Phase
Condition
Heart Disease
Circulation Disorders
Congestive Heart Failure
Treatment
ARRY-371797 (PF-07265803)
Placebo
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Selected Key Inclusion Criteria:
- Patients with symptomatic lamin A/C protein (LMNA)-related cardiomyopathy ClassII/III/ or Class IV defined as:
- Gene positive for a pathogenic, likely pathogenic, or VUS mutation in the LMNA gene asdetermined by an accredited clinical laboratory.
- Evidence of cardiac impairment in LVEF <= 50%
- Patient will have an implantable cardioverter defibrillator/cardiac resynchronizationtherapy defibrillator (ICD/CRT-D). ICD implanted at least 4 weeks prior to initiationof study treatment or CRT-D initiated at least 6 months prior to initiation of studytreatment and defibrillation function activated at least 4 weeks prior to initiationof study treatment.
- Class II/III patients must have objective functional impairment evidenced by areduction in 6-minute walk test (6MWT); a. Screening: 6MWT distance >100 m but ≤450 m,AND b. Day -1 visit: 6MWT distance >100 m but ≤485 m, AND c. Baseline visit (Day 1): 6MWT distance >100 m but ≤485
- Class II/III patients must be stable for at least 3 months
- Stable medical and/or device therapy consistent with regional American HeartAssociation (AHA) / American College of Cardiology (ACC) or European Society ofCardiology (ESC) guidelines at the investigator discretion, without change in heartfailure drug(s) dose in the past 1 month.
- Patients must meet acceptable hematology, hepatic and renal laboratory values within 35 days prior to Day 1 as specified in the protocol.
Exclusion
Selected Key Exclusion Criteria:
- Presence of other form(s) of cardiomyopathy contributing to HF (eg, inflammatory orinfiltrative cardiomyopathy), clinically significant cardiac anatomic abnormality (eg,LV aneurysm), clinically significant coronary artery disease (eg, coronaryrevascularization, exercise induced angina) or uncorrected, hemodynamicallysignificant (ie, moderate-severe) primary structural valvular disease not due to HF,per investigator judgment.
- Currently receiving intermittent or continuous IV inotrope infusion, or presence of aventricular assist device, or history of prior heart transplantation. Participantslisted for cardiac transplantation may be enrolled provided transplantation is notlikely to occur in the next 6 months.
- Myocardial infarction, cardiac surgical procedures (other than for pacemaker/ICD/CRT-Dimplantation or replacement), acute coronary syndrome, serious systemic infection withevidence of septicemia, or any major surgical procedure requiring general anesthesiawithin 3 months prior to screening.
- Currently receiving or deemed at high risk of requiring chronic renal replacementtherapy (eg, hemodialysis or peritoneal dialysis) within 6 months.
- Initiation of CRT within 6 months prior to screening.
- Treatment with any investigational agent(s) for HF within 35 days prior to Day 1.
- Malignancy that is active or has been diagnosed within 3 years prior to screening,except surgically curatively resected in situ malignancies or surgically cured earlybreast cancer, prostate cancer, skin cancer (basal cell carcinoma, squamous cellcarcinoma), thyroid cancer, or cervical cancer, or, with prior review by the medicalmonitor, other early stage surgically curatively resected malignancies with less thana 20% expected 2 year recurrence rate.
- Non-cardiac condition that limits lifespan to < 1 year.
- Serum positive for hepatitis B surface antigen, viremic hepatitis C, or humanimmunodeficiency virus (HIV) at screening.
Study Design
Connect with a study center
Fundacion Favaloro para la Docencia e Investigacion Medica
Buenos Aires, Ciudad Autónoma DE Buenos Aires C1093AAS
ArgentinaSite Not Available
Hospital Provincial Del Centenario
Rosario, Santa FE S2000KDS
ArgentinaSite Not Available
Instituto CAICI
Rosario, Santa FE S2000 PBJ
ArgentinaSite Not Available
Hospital Británico de Buenos Aires
Buenos Aires, C1280AEB
ArgentinaSite Not Available
Hospital Provincial Dr Jose Maria Cullen
Santa Fe, S3000EOZ
ArgentinaSite Not Available
Onze-Lieve-Vrouwziekenhuis
Aalst, Oost-vlaanderen 9300
BelgiumSite Not Available
UZ Leuven
Leuven, 3000
BelgiumSite Not Available
St. Paul's Hospital
Vancouver, British Columbia V6Z 1Y6
CanadaSite Not Available
NSHA QEII Health Sciences Halifax Infirmary
Halifax, Nova Scotia B3H 3A7
CanadaSite Not Available
Nova Scotia Health Authority (Capital District Health Authority)
Halifax, Nova Scotia B3H 1V7
CanadaSite Not Available
University of Ottawa Heart Institute
Ottawa, Ontario K1Y 4W7
CanadaSite Not Available
Kawartha Cardiology Clinical Trials
Peterborough, Ontario K9J 0B2
CanadaSite Not Available
Clinical Laboratories of Montreal Heart Institute
Montreal, Quebec H1T 1C8
CanadaSite Not Available
Pfizer Investigational Site
Montréal, Quebec H1T 1C8
CanadaSite Not Available
Centre Intégré Universitaire de santé et de services sociaux de l'Estrie Centre hospitalier
Sherbrooke, Quebec J1G 2E8
CanadaSite Not Available
Ospedale Di Cattinara
Trieste, Friuli-venezia Giulia 34149
ItalySite Not Available
Azienda Ospedaliera Sant'Andrea
Roma, Lazio 00189
ItalySite Not Available
Fondazione IRCCS Policlinico San Matteo di Pavia
Pavia, PV 27100
ItalySite Not Available
Ospedale Santa Maria Della Misericordia Perugia
Perugia - Località S. Andrea Delle Fratte, Perugia 6132
ItalySite Not Available
Azienda Ospedaliera Universitaria Careggi
Firenze, Toscana 50134
ItalySite Not Available
Lacopo Olivotto, Azienda Ospedaliera Universitaria Careggi
Florence, Tuscany 50134
ItalySite Not Available
A.O.U. di Perugia Ospedale Santa Maria della Misericordia
Perugia, Umbria 06156
ItalySite Not Available
AO Ospedale Policlinico Consorziale di Bari
Bari, 70124
ItalySite Not Available
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
Bari, 70124
ItalySite Not Available
Azienda Ospedaliera Spedali Civili di Brescia
Brescia, 25123
ItalySite Not Available
IRCCS Pavia - Istituti Clinici Scientifici Maugeri Spa ? Società Benefit
Pavia, 27100
ItalySite Not Available
A.O.U. di Perugia Ospedale Santa Maria Della Misericordia
Perugia, 06132
ItalySite Not Available
Presidio Ospedaliero Madonna del Soccorso
San Benedetto del Tronto, 63074
ItalySite Not Available
Hospital Boutique Riobamba
Ciudad de Mexico, Distrito Federal 07300
MexicoSite Not Available
Cardiolink Clin Trials S.C.
Monterrey, Nuevo LEÓN 64060
MexicoSite Not Available
Christus Muguerza Hospital Alta Especialidad
Monterrey, Nuevo LEÓN 64060
MexicoSite Not Available
Fundación de Atención e Investigación Médica Lindavista S.C.
Ciudad de México, 07300
MexicoSite Not Available
Amsterdam UMC, Location Academic Medical Center
Amsterdam, Noord-holland 1105 AZ
NetherlandsSite Not Available
Sykehuset Innlandet HF Hamar
Hamar, 2318
NorwaySite Not Available
Oslo University Hospital, Rikshospitalet
Oslo, 0424
NorwaySite Not Available
Hospital Universitario A Coruña
A Coruña, A Coruna 15006
SpainSite Not Available
Centro de Farmacovigilancia de Galicia
Santiago de Compostela, A Coruña 15781
SpainSite Not Available
Pfizer Investigational Site
Badalona, Cataluña 8036
SpainSite Not Available
Hospital Universitario Puerta de Hierro de Majadahonda
Majadahonda, Madrid 28222
SpainSite Not Available
Hospital Universitario Virgen de la Arrixaca
El Palmar, Murcia 30120
SpainSite Not Available
Complejo Hospitalario Universitario de Vigo - H. Alvaro Cunqueiro
Vigo, Pontevedra 36312
SpainSite Not Available
Complexo Hospitalario Universitario A Coruña
A Coruna, 15006
SpainSite Not Available
Hospital Clinic de Barcelona
Barcelona, 08036
SpainSite Not Available
Hospital Universitario Vall d'Hebrón - PPDS
Barcelona, 08035
SpainSite Not Available
Hospital General Universitario Reina Sofia
Cordoba, 14004
SpainSite Not Available
C.H. Regional Reina Sofia - PPDS
Córdoba, 14004
SpainSite Not Available
Hospital General Universitario Gregorio Maranon
Madrid, 28007
SpainSite Not Available
Hospital Universitario Puerta de Hierro - Majadahonda
Majadahonda, 28222
SpainSite Not Available
Hospital Universitario Son Llatzer
Palma de Mallorca, 07198
SpainSite Not Available
Queen Elizabeth University Hospital - PPDS
Glasgow, Glasgow CITY G51 4TF
United KingdomSite Not Available
Royal Brompton Hospital
London, SW3 6NP
United KingdomSite Not Available
St Bartholomew's Hospital
London, EC1A 7BE
United KingdomSite Not Available
Cardiovascular Clinical Trials Unit
Birmingham, Alabama 35294
United StatesSite Not Available
IDS Pharmacy at UAB Hospital
Birmingham, Alabama 35249
United StatesSite Not Available
University of Alabama at Birmingham Hospital
Birmingham, Alabama 35233
United StatesSite Not Available
University of Alabama at Birmingham the Kirklin Clinic
Birmingham, Alabama 35233
United StatesSite Not Available
CB Flock Research Corporation
Mobile, Alabama 36608
United StatesSite Not Available
Chandler Regional Medical Center
Chandler, Arizona 85224
United StatesSite Not Available
Valley Heart Rhythm Specialists, PLLC
Chandler, Arizona 85224
United StatesSite Not Available
Cardiovascular Research Clinic
Gilbert, Arizona 85297-0425
United StatesSite Not Available
Cardiovascular and Stem Cell Consultants
Gilbert, Arizona 85297-0425
United StatesSite Not Available
Dignity Health, Mercy Gilbert Medical Center
Gilbert, Arizona 85297-0425
United StatesSite Not Available
Mercy Gilbert Medical Center
Gilbert, Arizona 85297
United StatesSite Not Available
Banner - Banner University Medical Center South
Tucson, Arizona 85713
United StatesSite Not Available
Banner - University Medical Center Tucson
Tucson, Arizona 85719
United StatesSite Not Available
Banner University Medical Center Tuscon
Tucson, Arizona 85724
United StatesSite Not Available
Banner University Medicine North
Tucson, Arizona 85719
United StatesSite Not Available
Children's Clinic
Tucson, Arizona 85712
United StatesSite Not Available
University of Arizona Sarver Heart Center
Tucson, Arizona 85724
United StatesSite Not Available
Ahmanson Cardiomyopathy Center Cardiovascular Genetics
Los Angeles, California 90095
United StatesSite Not Available
Clinical and Translational Research Unit (CTRU)
Palo Alto, California 94304
United StatesSite Not Available
Stanford Hospital and Clinics
Stanford, California 94305
United StatesSite Not Available
University of Colorado Academic Offices Building
Aurora, Colorado 80045
United StatesSite Not Available
University of Colorado Clinical and Translational Research Center
Aurora, Colorado 80045
United StatesSite Not Available
University of Colorado Hospital
Aurora, Colorado 80045
United StatesSite Not Available
Azienda Sanitaria Universitaria lntegrata di Trieste
Groton, Connecticut 06340
United StatesSite Not Available
Medstar Washington Hospital Center
Washington, District of Columbia 20010
United StatesSite Not Available
Innovative Research of West Florida
Clearwater, Florida 33756
United StatesSite Not Available
Sunrise Clinical Trials
Fort Lauderdale, Florida 33311
United StatesSite Not Available
Innovative Research of West Florida
Largo, Florida 33770
United StatesSite Not Available
Florida Cardiovascular Institute PA
Tampa, Florida 33609
United StatesSite Not Available
USF Health
Tampa, Florida 33606
United StatesSite Not Available
University of South Florida
Tampa, Florida 33606-3601
United StatesSite Not Available
Centers for Heart Failure Therapy
Atlanta, Georgia 30322
United StatesSite Not Available
Emory University Hospital
Atlanta, Georgia 30322
United StatesSite Not Available
Columbus Cardiology Associates Research - Centricity Research - HyperCore - PPDS
Columbus, Georgia 31904-6877
United StatesSite Not Available
Columbus Cardiology Associates Research - IACT - HyperCore - PPDS
Columbus, Georgia 31904-6877
United StatesSite Not Available
Columbus Regional Research Institute
Columbus, Georgia 31904
United StatesSite Not Available
Columbus Regional Research Institute at Talbotton - Centricity Research - HyperCore - PPDS
Columbus, Georgia 31904-8946
United StatesSite Not Available
Saint Luke's Idaho Cardiology Associates
Boise, Idaho 83712-6246
United StatesSite Not Available
St Luke's Idaho Cardiology Associates -Meridian
Meridian, Idaho 83642
United StatesSite Not Available
Brigham and Women's Hospital
Boston, Massachusetts 02115
United StatesSite Not Available
MyMichigan Medical Center Midland
Midland, Michigan 48670
United StatesSite Not Available
Washington University Center For Advanced Medicine
Saint Louis, Missouri 63110
United StatesSite Not Available
Washington University Center for Outpatient Health
Saint Louis, Missouri 63110
United StatesSite Not Available
Washington University School of Medicine
Saint Louis, Missouri 63110
United StatesSite Not Available
Newark Beth Israel Medical Center
Newark, New Jersey 07112
United StatesSite Not Available
Rutgers New Jersey Medical School - Doctors Office Center
Newark, New Jersey 07103
United StatesSite Not Available
Columbia University Irving Medical Center
New York, New York 10032
United StatesSite Not Available
Columbia University/Presbyterian Hospital - Vivian & Seymour Milstein Family Heart Center
New York, New York 10032
United StatesSite Not Available
NYU School of Medicine / NYU Langone Health
New York, New York 10016
United StatesSite Not Available
The Cleveland Clinic Foundation
Cleveland, Ohio 44195
United StatesSite Not Available
Ohio State University Wexner Medical Center
Columbus, Ohio 43210
United StatesSite Not Available
OHSU Research Pharmacy Services
Portland, Oregon 97239
United StatesSite Not Available
University of Pennsylvania Hospital
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
Medical University of South Carolina - PPDS
Charleston, South Carolina 29425-8911
United StatesSite Not Available
Stern Cardiovascular Foundation Inc
Germantown, Tennessee 38138
United StatesSite Not Available
Vanderbilt University Medical Center
Nashville, Tennessee 37232
United StatesSite Not Available
Tennessee Center for Clinical Trials
Tullahoma, Tennessee 37388
United StatesSite Not Available
Baylor Annette C and Harold C Simmons Transplant Institute
Dallas, Texas 75246
United StatesSite Not Available
Baylor Scott and White Heart and Vascular Hospital
Dallas, Texas 75226
United StatesSite Not Available
Texas Heart Institute
Houston, Texas 77030
United StatesSite Not Available
Baylor Scott and White Research Institute
Temple, Texas 76508
United StatesSite Not Available
Intermountain Medical Center
Murray, Utah 84107
United StatesSite Not Available
University of Washington Medical Center
Seattle, Washington 98195
United StatesSite Not Available
Meriter Hospital
Madison, Wisconsin 53713
United StatesSite Not Available
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