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| Name | Class |
|---|---|
| Brigham and Women's Hospital | OTHER |
| University of Maryland | OTHER |
| Yale University | OTHER |
| Washington University School of Medicine |
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This study is looking at differences in metabolism and functional imaging between pulmonary hypertension subjects with normal right ventricular function and persistent right ventricular dysfunction.
We will measure right ventricular metabolic and structural changes using serial 11C-acetate and 18F-FDG PET/CT and cardiac MRI as response to treatment with ranolazine. Subjects undergo imaging procedures at week 0 and week 26 (optional for normal function patients). This is a companion imaging trial for patients who are eligible for the treatment trial entitled "A randomized, double-blind, placebo controlled, multi-center study to assess the effect of ranolazine on outcomes in subjects with pulmonary hypertension and right ventricular dysfunction accompanied by a comparative study of cellular metabolism in subjects with pulmonary hypertension with and without right ventricular dysfunction". Subjects must enroll in companion treatment protocol to qualify for the imaging protocol.
The cardiac MRI portion of the study continued, but the PET portion of the study was discontinued due to funding.
The treatment protocol is registered under: NCT01839110. Due to funding issues, the completed study was registered under NCT02829034.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 11c-acetate and 18F-FDG, and cardiac MRI | Experimental | For each PET/CT imaging session subjects will receive a 15-25 millicurie intravenous injection of 11C-acetate and a 10 millicurie injection of 18F-FDG At baseline/6 months follow up, a cardiac MRI will be performed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 11C-acetate | Drug | For each PET/CT imaging session subjects will receive a 15-25 millicurie intravenous injection of 11C-acetate |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in RV Function | RV function as measured by cardiac MRI | 6 months |
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Inclusion Criteria:
Participation in the companion treatment protocol "A randomized, double-blind, placebo controlled, multi-center study to assess the effect of ranolazine on outcomes in subjects with pulmonary hypertension and right ventricular dysfunction accompanied by a comparative study of cellular metabolism in subjects with pulmonary hypertension with and without right ventricular dysfunction"
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yuchi Han, MD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
Data available upon request
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| ID | Title | Description |
|---|---|---|
| FG000 | 11c-acetate and 18F-FDG, and Cardiac MRI | For each PET/CT imaging session subjects will receive a 15-25 millicurie intravenous injection of 11C-acetate and a 10 millicurie injection of 18F-FDG At baseline/6 months follow up, a cardiac MRI will be performed. 11C-acetate: For each PET/CT imaging session subjects will receive a 15-25 millicurie intravenous injection of 11C-acetate [18F]Fluoro-2-deoxy-2-D-glucose: For each PET/CT imaging session subjects will receive a 10 millicurie injection of 18F-FDG Cardiac MRI: Cardiac MRI is performed at 6 months to measure any change in structure and function of the treatment groups. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 11c-acetate and 18F-FDG, and Cardiac MRI | For each PET/CT imaging session subjects will receive a 15-25 millicurie intravenous injection of 11C-acetate and a 10 millicurie injection of 18F-FDG At baseline/6 months follow up, a cardiac MRI will be performed. 11C-acetate: For each PET/CT imaging session subjects will receive a 15-25 millicurie intravenous injection of 11C-acetate [18F]Fluoro-2-deoxy-2-D-glucose: For each PET/CT imaging session subjects will receive a 10 millicurie injection of 18F-FDG Cardiac MRI: Cardiac MRI is performed at 6 months to measure any change in structure and function of the treatment groups. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Changes in RV Function | RV function as measured by cardiac MRI | Patient completed the cardiac MRI at 6 months, changes in RVEF | Posted | Least Squares Mean | Standard Error | percentage | 6 months |
|
7 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 11c-acetate and 18F-FDG, and Cardiac MRI | For each PET/CT imaging session subjects will receive a 15-25 millicurie intravenous injection of 11C-acetate and a 10 millicurie injection of 18F-FDG At baseline/6 months follow up, a cardiac MRI will be performed. 11C-acetate: For each PET/CT imaging session subjects will receive a 15-25 millicurie intravenous injection of 11C-acetate [18F]Fluoro-2-deoxy-2-D-glucose: For each PET/CT imaging session subjects will receive a 10 millicurie injection of 18F-FDG Cardiac MRI: Cardiac MRI is performed at 6 months to measure any change in structure and function of the treatment groups. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Yuchi Han | University of Pennsylvania | 215-662-2855 | yuchi.han@uphs.upenn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 11, 2014 | Nov 29, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| C438206 | carbon-11 acetate |
| D019788 | Fluorodeoxyglucose F18 |
| ID | Term |
|---|---|
| D003847 | Deoxyglucose |
| D003837 | Deoxy Sugars |
| D002241 | Carbohydrates |
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| OTHER |
| The Cardiovascular Medical Research and Education Fund | OTHER |
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| [18F]Fluoro-2-deoxy-2-D-glucose | Drug | For each PET/CT imaging session subjects will receive a 10 millicurie injection of 18F-FDG |
|
|
| Cardiac MRI | Other | Cardiac MRI is performed at 6 months to measure any change in structure and function of the treatment groups. |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
|
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| 0 |
| 21 |
| 0 |
| 21 |
| 0 |
| 21 |
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| D002318 |
| Cardiovascular Diseases |