Exploratory Study of Danicamtiv in Patients With Primary Dilated Cardiomyopathy (DCM) Due to Genetic Variants

Título: 
Exploratory Study of Danicamtiv in Patients With Primary Dilated Cardiomyopathy (DCM) Due to Genetic Variants
Estado de reclutamiento: 
Estado se actualizó más recientemente: 
May 11, 2021
Propósito de estudio: 

The purpose of this Phase 2a study is to establish safety and preliminary efficacy of treatment with danicamtiv in patients with primary dilated cardiomyopathy (DCM) due to MYH7 or TTN variants .

Intervención / tratamiento: 
Drug: danicamtiv
Fase: 
Descripción del estudio: 

Primary Familial Dilated Cardiomyopathy

Tipo de estudio: 
Título oficial: 
An Open-Label, Exploratory Study of the Safety and Preliminary Efficacy of Danicamtiv in Stable Ambulatory Patients With Primary Dilated Cardiomyopathy Due to Either MYH7 or TTN Variants
Fecha de inicio del estudio: 
August 19, 2020
Fecha de finalización del estudio: 
September 2023
Objetivo(s) principal(es): 

Frequency and severity of treatment-emergent adverse events and serious adverse events. [ Time Frame: Up to 22 days ]

Objetivo(s) secundario(s): 

N/A

Elegibilidad: 

Ages Eligible for Study:      18 Years to 80 Years   (Adult, Older Adult)

Sexes Eligible for Study:      All

Accepts Healthy Volunteers:      No

Criterios de inclusión: 
  • Has stable primary dilated cardiomyopathy due to either MYH7 or TTN variant
  • Has adequate acoustic windows for echocardiography
  • Maximum of 3 family members with same variant can be enrolled
Criterio de exclusión: 
  • Any significant structural cardiac abnormalities on Screening transthoracic echo(s)
  • A pathogenic variant implicated in DCM of another gene other than MYH7 or TTN
  • Routinely scheduled outpatient intravenous (IV) infusions for heart failure (e.g., inotropes, vasodilators [e.g., nesiritide], diuretics), or routinely scheduled ultrafiltration
  • Presence of protocol specified laboratory abnormalities at Screening
Sitio(s) de estudio / Ubicacion(es): 

United States, California

University of California, San Diego Medical CenterRecruiting

La Jolla, California, United States, 92037

Contact: Maylene Alegre    858-246-2511    malegre@health.ucsd.edu   

United States, District of Columbia

MedStar Georgetown University Hospital Not yet recruiting

Washington, District of Columbia, United States, 20007

Contact: Michelle Deville       michelle.deville@medstar.net   

United States, Florida

University of South FloridaNot yet recruiting

Tampa, Florida, United States, 33606

Contact: Nhi Tran       nntran@health.usf.edu   

United States, Illinois

Medical Center of Northwestern UniversityNot yet recruiting

Chicago, Illinois, United States, 60611

Contact: Hamorabi Mkrdichian       hmkrdich@nm.org   

United States, Massachusetts

Brigham and Women's HospitalRecruiting

Boston, Massachusetts, United States, 02115

Contact: Mary Sheehan    617-732-6237    msheehan1@bwh.harvard.edu   

United States, Minnesota

Mayo Clinic - RochesterNot yet recruiting

Rochester, Minnesota, United States, 55905

Contact: Megan Peterson       peterson.megan3@mayo.edu   

United States, Ohio

Cleveland ClinicNot yet recruiting

Cleveland, Ohio, United States, 44195

Ohio State University Wexner Medical CenterNot yet recruiting

Columbus, Ohio, United States, 43210

United States, Pennsylvania

University of Pennsylvania - Heart and Vascular CenterNot yet recruiting

Philadelphia, Pennsylvania, United States, 19104

Contact: Jessica Kim       jessica.kim4@pennmedicine.upenn.edu   

United States, South Carolina

Medical University of South CarolinaRecruiting

Charleston, South Carolina, United States, 29425

Contact: Ellie Cutright    843-792-2944    cutrighe@musc.edu   

United States, Tennessee

The Stern Cardiovascular CenterRecruiting

Germantown, Tennessee, United States, 38138

Contact: Carye Jackman    901-448-5750    cjackman@uthsc.edu   

Germany

Universitaetsklinikum HeidelbergRecruiting

Heidelberg, Germany, 69126

Contact: Sonja Tran       Sonja.Tran@med.uniheidelberg.de   

Universitaetsklinikum Würzburg Not yet recruiting

Würzburg, Germany, 97080

Contact: Peer Papior       papior_p@ukw.de   

Spain

Hospital Universitario Puerta de Hierro Majadahonda Recruiting

Majadahonda, Madrid, Spain, 28222

Contact: Ariadna Gonzalez Segovia    +34 911 91 7297    ariadna.segovia@salud.madrid.org   

Hospital Clinico Universitario Virgen de la Arrixaca Recruiting

El Palmar, Murcia, Spain, 28036

Contact: David Lopez    +34 679 22 2025    dalopezcu@gmail.com   

Complejo Hospitalario Universitario A Coruña Not yet recruiting

A Coruña, Spain, 15006

United Kingdom

St. Bartholomew's Hospital Not yet recruiting

London, United Kingdom, EC1M 6BQ

Contact: Hakam Abbass    +44 020 3765 8635    hakam.abbass@nhs.net   

Royal Brompton Hospital Recruiting

London, United Kingdom, UB9 6JH

Contact: Maria Teresa Pfyl    +44 020 7352 8121 ext 82823    m.pfyl@rbht.nhs.uk   

Patrocinadores y Colaboradores: 

MyoKardia, Inc.

Investigador(es) principal(es): 

N/A

Para obtener más información, por favor comuníquese con el Coordinador del estudio: 

Contact:  

Email: 

Phone: 

ID de ClinicalTrials.gov: 
NCT04572893