Share Icon Health Study Area: Cardiovascular Disease Chevron Icon Health Study Area: Genitourinary For Patients Health Study Area: Lung Cancer Page Icon Phone Icon For Caregivers Health Study Area: AutoImmune Disease Health Study Area: Melanoma Location Icon Print YouTube Icon For Parents Health Study Area: Lung Cancer Print Created with Sketch. Help Icon Green Check Icon Search Icon Instagram Created with sketchtool. Direction Arrow Icon Error Icon For Parents Health Study Area: Blood Cancer Help Icon Health Study Area: NASH Gender Both Bookmark Icon Health Study Area: Melanoma Created with Sketch. Glossary Print Health Study Area: Blood Cancer Health Study Area: Genitourinary Health Study Area: Gastrointestinal Cancer Mobile Menu Icon Created with Sketch. Health Study Area: Cardiovascular Disease Health Study Area: Women's Cancer Communities Map Icon Created with Sketch. For Caregivers Health Study Area: Fibrosis Health Study Area: AutoImmune Disease FAQs Health Study Area: Head and Neck Cancer Created with Sketch. For Clinicians Chevron Right Icon Gender Female Health Study Area: Breast Cancer Direction Arrow Icon Gender Both Right Arrow Icon LinkedIn Icon Green Check Icon Gender Male Health Study Area: Fibrosis For Patients Twitter Icon Email Icon Facebook Icon Health Study Area: Gastrointestinal Cancer Health Study Area: Head and Neck Cancer For Clinicians External Link Icon
Szukaj Study Connect

Active, Not Recruiting

A Study to Evaluate Mavacamten in Adults With Symptomatic Obstructive HCM Who Are Eligible for Septal Reduction Therapy - CV027-006

Zaktualizowano: 17 maj, 2023   |   ClinicalTrials.gov

Wydruk podsumowania

BIERZESZ POD UWAGĘ TO BADANIE?
Wydrukuj tę stronę i przewodnik po badaniu, aby pomóc sobie w rozmowie z lekarzem.
Skorzystaj z Przewodnika po badaniu, aby dowiedzieć się o procesie badań klinicznych. Zapoznaj się z kluczowymi czynnikami, które należy wziąć pod uwagę przed podjęciem decyzji i zanotuj pytania, aby zadać je personelowi medycznemu.

Szczegóły badania

  • Phase 3

    Etap

  • Płeć

  • 18+

    Zakres wieku

  • Active, Not Recruiting

Opcje leczenia

Grupy badania
PRZYPISANA INTERWENCJA
Experimental: Drug: Mavacamten
Drug: Mavacamten
Placebo Comparator: Drug: Placebo
Drug: Placebo

Kluczowe kryteria kwalifikacyjne

Key Inclusion Criteria: - At least 18 years old at screening and body weight > 45 kg at screening - Diagnosed with oHCM consistent with current ACCF/AHA 2011 and/or ESC 2014 guidelines and meet their recommendations for invasive therapies - Referred or under active consideration within the past 12 months for SRT procedure and willing to have SRT procedure - Has documented left ventricular ejection fraction (LVEF) ≥ 60% at Screening - Has documented oxygen saturation at rest ≥ 90% at Screening Key Exclusion Criteria: - Persistent or permanent atrial fibrillation and subject not on anticoagulation for ≥ 4 weeks prior to screening and/or not adequately rate controlled ≤ 6 months prior to screening - Previously treated with invasive septal reduction (surgical myectomy or percutaneous alcohol septal ablation [ASA]) - For individuals on beta blockers, calcium channel blockers, or disopyramide, any dose adjustment of these medications < 14 days prior to screening or an anticipated change in regimen during the first 16 weeks of the study - Any medical condition that precludes upright exercise stress testing - Paroxysmal, intermittent atrial fibrillation with atrial fibrillation present at screening - Prior treatment with cardiotoxic agents, such as doxorubicin or similar - Has a history or evidence of any other clinically significant disorder, condition, or disease that would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion