A Pilot Study Evaluating Heart and Lung Metabolism in Pulmonary Hypertension Associated With Left Heart Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02237378
Recruitment Status : Recruiting
First Posted : September 11, 2014
Last Update Posted : May 17, 2018
Information provided by (Responsible Party):
Ottawa Heart Institute Research Corporation

Brief Summary:

Right ventricular (RV) failure is the leading cause of death in pulmonary arterial hypertension. (PAH) Right ventricular ejection fraction is one of the most important predictors of prognosis in heart failure patients regardless of cause. It is estimated that 30-50% of patients with heart failure and preserved ejection fraction (HFpEF) have right ventricular dysfunction and up to 70% of these patients will have significant pulmonary hypertension (PH), both of which are related to much worse prognosis. Right ventricular failure is becoming an increasingly prevalent and significant cause of morbidity in patients with left heart disease. Despite the significance of RV function to survival, there are no therapies available that directly or selectively improve RV function.

The overall theme of this research project is to evaluate the mechanisms that contribute to the cause of right heart failure. This small study is designed to look at the role of heart and lung metabolism and pulmonary hypertension as they relate to the development of right heart failure in cardiovascular disease.(PH-LHD)

Condition or disease Intervention/treatment Phase
Pulmonary Hypertension Radiation: FDG PET scan Not Applicable

Detailed Description:

The hemodynamic definition of PH-LHD involves a mean pulmonary artery pressure (mPAP) >25mm Hg at rest and pulmonary capillary wedge pressure (PCWP) of ≥15.The coexistence of mitral insufficiency is also a characteristic of PH-LHD. HFpEF is a condition caused by impaired relaxation of a stiffened myocardium as a consequence of an increased load to the left ventricle due to elevated systemic pressures.

Pulmonary hemodynamics can be used to classify PH LHD as either passive or reactive, irrespective of LV function. It has been suggested that diastolic pressure gradient (DPG) may offer added prognostic value as a more accurate indicator of pulmonary vascular remodeling.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Evaluation of Cardiopulmonary Metabolism and Pulmonary Vascular Remodeling in Pulmonary Hypertension Associated With Left Heart Disease
Study Start Date : December 2014
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: FDG PET scan
A PET scan using F-18 FDG, N-13 Ammonia will be performed
Radiation: FDG PET scan
Following an overnight fast, subjects will be positioned in the Discovery 660 PET/VCT scanner. Following a scout scan to confirm patient positioning, low dose xray CT scan is performed for photon attenuation. A 20 minute dynamic PET scan is started simultaneously with 3 MBq/kg of N-13 ammonia to measure myocardial perfusion. Following N-13 decay,a 60 minute dynamic PET scan with 3 MBq/kg F-18- FDG to measure myocardial glucose uptake. Blood sampling for glucose and insulin will occur at pre specified time points throughout the scan.
Other Names:
  • F-18-FDG
  • N-13 ammonia

Primary Outcome Measures :
  1. Cardiac and pulmonary metabolism role in development of right heart failure in pulmonary hypertension in left heart disease. [ Time Frame: Baseline ]
    Relationship between lung fludeoxyglucose (FDG)uptake and hemodynamic type pulmonary hypertension using PET scanning

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients must be able to provide their written informed consent to participate in the study after having received adequate previous information and prior to any study specific procedures.
  • At least 18 years of age at the time of screening.
  • Patients with PH secondary to left heart disease (known as group II PH) defined as a mean PAP>25 mmHg and a PCWP of ≥15 mmHg.

Exclusion Criteria:

  • All other types of pulmonary hypertension including Dana Point Classification Group 1, 3, 5.
  • Type II Diabetes mellitus requiring medical therapy
  • Previous myocardial infarction within the 3 months prior to screening.
  • Renal insufficiency (glomerular filtration rate < 30 ml/min.
  • ALT or AST > 3times ULN and/or severe hepatic insufficiency.
  • Contraindication to MRI imaging.

Information from the National Library of Medicine

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 identifier (NCT number): NCT02237378

Contact: Lisa M Mielniczuk, MD 613 696 7274
Contact: Rosemary Dunne, RN 613 696 7000 ext 19295

Canada, Ontario
University of OttawaHeart Institute Recruiting
Ottawa, Ontario, Canada, K1Y4W7
Contact: Lisa M Mielniczuk, MD    613 696-7274   
Contact: Rosemary Dunne, RN    613 696 7000 ext 19295   
Principal Investigator: Lisa M Mielniczuk, MD         
Sub-Investigator: Duncan J Stewart, MD         
Sub-Investigator: George Chandy, MD         
Sub-Investigator: Vladimir Contreras, MD         
Sub-Investigator: Ross Davies, MD         
Sub-Investigator: Elena Pena, MD         
Sub-Investigator: Carole Dennie, MD         
Sub-Investigator: Rebecca Thornhill, PhD         
Sub-Investigator: Rob Beanlands, MD         
Sub-Investigator: Rob DeKemp, PhD         
Sponsors and Collaborators
Ottawa Heart Institute Research Corporation
Principal Investigator: Lisa M Mielniczuk, MD University of Ottawa Heart Institiute

Responsible Party: Ottawa Heart Institute Research Corporation Identifier: NCT02237378     History of Changes
Other Study ID Numbers: 20140602
First Posted: September 11, 2014    Key Record Dates
Last Update Posted: May 17, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Manuscript preparation in progress
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Upon study completion and data analysis. Possible timeline would be Dec 2019
Access Criteria: not yet available

Keywords provided by Ottawa Heart Institute Research Corporation:
FDG lung and RV uptake

Additional relevant MeSH terms:
Heart Diseases
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Fluorodeoxyglucose F18
Molecular Mechanisms of Pharmacological Action