Efficacy and Safety of Qishen Yiqi Dropping Pills in Patients With Severe Pulmonary Hypertension: A Prospective, Randomized Controlled Trial
This study aims to compare the effectiveness and safety of two treatment approaches for patients with severe pulmonary hypertension: standard targeted drug therapy alone, and a combination of standard targeted drugs plus Qishen Yiqi Dropping Pills over 52 weeks of treatment. Pulmonary hypertension is a chronic condition that raises blood pressure in the lung arteries, causing symptoms like shortness of breath, tiredness, and difficulty with physical activity. While targeted drug treatments are available, many patients still experience persistent symptoms and reduced quality of life. This study will enroll patients with severe pulmonary hypertension to see if adding Qishen Yiqi Dropping Pills to standard treatment can improve patient outcomes. Participants will be randomly assigned to one of two groups: the combination treatment group will receive Qishen Yiqi Dropping Pills plus standard targeted drugs, and the control group will receive standard targeted drugs alone. All participants will be followed for 52 weeks, during which we will regularly assess: * Changes in daily quality of life * How far participants can walk in 6 minutes, and their level of breathlessness after the walk * Changes in heart function and related blood test indicators * Any side effects or discomfort during treatment The primary goal of this study is to see if the combination treatment can improve patients' exercise capacity and quality of life more effectively than standard treatment alone. We will also monitor the safety of adding Qishen Yiqi Dropping Pills to standard therapy. All study procedures follow ethical regulations, and participants can withdraw from the study at any time without affecting their regular medical care.
• 1\. Male or female participants aged between 18 and 75 years (inclusive) at the screening visit.
• 2\. Diagnosed with pulmonary arterial hypertension (PAH) classified according to the \*2021 Chinese Guidelines for the Diagnosis and Treatment of Pulmonary Hypertension\*, and belonging to one of the following subgroups:
• Subgroup Ⅰ: Idiopathic pulmonary arterial hypertension (IPAH) under the category of arterial pulmonary hypertension
• Subgroup Ⅱ: Pulmonary hypertension secondary to left heart disease (congenital heart disease) 3. World Health Organization (WHO) Functional Class III or IV symptoms at screening.
• 4\. Meet all of the following hemodynamic criteria confirmed by right heart catheterization (RHC) at study screening: mean pulmonary arterial pressure (mPAP) ≥ 25 mmHg and pulmonary capillary wedge pressure (PCWP) ≤ 15 mmHg.
• 5\. Able to walk a minimum of 100 meters and a maximum of 440 meters during the 6-Minute Walk Test (6MWT) at the screening visit; in addition, participants must demonstrate stable baseline 6MWT performance between the screening visit and the randomization visit.
• 6\. Participants with pulmonary hypertension who are either treatment-naïve or currently receiving treatment: for participants who have received prior treatment (defined as having used PAH-targeted therapeutic agents within 4 weeks before screening), mPAP ≥ 25 mmHg and PCWP ≤ 15 mmHg must be confirmed at the randomization visit.
• 7\. Able to understand study procedures, willing to comply with study restrictions, and willing and able to provide written informed consent prior to the initiation of all study-related procedures.