Pulmonary Hypertension
Conditions
Keywords
pulmonary hypertension, right ventricular function, 11C acetate, FDG, ranolazine
Brief summary
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.
Detailed description
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.
Interventions
DRUG11C-acetate
For each PET/CT imaging session subjects will receive a 15-25 millicurie intravenous injection of 11C-acetate
DRUG[18F]Fluoro-2-deoxy-2-D-glucose
For each PET/CT imaging session subjects will receive a 10 millicurie injection of 18F-FDG
OTHERCardiac MRI
Cardiac MRI is performed at 6 months to measure any change in structure and function of the treatment groups.
Sponsors
Brigham and Women's Hospital
University of Maryland
Yale University
Washington University School of Medicine
The Cardiovascular Medical Research and Education Fund
University of Pennsylvania
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
* Pregnancy or lactation: Women of childbearing potential must have a negative urine or blood pregnancy test on the day of the PET/CT scan. * Severe anxiety or claustrophobia prohibiting completion of imaging * Inability to tolerate imaging procedures (1 hour MRI, 30 min and 15 min PET) * Implantable cardioverter-defibrillator, Pacemaker, hazardous metallic implants or any other contraindication to MRI. * Uncontrolled diabetes mellitus with fasting glucose \> 150 mg/dL
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in RV Function | 6 months | RV function as measured by cardiac MRI |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 21 |
| Total | 21 |
Baseline characteristics
| Characteristic | 11c-acetate and 18F-FDG, and Cardiac MRI | — |
|---|---|---|
| Age, Continuous | 54.4 years STANDARD_DEVIATION 15.9 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 21 participants | — |
| Sex: Female, Male Female | 13 Participants | — |
| Sex: Female, Male Male | 8 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 21 |
| other Total, other adverse events | 0 / 21 |
| serious Total, serious adverse events | 0 / 21 |
Outcome results
Primary
Changes in RV Function
RV function as measured by cardiac MRI
Time frame: 6 months
Population: Patient completed the cardiac MRI at 6 months, changes in RVEF
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 11c-acetate and 18F-FDG, and Cardiac MRI | Changes in RV Function | 7.56 percentage | Standard Error 1.72 |