Skip to content

Efficacy and safety of refined balloon pulmonary angioplasty combined with riociguat in the treatment of inoperable chronic thromboembolic pulmonary hypertension: a single center, open label, prospective, optimal, randomized, parallel controlled clinical study (PRACTICE study)

Efficacy and safety of refined balloon pulmonary angioplasty combined with riociguat in the treatment of inoperable chronic thromboembolic pulmonary hypertension: a single center, open label, prospective, optimal, randomized, parallel controlled clinical study (PRACTICE study)

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000032403
Enrollment
Unknown
Registered
2020-04-27
Start date
2021-01-01
Completion date
Unknown
Last updated
2020-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic thromboembolic pulmonary hypertension

Interventions

Riociguat Group:Riociguat
Riociguat+BPA Group:Riociguat and BPA

Sponsors

Shanghai Pulmonary Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: (1) Over 18 years old; (2) Right cardiac catheter: mean pulmonary artery pressure (mPAP) >= 25 mm Hg, pulmonary arteriole pressure (PAWP) >= 15 mm Hg and pulmonary vascular resistance (PVR) >= 3 wood units (240 dyn·s·CM-5); (3) CTPA or pulmonary ventilation perfusion imaging or pulmonary arteriography confirmed the presence of pulmonary embolism; (4) Patients with non central CTEPH are not suitable for pulmonary endarterectomy (PEA), or they refuse to do pea, or they are in poor condition and cannot tolerate pea; (5) CTEPH patients with who cardiac function grade II or above; (6) Sign written informed consent.

Exclusion criteria

Exclusion criteria: (1) Other types of pulmonary hypertension; (2) The patient refused to sign the informed consent or could not cooperate with the investigator during the trial; (3) Patients or their families refused to undergo balloon pulmonary angioplasty; (4) Patients with contraindications to the use of lyoxygenase; (5) Patients who used other pulmonary hypertension targeting drugs, drugs that could not be used with riociguat, and drugs that affected the blood concentration of riociguat; (6) Severe chronic or acute diseases of liver, kidney or central nervous system; (7) With unstable angina, or with a history of myocardial infarction, stroke or life-threatening arrhythmia within 6 months before the trial; (8) Patients who cannot lie on the operating table for a long time due to mental factors; (9) Patients in acute infection stage; (10) Active hemoptysis patients.

Design outcomes

Primary

MeasureTime frame
Pulmonary vascular resistance;

Secondary

MeasureTime frame
mean pulmonary artery pressure;Cardiac output;6-minute walking distance;WHO-FC;Quality of life score;NT-proBNP;TAPSE;Area of right atrium;Eccentricity index;pericardial effusion;

Countries

China

Contacts

Public ContactWang Lan

Shanghai Pulmonary Hospital

wanglan198212@163.com+86 13651682766

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Sep 14, 2026