Actively Recruiting
Comparison of Sequential to Initial Combination Therapy in PAH
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2025-07-29
376
Participants Needed
1
Research Sites
185 weeks
Total Duration
On this page
Sponsors
S
Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead Sponsor
H
Huzhou Central Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a multicenter, randomized, controlled, double-blind, and non-inferiority clinical trial to compare the efficacy of sequential to initial combination therapy in patients with pulmonary arterial hypertension (PAH). Ambrisentan and Tadalafil will be used in the study. Our research hypothesis is that the efficacy of sequential combination therapy in PAH patients is not inferior to the initial combination therapy as the primary efficacy endpoint is the change in 6MWD at month 12 from baseline.
CONDITIONS
Official Title
Comparison of Sequential to Initial Combination Therapy in PAH
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 to 80 years and weight at least 40 kg
- WHO functional classification I-III
- Diagnosed with PAH caused by idiopathic PAH, hereditary PAH, or associated PAH including connective tissue diseases, drug/toxin exposure, or corrected congenital heart diseases over 1 year
- Risk stratification assessed as low-risk or intermediate-risk according to the 2022 ESC/ERS guidelines
- Right heart catheterization with mean pulmonary artery pressure ≥ 25 mmHg, pulmonary vascular resistance ≥ 3 Wood units, PAWP ≤ 15 mmHg, and cardiac output measured by thermal dilution or direct Fick method
- Pulmonary function tests with total lung capacity ≥ 60%, FEV1 ≥ 55%, and DLCO_SB ≥ 40% of predicted normal
- Baseline 6MWD over 100 meters repeated twice at screening with values within 15% of each other
- Resting arterial oxygen saturation (SaO2) ≥ 88% without supplemental oxygen
- No cardiopulmonary rehabilitation training within 12 weeks prior to screening
- Females of childbearing potential must agree to use contraception until study end
- No participation in other clinical studies involving investigational drugs or devices during the study
- Ability to understand and sign informed consent form
You will not qualify if you...
- Other types of PAH such as HIV-related, schistosomiasis-related, portal hypertension-associated, pulmonary vein occlusive disease, or pulmonary capillary hemangiomatosis
- Group 4, 2, 3, or 5 pulmonary hypertension
- Use of PAH therapy (PDE5 inhibitors, ERAs, prostacyclin) within 4 weeks prior to screening
- Prior intolerance to ERA or PDE5 inhibitors unrelated to liver dysfunction
- Known allergy to study drugs or their components
- Use of intravenous inotropes within 2 weeks prior to screening
- Use of protease inhibitors, systemic ketoconazole, itraconazole, or strong CYP3A4 inducers
- Unstable doses of calcium channel blockers or statins within 4 weeks prior to screening
- History of angina or nitrate treatment within 12 weeks prior to screening
- Laboratory values with ALT or AST over twice the upper limit, bilirubin over 1.5 times upper limit, or severe renal impairment
- Severe liver dysfunction (Child-Pugh Class C)
- Significant anemia, bleeding disorders, or active peptic ulcers
- Uncontrolled hypertension (≥180/110 mmHg) or severe hypotension (<90/50 mmHg)
- Recent myocardial infarction within 3 months
- Significant cardiac diseases including valve disease, cardiomyopathies, arrhythmias, or coronary artery disease
- History of non-arteritic anterior ischemic optic neuropathy or hereditary degenerative retinal disease
- Significant fluid retention
- Other serious diseases affecting safety or study efficacy
- History of cancer within 5 years except certain non-metastatic cases
- Pregnant or breastfeeding females
- Poor compliance history
- Alcohol or drug abuse within 1 year
- Participation in other investigational studies within 4 weeks prior to screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310058
Actively Recruiting
Research Team
Z
Zongye Cai, MD, PhD
CONTACT
Z
Zexin Chen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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