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

U

University of Ottawa Heart Institute

Status

Terminated

Conditions

Pulmonary Hypertension

Treatments

Radiation: FDG PET scan

Study type

Interventional

Funder types

Other

Identifiers

NCT02237378
20140602

Details and patient eligibility

About

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)

Full 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.

Enrollment

2 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

2 participants in 1 patient group

FDG PET scan
Experimental group
Description:
A PET scan using F-18 FDG, N-13 Ammonia will be performed
Treatment:
Radiation: FDG PET scan

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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