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A study on the application value of single-pill combination in people with resistant hypertension

A study on the application value of single-pill combination in people with resistant hypertension

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100045735
Enrollment
Unknown
Registered
2021-04-23
Start date
2021-05-01
Completion date
Unknown
Last updated
2021-12-06

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

Conditions

resistant hypertension

Interventions

Sponsors

Department of Cardiology, the First Affiliated Hospital of China Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Sign and date any procedures prescribed by the study; 2.Male and female subjects; 3.Aged 18 years or above; 4.In the subject's medical records, there were clear medical records of at least 3 background antihypertensive medications received within 1 year prior to the screening visit but not controlled by blood pressure.Treated with at least 3 different pharmacological classes of antihypertensive drugs (including diuretics) for at least 4 weeks prior to screening. ß receptor blockers are not considered background antihypertensive drugs. 5.The average SiSBP measured by AOBP during screening visits was >=140mmHg. Or there is a clear record of a diagnosis of RHT in the subject's medical records; Or after switching from background antihypertensive drugs (i.e., at least 3 different pharmacological classes of drugs, including diuretics) to standardized background antihypertensive therapy, the mean valley value of SiSBP measured by AOBPM >=140mmHg; Or switch to standardized background antihypertensive therapy at least 4 weeks before the first RI visit, with an AOBPM measured SiSBP trough >=140mmHg.

Exclusion criteria

Exclusion criteria: 1.Subjects who are pregnant or nursing; 2.Epigenetic/False RHT due to white coat effect, medical inertia, poor treatment compliance, or secondary causes of hypertension (excluding obstructive sleep apnea); 3.Confirmed severe hypertension (grade 3); transient cerebral ischemic seizures, strokes, unstable angina or myocardial infarction (MI) are known and recorded within 6 months of screening; 4.Researchers believe there is clinically significant unstable heart disease, such as uncontrolled symptomatic arrhythmia, atrial fibrillation, NYHAIII or IV-grade congestive heart failure; 5.Severe renal insufficiency was defined as eGFR<15mL/min/1.73m^2 estimated using CKD epidemiology and creatinine equation; Type 1 DM; 6.The researchers believe that subjects may be put at risk, interfere with treatment compliance, study execution, or interpretation of any known factors, diseases, or clinically relevant internal or surgical conditions; 7.Any medication (e.g. psychiatric medication) that may affect BP.

Design outcomes

Primary

MeasureTime frame
Mean blood pressure (SBP) in the clinic from baseline to week 16 of treatment;

Secondary

MeasureTime frame
Changes in 24-hour mean SPB and DBP of ambulate blood pressure from baseline to week 12 of treatment;Mean SBP changes from baseline to week 12 in the clinic;Incidence of major adverse cardiovascular events, heart failure, malignant arrhythmias, and coronary events after percutaneous coronary intervention;Incidence of acute myocardial infarction;

Countries

China

Contacts

Public ContactLi Zhao

The First Affiliated Hospital of China Medical University

lizhao@cmu.edu.cn+86 13504012021

Outcome results

None listed

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