Rt Ventricular Substrate Metabolism as a Predictor of Rt Heart Failure in Patients With Pulmonary Arterial Hypertension (RVMET)
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|ClinicalTrials.gov Identifier: NCT01572077|
Recruitment Status : Completed
First Posted : April 5, 2012
Last Update Posted : April 13, 2018
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Arterial Hypertension||Radiation: FTHA, FDG PET imaging.||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Rt Ventricular Substrate Metabolism as a Predictor of Rt Heart Failure in Patients With Pulmonary Arterial Hypertension|
|Actual Study Start Date :||January 2011|
|Actual Primary Completion Date :||December 31, 2016|
|Actual Study Completion Date :||July 26, 2017|
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.
Radiation: 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).
- Cardiopulmonary death OR clinical right heart failure hospitalization [ Time Frame: 1year ]Clinical RHF admission requiring ONE of the following:intravenous diuretics or an increase in oral diuretics >50%of baseline for at least 7 days.
- Change in right ventricular size and function as measured by cardiac MRI, between baseline and 1 year. [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01572077
|University of OttawaHeart Institute|
|Ottawa, Ontario, Canada, K1Y4W7|
|Principal Investigator:||Lisa M Mielniczuk, MD||University of Ottawa Heart Institiute|