- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01572077
Rt Ventricular Substrate Metabolism as a Predictor of Rt Heart Failure in Patients With Pulmonary Arterial Hypertension (RVMET)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ontario
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Ottawa, Ontario, Canada, K1Y4W7
- University of OttawaHeart Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: FTHA/GDF PET imaging
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. |
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).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cardiopulmonary death OR clinical right heart failure hospitalization
Time Frame: 1year
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Clinical RHF admission requiring ONE of the following:intravenous diuretics or an increase in oral diuretics >50%of baseline for at least 7 days.
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1year
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in right ventricular size and function as measured by cardiac MRI, between baseline and 1 year.
Time Frame: 1 year
|
1 year
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Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2010539-01H
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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