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Mavacamten for Hypertrophic Cardiomyopathy

Usf Health South Tampa Center For Advanced Healthcare, Tampa, FL
Hypertrophic CardiomyopathyMavacamten - Drug
Eligibility
18+
All Sexes

Study Summary

This trial is testing a new drug to treat heart problems in people with hypertrophic cardiomyopathy.

Eligible Conditions
  • Hypertrophic Cardiomyopathy

Treatment Effectiveness

Phase-Based Effectiveness

2 of 3
Phase 3
This is further along than 85% of similar trials

Similar Trials

1
Cohort 2
1
CardiolRx
1
NNC6019-0001

Study Objectives

2 Primary · 22 Secondary · Reporting Duration: Up to 124 Weeks

Up to 124 Weeks
Nesiritide
Concentration-response relationship between MYK-461 Ctrough (ng/mL) and cardiac troponin T (cTn-T)
Concentration-response relationship between MYK-461 Ctrough (ng/mL) and left ventricular ejection fraction (LVEF)
Concentration-response relationship between MYK-461 Ctrough (ng/mL) and ratio between early mitral inflow velocity and mitral annular early diastolic velocity (E/e')
Plasma
Time to CV death
Time to all-cause death
Cardiac Arrhythmia
Up to Week 52
Cardiomyopathies
Nesiritide
Change from baseline in cardiac troponin-T (cTn-T) to Week 52
Diastole
Diastole
Change from baseline in echocardiographic measures of diastolic function at Week 52: average medial E/e'
Diastole
Hypertrophic Cardiomyopathy
Change from baseline in peak exercise time to Week 52
Oxygen
Erythrocyte Indices
Change from baseline in ventilatory efficiency (VE/VCO2) slope to Week 52
Change from baseline to Week 52 in EQ-5D scores (visual analogue scale [VAS])
Change from baseline to Week 52 in EuroQol-5 Dimension (EQ-5D) scores (Index)
Proportion of participants with (1) pVO2 ≥ 1.5 milliliter per kilogram per minute (mL/kg/min) and NYHA improvement ≥ 1; or (2) pVO2 ≥ 3 mL/kg/min and NYHA no worsening, from baseline to Week 52
Proportion of participants with at least 1 class of New York Heart Association (NYHA) improvement from baseline to Week 52

Trial Safety

Phase-Based Safety

3 of 3
This is further along than 85% of similar trials

Similar Trials

2
Cohort 2
2
CardiolRx
2
NNC6019-0001

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2 Treatment Groups

Mavacamten
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

420 Total Participants · 2 Treatment Groups

Primary Treatment: Mavacamten · Has Placebo Group · Phase 3

Mavacamten
Drug
Experimental Group · 1 Intervention: Mavacamten · Intervention Types: Drug
Placebo
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mavacamten
2022
Completed Phase 1
~250

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 124 weeks

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,542 Previous Clinical Trials
4,019,236 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a heart condition called hypertrophic cardiomyopathy (HCM) which causes your heart muscle to thicken abnormally. This is diagnosed if your heart's left ventricular wall thickness is greater than or equal to 15 millimeters (mm) or greater than or equal to 13 mm if you have a family history of HCM, and there are no other known heart or systemic diseases causing the thickening. The diagnosis will be confirmed by a specialized laboratory.
Your heart's left ventricular outflow tract pressure gradient should be less than 30 mm Hg while at rest, and less than 50 mm Hg when undergoing certain tests to provoke a response from your heart.
You have heart problems that fall under Class II or III of the New York Heart Association (NYHA) classification.

Who else is applying?

What state do they live in?
Kentucky100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%
References

Frequently Asked Questions

Are new participants being added to this research project?

"Unfortunately, this particular clinical trial is not enrolling patients at the moment. The original posting was on October 31st, 2022 with the most recent update being on October 25th of the same year. Although there are no openings for this study, there are 236 other trials that have open recruitment periods." - Anonymous Online Contributor

Unverified Answer

In how many different medical clinics is this research study being conducted today?

"There are a total of 21 sites currently recruiting patients for this trial, which are based in cities including Grand Rapids, London and Kansas City. It would be most convenient to select the clinic nearest you to avoid any unnecessary travel." - Anonymous Online Contributor

Unverified Answer

When might Mavacamten be available to the public?

"Mavacamten's safety has been well-documented in Phase 3 trials, with efficacy seen in multiple rounds of testing. As such, it received a score of 3 from our team at Power." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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