Phase 2 N=21 Diagnostic

11C-acetate/18Fluorodeoxyglucose-FDG PET/CT and Cardiac MRI in Pulmonary Hypertension

Pulmonary Hypertension

Bottom Line

View on ClinicalTrials.gov: NCT01917136 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2019

Primary outcome: Primary: Changes in RV Function — 7.56 percentage

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: 11C-acetate (Drug); [18F]Fluoro-2-deoxy-2-D-glucose (Drug); Cardiac MRI (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Pennsylvania
Primary completion: Oct 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Changes in RV Function	7.56	—

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.

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

View full record on ClinicalTrials.gov →

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.