Chronic Thromboembolic Pulmonary Hypertension Clinical Trial
Official title:
Evaluation of Right Ventricular Function and Metabolism Following Riociguat for the Treatment of Chronic Thromboembolic Pulmonary Hypertension- Images of Rio
Chronic thromboembolic Pulmonary hypertension(CTEPH) is characterized by obstruction of the
pulmonary vasculature, leading to increased pulmonary vascular resistance, progressive
pulmonary hypertension (PH) and right ventricular failure- most common cause of death for
patients with PH. Riociguat, (ADEMPAS) is a member of a new class of drug recently approved
in Canada for the treatment of CTEPH.
This pilot study is designed to assess if at least 24 weeks of treatment with riociguat will
show changes in glucose metabolism and improved resting myocardial blood flow using positron
emission tomography ( PET ) imaging to measure myocardial function. The response between both
treatment naive patients as well as patients on maximally tolerated dose of riociguat with
tratment duration of at least 3 months will be included.
It remains unclear as to why certain patients with PH develop right heart failure. Several
lines of evidence suggests alterations in right ventricular (RV) function may be precipitated
by RV ischemia. This ischemia results from both decreased right coronary artery perfusion
pressure and from arteriolar- capillary rarefaction. It has been proposed that this
contributes to insufficient oxygen delivery needed to support the increase RV demand in right
heart failure (RHF), this stimulating glycolytic shift. However, this glycolysis is
insufficient to compensate for suppression of glucose oxidation in severe right ventricular
hypertrophy (RVH), resulting in a state of RV hibernation and progressive RHF.
This study is designed to assess if 24 weeks of treatment with riociguat will be associated
with changes in glucose metabolism and improved RV blood flow using N-13-ammonia (NH3) to
measure myocardial perfusion.
We will assess the response in both treatment naive patients as well as patients who have
been titrated to maximally tolerated doses of riociguat with total treatment duration of at
least 3 months.
The assessment of quantitative myocardial blood flow will be combined with an advanced 3
dimensional echocardiographic assessment of RV volume and function and with cardiac magnetic
resonance (MR).
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