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Efficacy and safety of ambrisentan in maintenance hemodialysis patients with secondary pulmonary hypertension: a multicenter, randomized, controlled, open-label study

A multicenter randomized controlled, open-label study on the efficacy and safety of amrisentan in the treatment of secondary pulmonary hypertension in maintenance hemodialysis patients

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500102513
Enrollment
Unknown
Registered
2025-05-15
Start date
2025-06-01
Completion date
Unknown
Last updated
2025-05-19

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

Conditions

Uremia

Interventions

Control group:The control group was given conventional treatments such as blood pressure control, optimization and stabilization of hemoglobin levels, reduction of volume load, and correction of calci
Amrisentan treatment group:The experimental group was given amrisentan treatment (oral administration, 5mg, once a day) on the basis of conventional treatment.

Sponsors

The Second Affiliated Hospital of Army Medical University (Xinqiao Hospital)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Diagnosed with uremia, the diagnostic criteria met the diagnostic criteria of the "2023 KDIGO-CKD Evaluation and Management Clinical Practice Guidelines", and maintenance hemodialysis was performed for at least 3 months; (2) PASP was detected and calculated by color Doppler echocardiography, with PASP > 35mmHg; (3) The symptoms of PAH are WHO grade II or grade I symptoms; (4) Had never taken targeted drugs related to the treatment of PAH before enrollment; (5) The patient agrees to the treatment and signs the relevant informed consent form, and the patient can understand the research process; (6) Aged between 18 and 80;

Exclusion criteria

Exclusion criteria: (1) PAH is related to arterial or left heart disease, or pulmonary hypertension is caused by chronic thromboembolism; (2) Patients who are allergic to amrisentan or have contraindications for its use; (3) The patient participates in any other research and conducts research and/or receives or has received another research drug or intervention treatment (within the first month before signing the informed consent form); (4) Moderate to severe or severe liver disease (AST and ALT>) 2.5 times the upper limit range and total bilirubin 1.5 times the upper limit range; (5) The individual or legal guardian/representative is unable or unwilling to provide a written informed consent form.

Design outcomes

Primary

MeasureTime frame
The proportion of hospitalization due to aggravated pulmonary arterial hypertension;Pulmonary Arterial Systolic Pressure, PASP;

Secondary

MeasureTime frame
NT-proBNP;WHO Respiratory Function assessment;

Countries

China

Contacts

Public Contactxiong jiachuan

The Second Affiliated Hospital of Army Medical University (Xinqiao Hospital)

xiongjc@tmmu.edu.cn+86 186 9678 4882

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026