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Идёт набор NCT06551129

Real-world Patient Reported Outcomes Among Patients Treated With Camzyos

— Наблюдательное Obstructive Hypertrophic Cardiomyopathy

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Mavacamten.
Кому может быть актуально
Состояния в реестре: Obstructive Hypertrophic Cardiomyopathy. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Real-World Camzyos Patient Reported OutcoMes Through PAtient SurveyS in Hypertrophic CardioMyopathy (COMPASS-HCM): A Prospective Longitudinal Study

Обзор

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.

Вмешательства

  • Препарат Mavacamten
    As prescribed by treating physician

Первичные конечные точки

  • Participant Hypertrophic Cardiomyopathy symptoms as assessed by Hypertrophic Cardiomyopathy Symptom Questionnaire (HCMSQ v2,0 - 7-day recall version) [Срок оценки: Baseline and weeks 2, 4, 8, 12, 24, 30, 48, 60, 72, 84 and 96]
  • Participant physical limitation, symptom stability, symptom frequency, symptom burden, self-efficacy, QoL, and social limitations as assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ-23) [Срок оценки: Baseline and weeks 2, 4, 8, 12, 24, 30, 48, 60, 72, 84 and 96]
  • Participant mavacamten treatment status [Срок оценки: Weeks 2, 4, 8, 12, 24, 30, 48, 60, 72, 84 and 96]
  • Other pharmacological and surgical treatments for obstructive hypertrophic cardiomyopathy (HCM) [Срок оценки: Baseline and weeks 2, 4, 8, 12, 24, 30, 48, 60, 72, 84 and 96]
  • Participant symptom severity as assessed by self-assessed New York Heart Association (SA-NYHA) functional class [Срок оценки: Baseline and weeks 2, 4, 8, 12, 24, 30, 48, 60, 72, 84 and 96]
  • Participant change in symptom severity as assessed by Patient Global Impression of Change (PGI-C) [Срок оценки: Weeks 2, 4, 8, 12, 24, 30, 48, 72, and 96]
  • Participant septal reduction therapy [Срок оценки: Baseline and weeks 12, 30, 48 and 96]
  • Participant major injury or surgery since previous survey [Срок оценки: Weeks 2, 4, 8, 12, 24, 30, 48, 60, 72, 84 and 96]
  • Participant survey response on experience with CAMZYOS Risk Evaluation and Mitigation Strategy program (REMS) Program [Срок оценки: Baseline and weeks 4, 12, 30, 48, 72 and 96]
  • Participant medical history [Срок оценки: Baseline]

Критерии участия

Критерии включения

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

Критерии исключения

  • 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 transient ischemic attack 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 1 центр
  • Analysis Group Inc. — Boston

Идентификаторы

NCT: NCT06551129 · CV027-1002

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗