Back to resultsRt Ventricular Substrate Metabolism as a Predictor of Rt Heart Failure in Patients With Pulmonary Arterial Hypertension (RVMET)
Primary Purpose
Pulmonary Arterial Hypertension
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
FTHA, FDG PET imaging.
Sponsored by
About this trial
This is an interventional basic science trial for Pulmonary Arterial Hypertension
Eligibility Criteria
Inclusion Criteria:(PATIENTS)
- Patients with diagnosis of Category 1 pulmonary arterial hypertension due to any of the following: idiopathic, familial, associated with connective tissue disease, HIV disease or anorexigen use.
- All patients who will require a right heart catheterization for further clinical management and/or diagnosis.
- Patients will be considered eligible if they have no significant coronary artery disease (stenosis > 70% in a proximal or mid major coronary artery) or moderate coronary artery disease (60-70%) with abnormal left ventricular function (EF<50%)
- Patients will be considered eligible in the absence of current or recent evidence of right heart failure.
- No previous hospital admission or requirements of intravenous diuretics for right heart failure within 6 months of enrolment.
- No increase in oral diuretics to control fluid volume within 6 months prior to enrolment
- No current symptoms and signs of fluid retention or right heart strain, including any of the following: development of new ascites or peripheral edema > = 2+, JVP >7 cm above the sternal angle or a right atrial pressure >14 mmHg at the time of right heart catheterization.
- In addition, we will include a small cohort of up to 15 patients with PAH and current RHF.
Exclusion Criteria:
- Patients with known significant coronary artery disease(defined as known stenosis >70% in a proximal or mid major artery or moderate coronary artery disease (60-70%)in a coronary artery and associated left ventricular ejection fraction <50%.
- Patients with diabetes mellitus who require the use of oral hypoglycemics and or insulin.
- Implantable metal devices, incompatible with magnetic resonance imaging.
- Other contraindications of magnetic resonance imaging.
Normal Control Subjects:
- Subjects will have no known cardiac or pulmonary disease.
- Normal ventricular function and estimated pulmonary pressures on echocardiogram.
Sites / Locations
- University of OttawaHeart Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
FTHA/GDF PET imaging
Arm Description
This study plans to enrol 60 subjects with Type I pulmonary arterial hypertension (PAH) and 20 healthy, age and sex individuals to serve as normal controls. These subjects will have no known cardiac or pulmonary disease. Both groups will undergo FTHA/FDG PET imaging.
Outcomes
Primary Outcome Measures
Cardiopulmonary death OR clinical right heart failure hospitalization
Clinical RHF admission requiring ONE of the following:intravenous diuretics or an increase in oral diuretics >50%of baseline for at least 7 days.
Secondary Outcome Measures
Change in right ventricular size and function as measured by cardiac MRI, between baseline and 1 year.
Full Information
NCT ID
NCT01572077
First Posted
March 29, 2012
Last Updated
April 12, 2018
Sponsor
Ottawa Heart Institute Research Corporation
Collaborators
Heart and Stroke Foundation of Ontario
1. Study Identification
Unique Protocol Identification Number
NCT01572077
Brief Title
Rt Ventricular Substrate Metabolism as a Predictor of Rt Heart Failure in Patients With Pulmonary Arterial Hypertension
Acronym
RVMET
Official Title
Rt Ventricular Substrate Metabolism as a Predictor of Rt Heart Failure in Patients With Pulmonary Arterial Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
January 2011 (Actual)
Primary Completion Date
December 31, 2016 (Actual)
Study Completion Date
July 26, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ottawa Heart Institute Research Corporation
Collaborators
Heart and Stroke Foundation of Ontario
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate patterns of metabolic activity in the heart of patients with pulmonary arterial hypertension(PAH). Patients with PAH are at risk of developing weakness or failure of the right side of the heart.It is possible that there is a relationship between the development of heart failure and the way the heart uses energy sources, such as sugar. This study is designed to evaluate the way the heart uses sugar uptake in patients with PAH using positron emission tomography(PET imaging)
Detailed Description
PAH results in premature death as a result of right ventricular dysfunction. However, there are substantial differences among patients in their tendency to develop right heart failure. This study proposes to determine if right ventricular (RV) changes can predict the development of right heart failure in patients with PAH.
In addition, the study aims to evaluate the relationship of right ventricular metabolism to other physiologic responses in PAH,including:pulmonary vascular resistance, serum BNP and changes in cardiac hypertrophy and function. In conjunction with hemodynamic measurements, biomarkers and cardiac magnetic resonance imaging (MRI); RV metabolism will be evaluated with (18F) FTHA and (18F)FDG cardiac PET imaging.
A cohort of 20 age sex matched individuals will serve as normal controls. These subjects will have no known cardiac or pulmonary disease with normal ventricular function and estimates pulmonary pressures on echocardiogram.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Arterial Hypertension
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FTHA/GDF PET imaging
Arm Type
Experimental
Arm Description
This study plans to enrol 60 subjects with Type I pulmonary arterial hypertension (PAH) and 20 healthy, age and sex individuals to serve as normal controls. These subjects will have no known cardiac or pulmonary disease.
Both groups will undergo FTHA/FDG PET imaging.
Intervention Type
Radiation
Intervention Name(s)
FTHA, FDG PET imaging.
Intervention Description
Subjects will undergo PET scans on 2 different days using 2 separate tracers, FTHA(fluoro-6-this-hepadecanoic acid) and FDG(fluoro-2- deoxy-glucose).
Primary Outcome Measure Information:
Title
Cardiopulmonary death OR clinical right heart failure hospitalization
Description
Clinical RHF admission requiring ONE of the following:intravenous diuretics or an increase in oral diuretics >50%of baseline for at least 7 days.
Time Frame
1year
Secondary Outcome Measure Information:
Title
Change in right ventricular size and function as measured by cardiac MRI, between baseline and 1 year.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:(PATIENTS)
Patients with diagnosis of Category 1 pulmonary arterial hypertension due to any of the following: idiopathic, familial, associated with connective tissue disease, HIV disease or anorexigen use.
All patients who will require a right heart catheterization for further clinical management and/or diagnosis.
Patients will be considered eligible if they have no significant coronary artery disease (stenosis > 70% in a proximal or mid major coronary artery) or moderate coronary artery disease (60-70%) with abnormal left ventricular function (EF<50%)
Patients will be considered eligible in the absence of current or recent evidence of right heart failure.
No previous hospital admission or requirements of intravenous diuretics for right heart failure within 6 months of enrolment.
No increase in oral diuretics to control fluid volume within 6 months prior to enrolment
No current symptoms and signs of fluid retention or right heart strain, including any of the following: development of new ascites or peripheral edema > = 2+, JVP >7 cm above the sternal angle or a right atrial pressure >14 mmHg at the time of right heart catheterization.
In addition, we will include a small cohort of up to 15 patients with PAH and current RHF.
Exclusion Criteria:
Patients with known significant coronary artery disease(defined as known stenosis >70% in a proximal or mid major artery or moderate coronary artery disease (60-70%)in a coronary artery and associated left ventricular ejection fraction <50%.
Patients with diabetes mellitus who require the use of oral hypoglycemics and or insulin.
Implantable metal devices, incompatible with magnetic resonance imaging.
Other contraindications of magnetic resonance imaging.
Normal Control Subjects:
Subjects will have no known cardiac or pulmonary disease.
Normal ventricular function and estimated pulmonary pressures on echocardiogram.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa M Mielniczuk, MD
Organizational Affiliation
University of Ottawa Heart Institiute
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of OttawaHeart Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y4W7
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Rt Ventricular Substrate Metabolism as a Predictor of Rt Heart Failure in Patients With Pulmonary Arterial Hypertension
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