Standardized Antihypertensive Treatment Protocol

NCT06790927 | Not Yet Recruiting

• 1 other identifier: Standardized Protocol
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

Study name: A cluster randomized controlled trial on a standardized antihypertensive treatment protocol. Objective: To evaluate a simple treatment protocol for China in a real clinic setting. Study design: In this study, newly identified uncontrolled hypertension or monotherapy for patients with substandard blood pressure are sequentially enrolled and monitored for blood pressure in the office and at home. Randomization was carried out on a machine numeric table, one center with a small value assigned to the usual care group and one with a larger number was assigned to the standard treatment group. Study population: Men and Women aged 18-80 years (n=400) meeting the inclusion/exclusion criteria. Randomization and treatment: Randomization was carried out on a machine numeric table, one center with a small value assigned to the usual care group and one with a larger number was assigned to the standard treatment group. In the usual treatment group, the doctor prescribes medication for patients, and advise the patient to take the medication on time and follow-up every 3 months. The standard treatment group was followed up monthly, Amlodipine 5 mg is preferred for selected patients, and amlodipine 5 mg + irbesartan 150mg is used for those who do not meet blood pressure targets after 4 weeks of treatment, aftre one month amlodipine 10mg + irbesartan 300mg is used for those who do not meet blood pressure targets, for those whose blood pressure is still not up to standard after 4 weeks will be treated with amlodipine 10mg + irbesartan 300mg + hydrochlorothiazide 12.5mg. Follow up: 6 months. Sample size: a total of 400 patients should be enrolled in the combination. Timeline: After obtaining the approval of Ethics Committee of Ruijin Hospital in November 2024, Patients enrollment will be performed between Feburary 2025 to Feburary 2026.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• Control rate of clinical blood pressure

  6 months

Secondary Outcomes (2)

• Control rate of home blood pressure

  6 months

• The rate at which doctor prescribe according to standard treatment protocol

  6 months

Study Arms (2)

usual treatment group

ACTIVE COMPARATOR

Drug: Usual Care

standard treatment group

EXPERIMENTAL

Drug: Standard Medical Therapy

Interventions

Usual Care DRUG

The doctor prescribes medication for patients and follow-up every 3 months

usual treatment group

Standard Medical Therapy DRUG

The standard treatment group was followed up monthly, Amlodipine 5 mg is preferred for selected patients, and amlodipine 5 mg + irbesartan 150mg is used for those who do not meet blood pressure targets after 4 weeks treatment, amlodipine 10mg + irbesartan 300mg is used for those who do not meet blood pressure targets after one month, for those whose blood pressure is still not up to standard after 4 weeks will be treated with amlodipine 10mg + irbesartan 300mg + hydrochlorothiazide 12.5mg.

standard treatment group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-80 years;
• Newly identified or monotherapy patients with uncontrolled clinical blood pressure;
• Systolic blood pressure≥140 mmHg and/or diastolic blood pressure≥90 mmHg;
• Agree to participate in the trial and sign the informed consent form.

You may not qualify if:

• The arm circumference is too large or too small (\<17cm or \>42cm) ;
• suspected or definite secondary hypertension;
• Combined with eGFR \< 30 ml/min/1.73m2 or end-stage renal disease;
• Cardiovascular and cerebrovascular events have occurred in the past 3 months, such as myocardial infarction, stroke, acute heart failure, causes Unstable angina pectoris, hospitalization or revascularization of coronary artery disease or bypass graft surgery;
• Combined with liver damage: aspartate aminotransferase \[AST\] or alanine aminotransferase \[ALT\] or total bilirubin at 2 times or more of the upper limit of normal;
• Concomitant physical diseases with survival expectations of less than 3 years, or tumors diagnosed in the past 2 years and requiring treatment;
• The investigator assessed that participation in the study was unfavorable to the subject.

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead
• Vital Strategies: collaborator

Study Sites (1)

Shanghai Institute of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, China, 200025, China

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Prof.Wang

CONTACT

8613764189476; jiguangw@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Model Details: Eligible patients will be divided into two groups. In the usual treatment group, the doctor prescribes medication for patients, and advise the patient to take the medication on time and follow-up every 3 months. The standard treatment group was followed up monthly, Amlodipine 5 mg is preferred for selected patients, and amlodipine 5 mg + irbesartan 150mg is used for those who do not meet blood pressure targets after 4 weeks treatment, amlodipine 10mg + irbesartan 300mg is used for those who do not meet blood pressure targets after one month, for those whose blood pressure is still not up to standard after 4 weeks will be treated with amlodipine 10mg + irbesartan 300mg + hydrochlorothiazide 12.5mg

Study Record Dates

• First Submitted: January 14, 2025
• First Posted: January 24, 2025
• Study Start: February 24, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 24, 2025

Record last verified: 2025-01

Locations

CN (1)