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A Study of Genetically Targeted Enzyme Replacement Therapy for Advanced Heart Failure

NCT01643330 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2016-03-24

No results posted yet for this study

Summary

The purpose of this trial is to assess whether MYDICAR can reduce the frequency and/or delay heart failure related hospitalizations in persons with advanced heart failure when added to their maximal and optimized therapy.

Conditions

  • Ischemic Cardiomyopathy
  • Non-ischemic Cardiomyopathy
  • Heart Failure
  • Cardiomyopathies

Interventions

GENETIC

AAV1/SERCA2a (MYDICAR)

Single intracoronary infusion 1 x 10\^13 DNase Resistant Particles (DRP) MYDICAR

GENETIC

Placebo

Single intracoronary infusion

Sponsors & Collaborators

  • Celladon Corporation

    lead INDUSTRY

Principal Investigators

  • Call 1-858-366-4288 · Celladon Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2015-02-28
Completion
2016-02-29

Countries

  • United States
  • Belgium
  • Denmark
  • Germany
  • Hungary
  • Israel
  • Netherlands
  • Poland
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01643330 on ClinicalTrials.gov