Efficacy and Safety Study of Genetically Targeted Enzyme Replacement Therapy for Advanced Heart Failure
Public ClinicalTrials.gov record NCT00454818. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1/2 Trial of Intracoronary Administration of MYDICAR® (AAV1/SERCA2a) in Subjects With Heart Failure in Two Stages (Open-Label, Sequential Dose-Escalation Cohorts and Randomized, Double-Blind, Placebo-Controlled, Parallel Cohorts)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The study is divided into 2 parts. In the first part, the safety of the gene transfer agent MYDICAR® will be evaluated. In the second part, the ability of MYDICAR® to improve heart function will be studied.
Study identification
- NCT ID
- NCT00454818
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 51 participants
Conditions and interventions
Conditions
Interventions
- MYDICAR Phase 1 (Open-label, Serial Dose-Escalation Study) Genetic
- Placebo Infusion Procedure
- MYDICAR Phase 2 (Placebo-controlled, Randomized Study) Genetic
Genetic · Procedure
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 2007 (Type not available)
- Primary completion
- Aug 2010 (Actual)
- Completion
- Aug 2012 (Actual)
- Last update posted
- Aug 20, 2014
2007 – 2012
United States locations
- U.S. sites
- 22
- U.S. states
- 14
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of California at San Diego Medical Center | San Diego | California | 92103 | — |
| San Diego Cardiac Center | San Diego | California | 92123 | — |
| Shands Hospital at University of Florida | Gainesville | Florida | 32608 | — |
| Northwestern University | Chicago | Illinois | 60611 | — |
| University of Chicago Medical Center | Chicago | Illinois | 60637 | — |
| Mid America Heart Institute, Saint Luke's Hospital | Kansas City | Missouri | 64111 | — |
| St. Louis University Hospital | St Louis | Missouri | 63110 | — |
| University of Medicine and Dentistry of New Jersey | Newark | New Jersey | 07101 | — |
| Mount Sinai Medical Center | New York | New York | 10029 | — |
| Columbia University Hospital | New York | New York | 10032 | — |
| Wake Forest University | Winston-Salem | North Carolina | 27157 | — |
| University of Cincinnati | Cincinnati | Ohio | 45267 | — |
| MetroHealth Medical Center | Cleveland | Ohio | 44109 | — |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | — |
| Oregon Health and Science University | Portland | Oregon | 97239 | — |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| University of Pittsburgh Medical Center, Presbyterian-Shadyside Hospital | Pittsburgh | Pennsylvania | 15213 | — |
| Tennessee Center for Clinical Trials & Harton Regional Medical Center | Tullahoma | Tennessee | 37388 | — |
| Cardiopulmonary Research Science and Technology Institute, Medical City Dallas Hospital | Dallas | Texas | 75230 | — |
| Methodist Hospital | Houston | Texas | 77030 | — |
| Intermountain Medical Center | Murray | Utah | 84157 | — |
| University of Wisconsin | Madison | Wisconsin | 53792 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00454818, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 20, 2014 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00454818 live on ClinicalTrials.gov.