Design of a Phase 2b Trial of Intracoronary Administration of AAV1/SERCA2a in Patients With Advanced Heart Failure. The CUPID 2 Trial (Calcium Up-Regulation by Percutaneous Administration of Gene Therapy in Cardiac Disease Phase 2b)

JACC: Heart Failure

Volumn 2, Issue 1, 2014, Pages 84-92

  Greenberg, Barry ^a   Yaroshinsky, Alex ^b   Zsebo, Krisztina M ^c   Butler, Javed ^d   Felker, G Michael ^e   Voors, Adriaan A ^f   Rudy, Jeffrey J ^c   Wagner, Kim ^c   Hajjar, Roger J ^g  

^a UNIVERSITY OF CALIFORNIA   (United States)

^b AY Statistical Consulting   (United States)

^c Celladon Corporation   (United States)

^d EMORY UNIVERSITY   (United States)

^e DUKE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^f UNIVERSITY MEDICAL CENTER GRONINGEN   (Netherlands)

^g MOUNT SINAI SCHOOL OF MEDICINE   (United States)

Author keywords

Clinical trial; Heart failure; Joint frailty model; Recurrent events; SERCA2a

Indexed keywords

ADENOVIRUS VECTOR; AMINO TERMINAL PRO BRAIN NATRIURETIC PEPTIDE; CAPSID PROTEIN; PLACEBO; SARCOPLASMIC RETICULUM CALCIUM TRANSPORTING ADENOSINE TRIPHOSPHATASE; SARCOPLASMIC RETICULUM CALCIUM TRANSPORTING ADENOSINE TRIPHOSPHATASE 2A; UNCLASSIFIED DRUG; GENE THERAPY AGENT; PROTEIN SERCA2A; ATP2A2 PROTEIN, HUMAN; CALCIUM; RECOMBINANT PROTEIN;

ADULT; AGED; ARTICLE; CALCIUM CELL LEVEL; CALCIUM TRANSPORT; CARDIOVASCULAR MORTALITY; CONTROLLED STUDY; DIASTOLIC BLOOD PRESSURE; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG TOLERABILITY; FEMALE; HEART ATRIUM FIBRILLATION; HEART EJECTION FRACTION; HEART FAILURE; HIGH RISK PATIENT; HOSPITALIZATION; HUMAN; INCIDENCE; INTENTION TO TREAT ANALYSIS; INTRACORONARY DRUG ADMINISTRATION; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SENSITIVITY ANALYSIS; SYSTOLIC BLOOD PRESSURE; TREATMENT OUTCOME; UPREGULATION; VIRAL GENE THERAPY; CARDIOVASCULAR GENE THERAPY; DRUG EFFECT; DRUG SAFETY; GENE; HUMAN ADENOVIRUS 1; SERCA2A GENE; STUDY DESIGN; VIRAL GENE DELIVERY SYSTEM; ADENOVIRIDAE; CLINICAL TRIAL; GENE THERAPY; GENE TRANSFER; GENE VECTOR; GENETICS; INTRADERMAL DRUG ADMINISTRATION; INTRALESIONAL DRUG ADMINISTRATION; METABOLISM; PROCEDURES; RECURRENT DISEASE;

ADENOVIRIDAE; ADMINISTRATION, CUTANEOUS; CALCIUM; DOUBLE-BLIND METHOD; GENE TRANSFER TECHNIQUES; GENETIC THERAPY; GENETIC VECTORS; HEART FAILURE; HUMANS; INFUSIONS, INTRALESIONAL; RECOMBINANT PROTEINS; RECURRENCE; SARCOPLASMIC RETICULUM CALCIUM-TRANSPORTING ATPASES; TREATMENT OUTCOME; UP-REGULATION;

EID: 84893018080     PISSN: 22131779     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jchf.2013.09.008     Document Type: Article

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