Rt Ventricular Substrate Metabolism as a Predictor of Rt Heart Failure in Patients With Pulmonary Arterial Hypertension (RVMET)

This study is currently recruiting participants.
Verified March 2014 by University of Ottawa Heart Institute
Sponsor:
Collaborator:
Heart and Stroke Foundation of Ontario
Information provided by (Responsible Party):
Lisa Mielniczuk, University of Ottawa Heart Institute
ClinicalTrials.gov Identifier:
NCT01572077
First received: March 29, 2012
Last updated: March 12, 2014
Last verified: March 2014

March 29, 2012
March 12, 2014
January 2011
September 2016   (final data collection date for primary outcome measure)
Cardiopulmonary death OR clinical right heart failure hospitalization [ Time Frame: 1year ] [ Designated as safety issue: No ]
Clinical RHF admission requiring ONE of the following:intravenous diuretics or an increase in oral diuretics >50%of baseline for at least 7 days.
Cardiopulmonary death OR clinical right heart failure hospitalization [ Time Frame: 1year ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01572077 on ClinicalTrials.gov Archive Site
Change in right ventricular size and function as measured by cardiac MRI, between baseline and 1 year. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Rt Ventricular Substrate Metabolism as a Predictor of Rt Heart Failure in Patients With Pulmonary Arterial Hypertension
Rt Ventricular Substrate Metabolism as a Predictor of Rt Heart Failure in Patients With Pulmonary Arterial Hypertension

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)

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Pulmonary Arterial Hypertension
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).
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.

Intervention: Radiation: FTHA, FDG PET imaging.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
December 2016
September 2016   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact: Rosemary Dunne, RN 613-798-5555 ext 19295 rdunne@ottawaheart.ca
Contact: Lisa M Mielniczuk, MD 613-761-4059 lmielniczuk@ottawaheart.ca
Canada
 
NCT01572077
2010539-01H
No
Lisa Mielniczuk, University of Ottawa Heart Institute
University of Ottawa Heart Institute
Heart and Stroke Foundation of Ontario
Principal Investigator: Lisa M Mielniczuk, MD University of Ottawa Heart Institiute
University of Ottawa Heart Institute
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP