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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2018-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

PET Image in PAH Patients

NCT05452889

Pulmonary Arterial Hypertension

RECRUITING EARLY_PHASE1

Novel MRI Techniques in the Evaluation of Pulmonary Vascular Disease

NCT02026531

Pulmonary Hypertension

COMPLETED PHASE1/PHASE2

Novel Quantitative Magnetic Resonance Imaging (MRI) Measures in the Assessment and Follow-up of Patients With Pulmonary Hypertension (PH)

NCT04088279

Pulmonary Hypertension

UNKNOWN NA

Cardiac MRI in Pulmonary Hypertension

NCT02485977

Pulmonary Hypertension

COMPLETED

Cardiac Magnetic Resonance Imaging and Pulmonary Perfusion

NCT01100008

Pulmonary Hypertension

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pulmonary Hypertension

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

11C-acetate

Intervention Type DRUG

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

Intervention Type DRUG

For each PET/CT imaging session subjects will receive a 10 millicurie injection of 18F-FDG

Cardiac MRI

Intervention Type OTHER

Cardiac MRI is performed at 6 months to measure any change in structure and function of the treatment groups.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

11C-acetate

For each PET/CT imaging session subjects will receive a 15-25 millicurie intravenous injection of 11C-acetate

Intervention Type DRUG

[18F]Fluoro-2-deoxy-2-D-glucose

For each PET/CT imaging session subjects will receive a 10 millicurie injection of 18F-FDG

Intervention Type DRUG

Cardiac MRI

Cardiac MRI is performed at 6 months to measure any change in structure and function of the treatment groups.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

18F-FDG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No