Computed from this object's own state — a structural condition is unmet. This is not a fixed disclaimer: the conditions below are each testable, and a build in which they are met renders READY.
Three trials, three unrelated registered primaries: a responder composite, a septal-reduction-therapy decision, and a continuous pressure gradient.
In this section: Registration and administrative information (PROSPERO field set) · What this object claims to contain
| Review title | Mavacamten in hypertrophic cardiomyopathy |
|---|---|
| Review question (PICO) | Three trials, three unrelated registered primaries: a responder composite, a septal-reduction-therapy decision, and a continuous pressure gradient. |
| Population | Adults with symptomatic obstructive HCM (NYHA II-III) |
| Intervention | Mavacamten (dose-adjusted to achieve LVOT gradient <30 mmHg) |
| Comparator | Placebo |
| Background / rationale | Not recorded — this object holds no background field, and an introduction generated without one would be argument that no source in this review supports |
| Eligibility criteria | not recorded on the page this object was built from |
| Information sources | 0 source layers, listed on the Extraction tab |
| Search strategy | The executed strings, datetimes, filters and hit counts are on the Search tab |
| Study selection process | Not recorded — no screening record was recoverable from the page this object was extracted from, so who screened and how cannot be stated |
| Number of screeners | Not recorded — this object records no screener count |
| Data extraction items | Extracted per trial on this object: registry id; primary publication; arms; per-arm counts and the published effect. Fields not listed here were not extracted. |
| Outcomes and prioritisation | Three unrelated registered primaries |
| Risk of bias method | Not recorded — no per-domain RoB-2 assessment exists yet |
| Synthesis methods | Not recorded — no outcome on this object carries a pooled estimate, so no synthesis method was applied |
| Subgroup analyses | Not recorded — this object records no subgroup-analysis field at all, so whether any were prespecified is UNKNOWN -- which is not the same as none having been |
| Meta-bias assessment | Not recorded — no funnel, Egger or Peters value is held on this object, so no meta-bias assessment is claimed |
| Certainty assessment | Not recorded — no GRADE record was recoverable from the page this object was extracted from |
| Funding | Not recorded — no funding statement is recorded for this review |
| Competing interests | Not recorded — no declaration is recorded |
| Built | 2026-08-18T00:00Z |
| Schema | 2-authored-from-source |
not recorded on the page this object was built from
In this section: Extracted values, and where each came from · References · Included studies · Regulatory documents · Methods and guidance · Sources · Three unrelated registered primaries · Three unrelated registered primaries · What was measured · Pooled result · Contributing trials · Endpoint definitions, read from the registry
One row per extracted value. Every row carries the value, the verbatim sentence it was read from, a resolvable link to the source, and whether the number was read or derived. Where any of those is absent the row says so rather than omitting the value.
| Trial / outcome | Value as extracted | Verbatim source sentence | Source links | Read or derived |
|---|---|---|---|---|
| EXPLORER-HCM primary | no effect value held for this outcome | no source sentence recorded — this value cannot be checked against a quoted line here | NCT03470545 · source | DERIVED by us from not carried forward -- the estimate is withdrawn The counts above are what the page held for this trial. The endpoint definition beside them is verbatim from the registry, and is what the withdrawal turns on. |
| VALOR-HCM primary | no effect value held for this outcome | no source sentence recorded — this value cannot be checked against a quoted line here | NCT04349072 · source | DERIVED by us from not carried forward -- the estimate is withdrawn The counts above are what the page held for this trial. The endpoint definition beside them is verbatim from the registry, and is what the withdrawal turns on. |
| Chinese phase 3 primary | no effect value held for this outcome | no source sentence recorded — this value cannot be checked against a quoted line here | NCT05174416 · source | DERIVED by us from not carried forward -- the estimate is withdrawn The counts above are what the page held for this trial. The endpoint definition beside them is verbatim from the registry, and is what the withdrawal turns on. |
| Layer | Source | How it was obtained |
|---|
| Comparator | placebo |
|---|---|
| Estimand | mixed — random-effects |
| Effect scale | reported on the log scale; nothing is pooled on this outcome |
What this does not establish: not that mavacamten does not work in obstructive hypertrophic cardiomyopathy. The trials here measure a responder composite, a treatment decision, and a pressure gradient, and nothing on this page estimates the question its title implies. What is confirmed: explorer-hcm's stored counts, 45 of 123 against 22 of 128, ARE its registered responder counts -- the one row here that is right. All three identities are correct. The original reason is upheld as far as it went and is superseded by a structural one that the registry supplies. The replacement question is parked: EXPLORER-HCM alone carries a defensible responder estimate, and whether a single trial should be presented as this topic's result is a decision about what the page is for -- the same question BEMPEDOIC_ACID answered by saying k=1 on its card.
Three unrelated registered primaries. k = 3.
Authored on re-verification.
What each trial COUNTED, in its own registry record's words, before anything here was pooled. A sentence saying what HAPPENED is not a sentence saying what was COUNTED, and only the second one licenses a pool. Read from the registry on 2026-08-18. Follow the registration link to disagree with any row.
| Trial | Rank in its own trial | Registered outcome measure | Description, verbatim | Analysis set / window |
|---|---|---|---|---|
| EXPLORER-HCM NCT03470545 | PRIMARY -- primaryOutcomes[0] on this registration | Percentage of Participants Achieving A Clinical Response | A positive clinical response (value="YES") is defined as having achieved either an improvement of at least 1.5 mL/kg/min in peak oxygen consumption (pVO2) as determined by cardiopulmonary exercise testing (cpet) and a reduction of one or more class in New York Heart Association (NYHA) functional classification (e.g.I, ii, iii, or IV) -OR- an improvement of 3.0 mL/kg/min or more in pVO2 with no worsening in NYHA Functional Class. | 30 weeks. The stored counts 45 of 123 against 22 of 128 ARE this trial's responder counts. |
| VALOR-HCM NCT04349072 | PRIMARY -- primaryOutcomes[0] on this registration | Composite of Decision to Proceed With Septal Reduction Therapy (SRT) and SRT Guideline Eligible at Week 16 | Participants who decided to proceed with SRT or were eligible for SRT at week 16. Participants with missing assessments were classified as meeting the primary endpoint (did not improve). SRT eligibility using the New York Heart Association Functional Class (NYHA) and left ventricular outflow tract (lvot) assessments per the 2011 accf/AHA guideline clinical and hemodynamic criterion are below: * NYHA Class III or IV/ NYHA Class II with exertion-induced syncope/near syncope, and * Dynamic lvot gradient at rest or with provocation \>= 50 mmHg. NYHA Class II at week 16, the following rules will be applied: * NYHA Class II with history of exertional syncope/ syncope at baseline and at W16 is still NYHA Class II, they remain SRT eligible IF their maximal lvot gradient is ≥ 50mmHg * NYHA Class III/IV at baseline and at W16 has improved to Class II, they are no longer SRT eligible unless they have AE of exertional syncope or pre-syncope during the 16 weeks. | Week 16. This page holds NO counts for it. |
| Chinese phase 3 NCT05174416 | PRIMARY -- primaryOutcomes[0] on this registration | Change From Baseline to Week 30 in Valsalva Left Ventricular Outflow Tract (lvot) Peak Gradient | To compare the effect of a 30-week course of mavacamten with placebo on Valsalva lvot peak gradient as determined by Doppler echocardiography | Week 30. This page holds NO counts for it. |
In this section: Three unrelated registered primaries · Risk of bias · GOSH · Trial-sequential analysis · Meta-regression
⬇ SVG (vector) 1 KB
Only the vector format is offered for this figure, by choice: it is line art — discrete marks, glyphs and labels — which SVG reproduces exactly at any size, so a raster would add weight without adding fidelity. The build was able to rasterise; it was asked not to.
Not drawn, because there is nothing to draw it from.
⬇ SVG (vector) 1 KB ⬇ PNG 3500x540 80 KB
All raster formats were generated at build time from the same SVG as the graphic above (SHA-256, first 16 hex characters: dd33d4f986f7c7c5), at 600 dpi for a 6-inch print width, on a white ground. They are not screenshots of the page and do not change with the theme you are reading in.
Submission formats written to the figures directory, not embedded here because an uncompressed 600 dpi TIFF is tens of megabytes: EPS (vector, journal's first choice for line art) — gosh.eps, 2 KB; TIFF (uncompressed, 600 dpi -- journal fallback) — gosh.tiff, 5,537 KB.
Deliberately not drawn. Every subset meta-analysis of 3 trials is 7 points; a cloud that small cannot show the multimodality GOSH exists to reveal, and a reader would take the picture as evidence of its absence.
⬇ SVG (vector) 1 KB ⬇ PNG 3500x650 87 KB
All raster formats were generated at build time from the same SVG as the graphic above (SHA-256, first 16 hex characters: 25ed9800fdf56614), at 600 dpi for a 6-inch print width, on a white ground. They are not screenshots of the page and do not change with the theme you are reading in.
Submission formats written to the figures directory, not embedded here because an uncompressed 600 dpi TIFF is tens of megabytes: EPS (vector, journal's first choice for line art) — tsa.eps, 2 KB; TIFF (uncompressed, 600 dpi -- journal fallback) — tsa.tiff, 6,665 KB.
TSA boundaries depend entirely on a target information size that must be pre-specified. This review's protocol registers none, so any boundary drawn here would be a parameter chosen after seeing the data -- which is the practice TSA exists to protect against.
⬇ SVG (vector) 1 KB ⬇ PNG 3500x540 87 KB
All raster formats were generated at build time from the same SVG as the graphic above (SHA-256, first 16 hex characters: 2316b730fa24744e), at 600 dpi for a 6-inch print width, on a white ground. They are not screenshots of the page and do not change with the theme you are reading in.
Submission formats written to the figures directory, not embedded here because an uncompressed 600 dpi TIFF is tens of megabytes: EPS (vector, journal's first choice for line art) — bubble.eps, 2 KB; TIFF (uncompressed, 600 dpi -- journal fallback) — bubble.tiff, 5,537 KB.
The protocol pre-specifies no moderator, and at k = 3 a meta-regression would be fitted on 3 points. Not drawn rather than drawn with a caveat: a bubble plot invites reading a slope, and there is no slope here that any reader should read.
In this section: Summary of findings · Reproducibility artifact · Other recorded qualifications
| Outcome | k | Pooled effect | Certainty |
|---|---|---|---|
| Three unrelated registered primaries | 3 | not pooled | See comment12 |
| Canonical object | — |
|---|---|
| Registered at | — — |
| Schema | 2-authored-from-source |
| Object last updated | 2026-08-18T00:00Z |
| Source object SHA-256, first 16 hex characters | c3f1290eabd23edb |
| Page generated | 2026-08-28 07:28 UTC |
| Generator build | 59b484ca7. The standard this page was built to is NOT ESTABLISHED: this object carries no build_stamp, so the version above is the standard that exists now, not the one this page was built against. |
This page CANNOT be rebuilt from what is recorded here: no canonical object is recorded and no registered commit is recorded. Each figure on the Analysis tab downloads as an SVG carrying exactly the values shown.
Statements this review records about the limits of what it establishes, which are not shown elsewhere on this page. They are reproduced from the object verbatim and are not summarised.
| Components as the registry states them | a composite responder definition: (pVO2 improvement of at least 1.5 mL/kg/min and at least one NYHA class improvement) OR (pVO2 improvement of at least 3.0 mL/kg/min with no NYHA worsening). |
|---|---|
| Analysis set as the registry states it | 30 weeks. The stored counts 45 of 123 against 22 of 128 ARE this trial's responder counts. |
| Components as the registry states them | a composite of the decision to proceed with septal reduction therapy and being srt guideline eligible at week 16. That is a TREATMENT-DECISION endpoint, not a symptom, not a physiological measure and not a clinical event. |
| Components as the registry states them | Change from baseline to week 30 in valsalva left ventricular outflow tract peak gradient. A continuous haemodynamic measurement with no events. |
In this section: Summary
Question. Three trials, three unrelated registered primaries: a responder composite, a septal-reduction-therapy decision, and a continuous pressure gradient.
What was checked. ClinicalTrials.gov protocol records, read 2026-08-18
What was found. 3 registered trials:
| Registration | Trial |
|---|---|
| NCT03470545 | EXPLORER-HCM |
| NCT04349072 | VALOR-HCM |
| NCT05174416 | Chinese phase 3 |
Why no result is pooled. Three trials, three unrelated registered primaries. Verbatim: explorer-hcm registers a composite responder definition built from peak oxygen consumption and nyha class. Valor-hcm registers a 'Composite of Decision to Proceed With Septal Reduction Therapy (srt) and srt Guideline Eligible at Week 16' -- A treatment-decision endpoint, which measures what clinicians decided rather than what happened to patients.
Whether these trials study this subject. Checked against each registration's arm structure on 2026-08-25. 3 of 3 trials were confirmed: the drug is part of the randomised comparison.
What would change this. A pooled result becomes possible when trials reporting a shared, comparably measured outcome are available.
No pooled estimate, risk-of-bias assessment or certainty rating is published for this question, because there is no combined result for them to describe.
UNSTAMPED — unknown-version. This page carries no build_stamp, so the standard it was built to cannot be established. That is a statement about the record, not a claim that the page is below standard.
Every number on this page is projected from a single canonical object, and each measured cell names the source analysis it was read from. That is what is machine-checked. It does not establish that the underlying sources are right, only that this page faithfully reports them.