Pilot Study to Evaluate Right Ventricular Function With Riociguat in CTEPH

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02094001
• Date of registration: 17/03/2014
• Prospective Registration: Yes
• Primary sponsor: Ottawa Heart Institute Research Corporation
• Public title: Pilot Study to Evaluate Right Ventricular Function With Riociguat in CTEPH
• Scientific title: Evaluation of Right Ventricular Function and Metabolism Following Riociguat for the Treatment of Chronic Thromboembolic Pulmonary Hypertension- Images of Rio
• Date of first enrolment: May 2014
• Target sample size: 6
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02094001
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Canada

Contacts

• Name: Lisa M Mielniczuk, MD
• Affiliation: Ottawa Heart Institute Research Corporation

Key inclusion & exclusion criteria

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.

- Receiving riociguat therapy for CTEPH.

- Patients with inoperable CTEPH or persistent or recurrent PH, after undergoing
pulmonary endarterectomy.

- CTEPH diagnosis will be based on either Ventilation/ Perfusion scan (V/Q), pulmonary
angiography or computed tomography pulmonary angiography..

- Clinical right heart catheterization performed confirming mean pulmonary artery
pressure (mPAP >25 mmHg).

- Pulmonary vascular resistance (PVR) > 300 dyne/sec/cm5

Exclusion Criteria:

- • All types of pulmonary hypertension except Dana Point Classification Group 4 (1).

- Patients who are currently taking Phosphodiesterase type 5 (PDE-5) inhibitors,
ERAs and prostanoids = 3 days prior to start of riociguat treatment.

- Pulmonary endarterectomy surgery within 3 months of screening.

- Epicardial coronary artery disease (Ejection Fraction <40%).

- Previous myocardial infarction within the 3 months prior to screening.

- Severe proven or suspected coronary artery disease (CCS Angina Classification
II-IV), and/or requiring nitrates.

- Uncontrolled arterial hypertension (systolic blood pressure> 180 mmHg and/or
diastolic BP> 110 mmHg.

- Systolic blood pressure <95mmHg.

- Resting heart rate in an awake patient <50 beats per minute (bpm) or >105 bpm.

- History of uncontrolled atrial fibrillation within the last 3 months prior to
screening.

- Hypertrophic obstructive cardiomyopathy.

- Clinical evidence of symptomatic atherosclerotic disease (peripheral artery
disease).

- Pregnant or breastfeeding women or women with childbearing potential not using
highly effective contraception methods.

- Renal insufficiency (glomerular filtration rate < 30 ml/min.

- ALT or AST > times upper limit of normal( ULN) and/or severe hepatic
insufficiency.

- Contraindication to MRI imaging.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Chronic Thromboembolic Pulmonary Hypertension

Intervention(s)

Radiation: Cardiac PET imaging using F-18-FDG, N-13 ammonia( NH3)

Primary Outcome(s)

Evidence of changes in glucose metabolism and myocardial RV blood flow in patients treated with riociguat using PET imaging. [Time Frame: After 24 weeks of treatment with riociguat.]

Secondary Outcome(s)

Evidence of improved RV function and volumes using 3D echocardiography and magnetic resonance imagining (MRI) [Time Frame: baseline and 24 weeks]

Secondary ID(s)

20130903-01H

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Bayer