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Look at Way the Heart Functions in People With Pulmonary Hypertension (PH) Who Have Near Normal Right Ventricle (RV) Function and People With Pulmonary Hypertension Who Have Impaired RV Function. Using Imaging Studies PET Scan and Cardiac MRI.

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Brigham and Women's Hospital
Sponsor:
Collaborators:
University of Pennsylvania
University of Maryland
Yale University
Information provided by (Responsible Party):
Aaron Waxman MD PhD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01953965
First received: September 26, 2013
Last updated: July 23, 2014
Last verified: July 2014
  Purpose

The purpose of this study to look at differences in the way the heart functions in people with pulmonary hypertension (PH) who have near normal right ventricle (RV) function and people with pulmonary hypertension who have impaired RV function. The right ventricle is a chamber of the heart that pumps blood into the pulmonary artery (the artery that carried blood from the heart to the lungs). Learning more about how the heart is working in people with pulmonary hypertension may help researchers to understand how to better treat pulmonary hypertension and prevent the disease from getting worse.

To do this, we will use two imaging techniques, MRI (Magnetic Resonance Imaging) and PET/CT (Positron Emission Tomography/Computed Tomography). MRI uses a strong magnet and radio waves to take pictures of your heart. A PET/CT scan combines a PET and CT scan into one machine. A CT scan uses x-0rays to take a 3-day picture of the inside of your body, while a PET scan measures small amounts of radiation from a dye called a "tracer" that we inject into your veins.

You will be given two tracers as part of the PET/CT scan. A tracer is a special type of dye with a small amount of radioactivity in it. The tracers that are used in this study are called [18F]fluorodeoxyglucose (FDG) and [11C]-acetate.

In order to take part in this study, you must also have agreed to take part in a companion study. In the companion study, we are trying to learn whether the drug ranolazine is safe and effective in people with PH.


Condition Intervention Phase
Pulmonary Arterial Hypertension
Chronic Thromboembolic Pulmonary Hypertension
Drug: 11C-acetate
Drug: [18F]Fluoro-2-deoxy-2-D-glucose
Drug: MultiHance
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: 11C-acetate/18Fluorodeoxyglucose-FDG PET/Cardiac MRI in Pulmonary Hypertension

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • 1. To demonstrate that there are differences in metabolism and function between subjects with near normal RV function and persistent RV dysfunction as defined by CMR Right Ventricular Ejection Fraction (RVEF) of <= 40%. [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
    Compare myocardial oxygen consumption, FDG uptake, and myocardial perfusion at baseline for subjects with near normal right ventricular function and those with persistent right ventricular dysfunction.

  • 2. To measure changes in RV energy and contractility in subjects with persistent RV dysfunction using serial 11C-acetate and 18F-FDG PET/CT and CMR. perfusion [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
    Compare myocardial oxygen consumption, FDG uptake, and myocardial perfusion at baseline for subjects with near normal right ventricular function and those with persistent right ventricular dysfunction.


Secondary Outcome Measures:
  • Changes in myocardial structure and function [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Using CMR, comparing myocardial structure and function in patients treated with ranolazine or placebo.


Estimated Enrollment: 36
Study Start Date: September 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 11c-acetate and 18F-FDGI
For each PET/CT imaging session subjects will receive a 15-25 millicurie intravenous injection of 11C-acetate and 10 millicurie injection of 18F-FDG at baseline/6months follow-up, a cardiac MRI will be performed.
Drug: 11C-acetate
For each PET/CT imaging session subject 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
Drug: MultiHance
Cardiac MRI is performed at 6 months to measure any change in structure and function of the treatment groups. MultiHance is the contrast that will be given to subjects.

Detailed Description:

Historically, RV failure had been described as a stereotyped response to hemodynamic overload. More recent large patient cohort data suggests that RV, independently from Pulmonary Arterial Pressure (PAP), predicts mortality. Thus, a recent hypothesis suggests that individual genetic differences dysregulate cardiomyocyte function and, in doing so, predispose to RV failure in humans, control patient-specific manifestations of disease, and thus would represent key diagnostic markers and therapeutic targets. In fact, multiple key metabolic regulatory factors have been found to be altered in RV failure, any one of which could contribute to individual predisposition to RV failure. Based on their established functions in left ventricular injury and metabolism19 and known alterations in right ventricular failure20, we propose to evaluate metabolic dysfunction of the RV using positron emission topography (PET) and cardiac magnetic resonance imaging (CMR).

  Eligibility

Ages Eligible for Study:   18 Years to 72 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  • Anxiety or claustrophobia prohibiting completion of imaging
  • Inability to tolerate imaging procedures (up to 2 hours on scanner)
  • Moderate to severe chronic renal disease defined as an estimated glomerular filtration rate < 30 ml/min/1.73m2
  • Implantable cardioverter-defibrillator, pacemaker, hazardous metallic implants or any other contraindication to MRI
  • History of uncontrolled diabetes mellitus with fasting glucose > 150 mg/dL at the treatment protocol screening visit.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01953965

Contacts
Contact: Laurie Lawler, RN 617-525-9731 llawler@partners.org
Contact: Aaron Waxman, MD, PhD 617-525-9733 abwaxman@partners.org

Locations
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Laurie Lawler, RN    617-525-9731    llawler@partners.org   
Principal Investigator: Aaron Waxman, MD,PhD         
Sponsors and Collaborators
Brigham and Women's Hospital
University of Pennsylvania
University of Maryland
Yale University
Investigators
Principal Investigator: Aaron Waxman, MD, PhD Brigham and Women's Hospital
  More Information

No publications provided

Responsible Party: Aaron Waxman MD PhD, Director, Pulmonary Vascular Disease Program, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01953965     History of Changes
Other Study ID Numbers: CMREF-PH Imaging
Study First Received: September 26, 2013
Last Updated: July 23, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014