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

Phase 2

Completed

• Conditions: Pulmonary Hypertension
• Interventions: Drug: 11C-acetate; Drug: [18F]Fluoro-2-deoxy-2-D-glucose; Other: Cardiac MRI

• Registration Number: NCT01917136
• Lead Sponsor: University of Pennsylvania

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.

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-08-03
• Study First Submitted QC: 2013-08-03
• Study First Posted: 2013-08-06
• Primary Completion: 2018-10
• Study Completion: 2018-10
• Status Verified: 2018-11
• Results First Submitted: 2018-11-30
• Results First Submitted QC: 2019-01-14
• Last Update Submitted: 2019-01-14
• Results First Posted: 2019-02-05
• Last Update Posted: 2019-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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"

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
11c-acetate and 18F-FDG, and cardiac MRI	[18F]Fluoro-2-deoxy-2-D-glucose	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 and 18F-FDG, and cardiac MRI	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 and 18F-FDG, and cardiac MRI	11C-acetate	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.

Primary Outcome Measures

Name	Time	Method
Changes in RV Function	6 months	RV function as measured by cardiac MRI

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States