Mavacamten
DrugSpecified dose on specified days
Active, Not Recruiting
NCT Number: NCT06112743
A Study to Evaluate Mavacamten Impact on Myocardial Structure in Participants With Symptomatic Obstructive Hypertrophic Cardiomyopathy
The purpose of this study is to evaluate the mavacamten impact on myocardial structure with cardiac magnetic resonance imaging (CMR) in adult participants with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) [New York Heart Association (NYHA) Functional Class II or III].
Active, Not Recruiting
This study is active but is not currently recruiting participants.
Key information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 4
Primary location
Local Institution - 0075, Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Loading trial locations.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Diagnosed with obstructive hypertrophic cardiomyopathy (oHCM), in accordance with current American College of Cardiology Foundation/American Heart Association and European Society of Cardiology guidelines as below:.
- Left ventricular outflow tract (LVOT) peak gradient ≥ 30 mmHg and ≥ 50 mmHg after Valsalva or after exercise.
- Left ventricular ejection fraction (LVEF) ≥ 55% at rest.
- New York Heart Association (NYHA) functional class II or III symptoms.
Exclusion criteria
- A known infiltrative or storage disorder causing cardiac hypertrophy that mimics oHCM.
- Documented obstructive coronary artery disease or history of myocardial infarction.
- A history of resuscitated sudden cardiac arrest or life-threatening ventricular arrhythmia within 6 months prior to screening.
- An implantable cardioverter defibrillator (ICD) or pacemaker, or another contraindication for cardiac magnetic resonance imaging (CMR).
- Other protocol-defined inclusion/exclusion criteria apply.
Treatment and study plan
Primary outcomes
-
Composite of maximum left atrial volume index (LAVI) and left ventricular mass index (LVMI) at Week 48
Time frame: At week 48
Participants achieving both of the following criteria at Week 48 cardiac magnetic resonance imaging (CMR) assessment:
- A decrease of at least 5 mL/m2 in maximum LAVI from baseline
- A decrease of at least 5 g/m2 in LVMI from baseline
Secondary outcomes
-
Proportion of participants who had at least 1 class of improvement from baseline in New York Heart Association (NYHA) class at Week 48
Time frame: At week 48
-
Change from baseline in maximum left atrial volume index (LAVI) at Week 48
Time frame: At week 48
-
Change from baseline in left ventricular mass index (LVMI) at Week 48
Time frame: At week 48
-
Incidence of major adverse cardiac events (MACE)
Time frame: Up to 48 weeks
-
Incidence of MACE-expanded events
Time frame: Up to 48 weeks
-
All-cause mortality
Time frame: Up to 48 weeks
-
Incidence of heart failure (HF) events
Time frame: Up to 48 weeks
-
Incidence of HF events with systolic dysfunction
Time frame: Up to 48 weeks
-
Incidence of atrial fibrillation (AF)/atrial flutter
Time frame: Up to 48 weeks
-
Incidence of cardiovascular (CV) mortality
Time frame: Up to 48 weeks
-
Incidence of ventricular tachyarrhythmias
Time frame: Up to 48 weeks
-
Incidence of nonvasovagal syncope and seizures
Time frame: Up to 48 weeks
-
Incidence of treatment emergent adverse events (TEAEs)
Time frame: Up to 48 weeks
-
Severity of TEAEs
Time frame: Up to 48 weeks
-
Incidence of treatment emergent serious adverse events (SAEs)
Time frame: Up to 48 weeks
-
TEAEs leading to discontinuation from study intervention
Time frame: Up to 48 weeks
-
TEAEs leading to laboratory abnormalities
Time frame: Up to 48 weeks
Sponsors and collaborators
Lead sponsor
Bristol-Myers Squibb
Industry
Registry information
Official study title
MEMENTO - A Phase 4, Single-arm, Open-label Clinical Study to Evaluate Mavacamten in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy to Assess the Impact on Myocardial Structure With Cardiac Magnetic Resonance Imaging (CMR)
Acronym: MEMENTO
Important dates
- Study start
- 2024
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Nov 1, 2023
- Registry last updated
- Sep 22, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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