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Efficacy and Safety of Compound Reserpine and Triamterene Tablets in the Treatment of Grade 1 Hypertension with Sympathetic Nervous System Excitation: A Prospective, Multicenter, Single-Arm Clinical Study

Efficacy and Safety of Compound Reserpine and Triamterene Tablets in the Treatment of Grade 1 Hypertension with Sympathetic Nervous System Excitation: A Prospective, Multicenter, Single-Arm Clinical Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500106977
Enrollment
Unknown
Registered
2025-08-01
Start date
2025-08-01
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Grade 1 Hypertension with Sympathetic Nervous System Overactivity

Interventions

Intervention Group:An 8-Week Treatment with Compound Reserpine and Triamterene Tablets in Patients with Grade 1 Hypertension and Sympathetic Nervous System Overactivity

Sponsors

Fuwai Hospital Chinese Academy of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Male or female subjects aged 18 years or older; 2.Diagnosed with grade 1 (mild) hypertension in accordance with the 2024 Chinese Guidelines for the Prevention and Treatment of Hypertension, without current use of antihypertensive medications; 3.Presence of sympathetic nervous system overactivity, defined by meeting either of the following combinations of diagnostic criteria: (1) Norepinephrine level > 3240 pmol/L; (2) SDNN 80 beats/min. Patients must meet criteria (1) + (2) or (1) + (3). 4.Fully understand the purpose of the study, be willing to participate, and sign the informed consent form (ICF)

Exclusion criteria

Exclusion criteria: 1.Patients with secondary hypertension; 2.Patients with a history of myocardial infarction, heart failure, unstable or stable angina, coronary artery bypass grafting (CABG), percutaneous coronary intervention (PCI), hypertensive encephalopathy, cerebrovascular accident, or transient ischemic attack (TIA); 3.Patients with severe arrhythmias, including atrial fibrillation, atrial flutter, pacemaker implantation, sinus bradycardia, or sick sinus syndrome; 4.Patients with type 1 diabetes or poorly controlled type 2 diabetes (HbA1c > 8.5%); 5.Patients with abnormal liver function (ALT, AST, or TBIL > 2.5 times the upper limit of normal); 6.Patients with severe renal insufficiency (eGFR 2000 mL); 9.Patients who frequently use sedatives, sleeping pills, or other addictive drugs, or have a history of drug or alcohol abuse within 6 months prior to screening; 10.Patients with a history of severe neurological or psychiatric disorders; 11.Patients who must take medications that may affect blood pressure, or have comorbid conditions that may interfere with the safety or efficacy evaluation of the study drug, or are at risk of serious drug interactions due to concomitant medications; 12.Patients with malignant tumors; 13.Pregnant, breastfeeding, planning to become pregnant, or unable to use contraception during the study period; 14.Patients who have participated in other clinical trials and taken investigational drugs within 3 months prior to screening; 15.Patients deemed by the investigator to have poor compliance or who are otherwise unsuitable for participation in this study.

Design outcomes

Primary

MeasureTime frame
Plasma Norepinephrine;

Secondary

MeasureTime frame
Heart Rate Variability (HRV) Parameters;Plasma Epinephrine Level;Resting Heart Rate (rHR) and Mean Heart Rate (HR);Average Seated and Office Blood Pressure;Vital Signs;

Countries

China

Contacts

Public ContactZengwu Wang

Fuwai Hospital Chinese Academy of Medical Sciences

wangzengwu@foxmail.com+86 136 0136 6932

Outcome results

None listed

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