NCT06790927Not yet recruiting
Standardized Antihypertensive Treatment Protocol
A Cluster Randomized Controlled Trial on a Standardized Antihypertensive Treatment Protocol
Source: ClinicalTrials.gov · Last updated 24 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 400 (estimated)
- First submitted
- 14 Jan 2025
- Start date
- 24 Feb 2025
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Diseases
- High blood pressure
- NCT number
- NCT06790927
What you commit to
- Study type: Interventional
- Planned participants: 400
- From 24 Feb 2025 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant physical diseases with survival expectations of less than 3 years, or tumors diagnosed in the past 2 years and requiring treatment;
Other illness
- suspected or definite secondary hypertension;
- 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;
Lab values
- Combined with eGFR \< 30 ml/min/1.73m2 or end-stage renal disease;
- 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;
Other
- The arm circumference is too large or too small (\<17cm or \>42cm) ;
- The investigator assessed that participation in the study was unfavorable to the subject.
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai Institute of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.