP3A (CYP3A4) inhibitors and inducers

CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.

Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
115 participants (estimated)

Study arms

  • Experimental
    Mavacamten

    Drug: Mavacamten

Interventions

  • Eligible participants will undergo dose escalation at baseline from their current dose to the next higher level (once daily: 2.5 mg → 5 mg, 5 mg → 10 mg, or 10 mg → 15 mg). At Week 4, clinical status and echocardiography will be re-evaluated, and the same dose will be maintained for the subsequent 8 weeks, unless LVEF is \< 50%. After 12 weeks of treatment at the same dose level: If LVEF remains ≥ 55%, further dose escalation is permitted. If LVEF is between 50% and 55%, the current dose will be maintained. If LVEF is \< 50%, treatment will be interrupted/discontinued.

06

What researchers measure

Primary outcomes

  1. Change From Baseline in Valsalva Peak Left Ventricular Outflow Tract (LVOT) Pressure Gradient Assessed by Echocardiography at Week 24

    Time frame: Baseline, Week 4, Week 8, Week 12, and Week 24

Secondary outcomes

  1. Left Ventricular Wall Thickness

    Time frame: Baseline, Week 4, Week 8, Week 12, and Week 24

  2. Left Atrial Volume Index

    Time frame: Baseline, Week 4, Week 8, Week 12, and Week 24

  3. Left Ventricular Mass Index

    Time frame: Baseline, Week 4, Week 8, Week 12, and Week 24

  4. Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS)

    The Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) includes the physical limitation and total symptom domains. Scores range from 0 to 100, where higher scores indicate better health status, fewer symptoms, and less physical limitation (a better outcome).

    Time frame: Baseline and Week 24

  5. Mitral Regurgitation Severity

    Time frame: Baseline, Week 4, Week 8, Week 12, and Week 24

  6. Systolic Anterior Motion

    Time frame: Baseline, Week 4, Week 8, Week 12, and Week 24

  7. E/A Ratio

    Time frame: Baseline, Week 4, Week 8, Week 12, and Week 24

  8. Left Ventricular Ejection Fraction

    Time frame: Baseline, Week 4, Week 8, Week 12, and Week 24

  9. Left Atrial Volume Index

    Time frame: Baseline and Week 24

  10. Left Ventricular Wall Thickness

    Time frame: Baseline and Week 24

  11. New York Heart Association (NYHA) Functional Class

    Assessed by the New York Heart Association (NYHA) Functional Classification. The classification categorizes heart failure severity into four classes: Class I (no limitation of physical activity), Class II (slight limitation), Class III (marked limitation), and Class IV (unable to carry on any physical activity without discomfort). Scores range from Class I to Class IV, where higher classes indicate worse heart failure symptoms (a worse outcome)

    Time frame: Baseline, Week 4, Week 8, Week 12, and Week 24

  12. NT-proBNP

    Time frame: Baseline, Week 4, Week 8, Week 12, and Week 24

  13. Myocardial troponin

    Time frame: Baseline, Week 4, Week 8, Week 12, and Week 24

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it moved

Start is estimated for Nov 2026; primary completion for Sep 2029, 34 months later.

Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 12, 2026: start Sep 2026 → Nov 2026, primary completion Sep 2026 → Sep 2029 and completion Sep 2026 → Sep 2029.

Earlier changes are on the record history on ClinicalTrials.gov ↗

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

Registered
Aug 25, 2026
First posted
Sep 8, 2026
StartEst.
Nov 2026was Sep 2026
Primary completionEst.
Sep 2029was Sep 2026
CompletionEst.
Sep 2029was Sep 2026
Last update
Nov 12, 2026
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.
Start date
Sep 2026→Nov 2026
Nov 12, 2026
Primary completion
Sep 2026→Sep 2029
Nov 12, 2026
Study completion
Sep 2026→Sep 2029
Nov 12, 2026
Show all 1 update
  1. Nov 12, 2026
    Start date Sep 2026→Nov 2026
    Primary completion Sep 2026→Sep 2029
    Study completion Sep 2026→Sep 2029
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07807384
Lead sponsor
Second Affiliated Hospital of Nanchang University
Responsible party
Sponsor
First posted
Sep 8, 2026
Start date
Nov 2026 (estimated)
Primary completion
Sep 2029 (estimated)
Completion
Sep 2029 (estimated)
Last update
Nov 12, 2026

Study contacts

Ping Li
Contact
lipingsydeny@163.com
0791-86300545

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: MYK-461

Start the discussion