Efficacy and Safety of Qishen Yiqi Dropping Pills in Patients With Severe Pulmonary Hypertension

NCT07604805 | Recruiting DMC

• 1 other identifier: KY2023-707
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Idiopathic Pulmonary Hypertension

Keywords

idiopathic pulmonary arterial hypertension

Outcome Measures

Primary Outcomes (3)

• Change from Baseline in 6-Minute Walk Distance (6MWD) at 52 Weeks

  The 6-Minute Walk Test (6MWT) is a standardized, objective measure of functional exercise capacity commonly used in cardiovascular disease populations. Participants will be instructed to walk as far as possible on a flat, 30-meter long corridor for a total duration of 6 minutes, with the total distance covered (in meters) recorded as the 6-Minute Walk Distance (6MWD). The change in 6MWD from baseline to the end of the treatment period will be calculated as the primary efficacy endpoint, with a greater increase indicating better improvement in cardiopulmonary function and exercise tolerance.

  Baseline, 1 weeks, 8 weeks, 26 weeks，40weeks， 52weeks (end of treatment)

• Change from Baseline in Seattle Angina Questionnaire (SAQ) Score at 52 Weeks

  The Seattle Angina Questionnaire (SAQ) is a validated, disease-specific quality of life measure for patients with cardiovascular disease, covering 5 domains: physical limitation, angina stability, angina frequency, treatment satisfaction, and disease perception. Each domain score ranges from 0 to 100, with higher scores indicating better health status and less symptom burden. The change in total SAQ score from baseline to the end of follow-up will be calculated as the primary efficacy endpoint.

  Baseline, 1 weeks, 8 weeks, 26 weeks，40weeks， 52weeks (end of follow-up)

• Change from Baseline in Borg Rating of Perceived Exertion (RPE) Scale Score at 52 Weeks

  The Borg Rating of Perceived Exertion (RPE) Scale is a widely used, validated self-report measure of subjective exercise intensity and dyspnea in cardiovascular patient populations. The 6-20 point Borg Scale will be administered immediately after the 6-Minute Walk Test, where participants rate their perceived level of exertion ranging from 6 (no exertion at all) to 20 (maximal exertion). Lower scores indicate less perceived physical exertion and better exercise tolerance. The change in Borg RPE score from baseline to the end of treatment will be calculated as the primary efficacy endpoint.

  Baseline, 1 weeks, 8 weeks, 26 weeks，40weeks，52weeks (end of follow-up)

Secondary Outcomes (4)

• Change from Baseline in N-Terminal Pro-B-Type Natriuretic Peptide (NT-proBNP) Concentration at 52 Weeks

  Baseline, 1 weeks, 8 weeks, 26 weeks，40weeks， 52weeks (end of follow-up)

• Change from Baseline in WHO (NYHA) Functional Classification of Cardiac Status at 52 Weeks

  Baseline, 1 weeks, 8 weeks, 26 weeks，40weeks，52weeks (end of follow-up)

• Change from Baseline in Systolic Pulmonary Arterial Pressure (sPAP) Measured by Echocardiography at 12 Weeks

  Baseline, 1 weeks, 8 weeks, 26 weeks，40weeks，52weeks (end of follow-up)

• Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) in Participants Receiving Qishen Yiqi Dropping Pills Combined with Targeted Therapy versus Targeted Therapy Alone

  Baseline (within 7 days before treatment initiation), every 2 weeks during treatment, at the end of treatment (12 weeks), and 30 days after the last dose of study treatment (safety follow-up)

Study Arms (2)

Active Comparator: QSYQ Pills + targeted monotherapy group

EXPERIMENTAL

Patients in this arm will receive a 12-week period of Qishen Yiqi Dropping Pills 0.5g orally three times daily (tid) in combination with targeted monotherapy.

Drug: Qishen Yiqi Dropping Pills 0.5g Oral Three Times Daily + Targeted Therapy for Pulmonary Arterial Hypertension

Active Comparator: targeted monotherapy group

ACTIVE COMPARATOR

Patients in this arm will receive a 12-week period of targeted monotherapy.

Drug: Standard Pulmonary Arterial Hypertension (PAH)-Targeted Therapy Alone

Interventions

Qishen Yiqi Dropping Pills 0.5g Oral Three Times Daily + Targeted Therapy for Pulmonary Arterial Hypertension DRUG

Experimental Group: Qishen Yiqi Dropping Pills combined with standard PAH-targeted therapy. Qishen Yiqi Dropping Pills is an NMPA-approved Chinese patent medicine for cardiovascular diseases, each pill is 0.5g, main ingredients include astragalus membranaceus, salvia miltiorrhiza, panax notoginseng and dalbergia odorifera. Administration: 0.5g orally tid after meals. Targeted therapy follows \*2021 Chinese PAH Diagnosis and Treatment Guidelines\*, including one or more approved PAH-targeted agents at clinically recommended doses. Total treatment duration: 26weeks.

Active Comparator: QSYQ Pills + targeted monotherapy group

Standard Pulmonary Arterial Hypertension (PAH)-Targeted Therapy Alone DRUG

Control Group Intervention: Participants in this group receive standard pulmonary arterial hypertension (PAH)-targeted therapy alone, without additional Qishen Yiqi Dropping Pills. The targeted therapy regimen complies with the \*2021 Chinese Guidelines for the Diagnosis and Treatment of Pulmonary Hypertension\*, including one or more clinically approved PAH-targeted agents (endothelin receptor antagonists, phosphodiesterase type 5 inhibitors, or soluble guanylate cyclase stimulators) at standard recommended doses. The regimen is consistent with the participants' stable pre-enrollment treatment plan, or initiated per the protocol-specified dosing schedule, with no dose adjustment allowed during the study period unless required for safety reasons. The total treatment duration is 26 weeks, identical to the experimental group.

Active Comparator: targeted monotherapy group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Male or female participants aged between 18 and 75 years (inclusive) at the screening visit.
• \. 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.
• \. 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.
• \. 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.
• \. 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.
• \. 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.

You may not qualify if:

• \. Meet any of the following criteria: 2. Diagnosed with Group 3 or Group 5 pulmonary hypertension (PH) according to the \*2021 Chinese Guidelines for the Diagnosis and Treatment of Pulmonary Hypertension\*.
• \. Echocardiogram within 6 months before screening indicates left ventricular ejection fraction (LVEF) ≤ 40%, or clinically significant ischemic mitral or aortic valve disease, or constrictive heart disease as judged by the investigator.
• \. Presence of 3 or more of the following risk factors for left ventricular dysfunction:
• Body mass index (BMI) ≥ 30 kg/m² at screening visit
• History of essential hypertension
• Diabetes mellitus of any type
• History of significant coronary artery disease (CAD) confirmed by any of the following:
• History of myocardial infarction
• History of percutaneous coronary intervention (PCI)
• Angiographic evidence of ≥ 50% stenosis in at least one major coronary artery
• Positive cardiac stress imaging test
• History of coronary artery bypass graft surgery (CABG)
• History of chronic stable angina or unstable angina 5. Uncontrolled systemic arterial hypertension: systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg at randomization visit (Day 1).
• \. History of long QT syndrome or torsades de pointes ventricular tachycardia. 7. Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 3 times the upper limit of normal (ULN) at screening visit.
• \. Severe renal impairment: estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m² at screening calculated by the CKD-EPI formula.

Sponsors & Collaborators

• Guangdong Provincial People's Hospital: lead

Study Sites (1)

Guangdong Provincial People's Hospital

Guangzhou, Guagdong, 515000, China

RECRUITING

MeSH Terms

Conditions

Familial Primary Pulmonary Hypertension

Interventions

hydralazine 4-anisaldehyde hydrazone

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Xuyu He, MD, PhD

CONTACT

86136322737312; hexuyu97@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician

Study Record Dates

• First Submitted: May 18, 2026
• First Posted: May 22, 2026
• Study Start: October 25, 2023
• Primary Completion (Estimated): June 30, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)