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

NCT02237378 | Terminated

• 1 other identifier: 20140602
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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)

Conditions

Pulmonary Hypertension

Keywords

FDG lung and RV uptake

Outcome Measures

Primary Outcomes (1)

• Cardiac and pulmonary metabolism role in development of right heart failure in pulmonary hypertension in left heart disease.

  Relationship between lung fludeoxyglucose (FDG)uptake and hemodynamic type pulmonary hypertension using PET scanning

  Baseline

Study Arms (1)

FDG PET scan

EXPERIMENTAL

A PET scan using F-18 FDG, N-13 Ammonia will be performed

Radiation: FDG PET scan

Interventions

FDG PET scan RADIATION

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.

Also known as: F-18-FDG, N-13 ammonia

FDG PET scan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ottawa Heart Institute Research Corporation: lead

Study Sites (1)

University of OttawaHeart Institute

Ottawa, Ontario, K1Y4W7, Canada

Location

MeSH Terms

Conditions

Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular 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: SPONSOR

Study Record Dates

• First Submitted: August 29, 2014
• First Posted: September 11, 2014
• Study Start: December 1, 2014
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: August 31, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)