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

NCT01572077 | Completed

• 1 other identifier: 2010539-01H
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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)

Conditions

Pulmonary Arterial Hypertension

Outcome Measures

Primary Outcomes (1)

• 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.

  1year

Secondary Outcomes (1)

• Change in right ventricular size and function as measured by cardiac MRI, between baseline and 1 year.

  1 year

Study Arms (1)

FTHA/GDF PET imaging

EXPERIMENTAL

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.

Interventions

FTHA, FDG PET imaging. RADIATION

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).

FTHA/GDF PET imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ottawa Heart Institute Research Corporation: lead
• Heart and Stroke Foundation of Ontario: collaborator

Study Sites (1)

University of OttawaHeart Institute

Ottawa, Ontario, K1Y4W7, Canada

Location

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Interventions

14-fluoro-6-thiaheptadecanoic acid

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Lisa M Mielniczuk, MD

  University of Ottawa Heart Institiute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co- Medical Director Pulmonary Hypertension Clinic

Study Record Dates

• First Submitted: March 29, 2012
• First Posted: April 5, 2012
• Study Start: January 1, 2011
• Primary Completion: December 31, 2016
• Study Completion: July 26, 2017
• Last Updated: April 13, 2018

Record last verified: 2018-04

Locations

CA (1)