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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 October 2012 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: October 16, 2012
Last verified: October 2012
History of Changes
  Purpose

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)


Condition Intervention
Pulmonary Arterial Hypertension
 Radiation: 18 F- Fluoro-6-thiaheptadecanoic Acid ( FTHA)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Ottawa Heart Institute:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 60
Study Start Date: January 2011
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Control group

This arm will be 20 healthy, age and sex individuals to serve as normal controls. These subjects will have no known cardiac or pulmonary disease.

All controls will undergo a 2 day PET scan, echocardiogram, 6 minute hall walk

 Radiation: 18 F- Fluoro-6-thiaheptadecanoic Acid ( FTHA)

Following an overnight fast,a 60-90 min dynamic PET acquisition with an intravenous injection of 5 MBq/kg of FDG to measure myocardial glucose uptake.The same imaging procedure is repeated on the second day with FTHA to measure myocardial fatty acid uptake.

A cardiac MRI will be done at baseline for the control group and at 1 year for the patient group. The patient group undergo echocardiogram and cardiac MRI at baseline as part of routine clinical care. Baseline biomarkers will be drawn from both groups and from patient arm at 1 year follow up
Patient
This arm are patients with a diagnosis of pulmonary arterial hypertension and who have recently undergone a clinical right heart catheterization
 Radiation: 18 F- Fluoro-6-thiaheptadecanoic Acid ( FTHA)

Following an overnight fast,a 60-90 min dynamic PET acquisition with an intravenous injection of 5 MBq/kg of FDG to measure myocardial glucose uptake.The same imaging procedure is repeated on the second day with FTHA to measure myocardial fatty acid uptake.

A cardiac MRI will be done at baseline for the control group and at 1 year for the patient group. The patient group undergo echocardiogram and cardiac MRI at baseline as part of routine clinical care. Baseline biomarkers will be drawn from both groups and from patient arm at 1 year follow up

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01572077

Contacts
Contact: Rosemary Dunne, RN 613-798-5555 ext 19295 rdunne@ottawaheart.ca
Contact: Lisa M Mielniczuk, MD 613-761-4059 lmielniczuk@ottawaheart.ca

Locations
Canada, Ontario
University of OttawaHeart Institute Recruiting
Ottawa, Ontario, Canada, K1Y4W7
Principal Investigator: Lisa M Mielniczuk, MD            
Sponsors and Collaborators
University of Ottawa Heart Institute
Heart and Stroke Foundation of Ontario
Investigators
Principal Investigator: Lisa M Mielniczuk, MD University of Ottawa Heart Institiute
  More Information

No publications provided

Responsible Party: Lisa Mielniczuk, Co- Medical Director Pulmonary Hypertension Clinic, University of Ottawa Heart Institute
ClinicalTrials.gov Identifier: NCT01572077     History of Changes
Other Study ID Numbers: 2010539-01H
Study First Received: March 29, 2012
Last Updated: October 16, 2012
Health Authority: Canada: Health Canada

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

ClinicalTrials.gov processed this record on May 16, 2013