Phase 2
Completed N=21
11C-acetate/18Fluorodeoxyglucose-FDG PET/CT and Cardiac MRI in Pulmonary Hypertension
Source: ClinicalTrials.gov NCT01917136 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Feb 2019
Primary outcomePrimary: Changes in RV Function — 7.56 percentage
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in RV Function |
7.56 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01917136). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.