- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04020783
Primary Aldosteronism: Prospective Screening Registry in China
A Prospective Study of the Incidence and Outcomes of Primary Aldosteronism in Chinese Hypertensive Patients
- Study name: A prospective study of the incidence and outcomes of Primary aldosteronism in Chinese hypertensive patients
- Rationale: Unlike essential hypertension, secondary hypertension is caused by certain defined diseases or causes. For this reason, secondary hypertension can often be cured or effectively controlled. As one of the most common types of secondary hypertension, it is estimated that primary aldosteronism (PA) accounts for 5%-10% of all hypertensive patients, accounting for about 20% of patients with refractory hypertension.
- Objective: 1) Collect and analyze the population and disease characteristics of Chinese PA patients; 2) Strengthen the awareness of screening for PA in people with high blood pressure.
- Study design: Prospective , multi-center, observational study.
- Study population: Hypertensive patients with high suspected or confirmed of primary aldosteronism.
- Treatment: Standardized diagnosis and treatment procedure as recommended in the international guidelines of PA.
- Follow up: 6, 12 and 24 months after diagnosis.
- Sample size estimation: About 10 thousand.
- Timeline: Start of subjects enrollment: July 2019; End of subjects enrollment: December 2022; End of study: December 2024.
- Organization: The Centre for Epidemiological Studies and Clinical Trials, Ruijin Hospital, Shanghai, China.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
- Study name: A prospective study of the incidence and outcomes of Primary aldosteronism in Chinese hypertensive patients
Rationale: Hypertension is the most common cardiovascular disease, a serious cardiovascular disease state, and the most important risk factor for serious cardiovascular and cerebrovascular complications such as stroke, myocardial infarction, heart failure, and renal insufficiency. The China Cardiovascular Disease Report 2018 pointed out that the total number of people suffering from hypertension in China reached 245 million, which has become a major public health problem affecting people's health and restricting economic development.
Unlike essential hypertension, secondary hypertension is caused by certain defined diseases or causes. For this reason, secondary hypertension can often be cured or effectively controlled with the appropriate treatment. As one of the most common types of secondary hypertension, it is estimated that primary aldosteronism (PA) accounts for 5%-10% of all hypertensive patients, accounting for about 20% of patients with refractory hypertension. Therefore, how to find out patients with PA in hypertensive population in time and carry out targeted treatment is a challenge that cardiovascular professional clinicians must face.
Diagnostic PA begins with screening. With the advancement of detection technology, especially the clinical popularity of chemiluminescence detection of plasma aldosterone and renin concentration, the detection of suspected PA patients by plasma aldosterone renin ratio (ARR) in medium-sized hospitals has become a reality. Due to the limitations of clinical examination, there are only a few hospitals that can actually perform the etiological diagnosis of PA. As long as we can screen out suspected PA patients, it is a major advancement in the diagnosis and treatment of secondary hypertension. In order to popularize the clinical application of PA screening and diagnosis technology, systematically collect clinical data of PA patients in China, it is necessary to carry out PA screening registration research in hypertensive patients.
- Objective: 1) Collect and analyze the population and disease characteristics of Chinese PA patients; 2) Strengthen the awareness of screening for PA in people with high blood pressure.
- Study design: Prospective, multi-center observational study.
- Study population: Hypertensive patients with high suspected or confirmed of primary aldosteronism. High suspected of primary aldosteronism include 6 types of hypertensive patients: 1) persistent blood pressure > 160/100 mmHg, refractory hypertension ( combined with 3 antihypertensive drugs, including diuretics, blood pressure > 140/90 mmHg), Combined use of 4 or more antihypertensive drugs, blood pressure <140/90 mmHg; 2) hypertension combined with spontaneous or diuretic hypokalemia; 3) hypertension with adrenalaccidental tumor; 4) family history of early onset hypertension Or hypertensive patients with a family history of cerebrovascular accidents (<40 years old); 5) first-degree relatives with hypertension in patients with primary aldosteronism; 6) hypertension with obstructive respiratory sleep apnea. The other study population is the PA patients confirmed.
- Treatment: Standardized diagnosis and treatment procedure as recommended in the international guidelines of PA. Hypertensive Patients should adjust antihypertensive medication before ARR testing to ensure accurate ARR measurements. Patients with positive ARR results (more than 40) are suspected PA and need confirmation test, such as Saline infusion test or Captopril test. PA patients should undergo a sub-type diagnosis, such as adrenal CT, AVS. Patients with PA confirmed are treated with drugs or surgery after diagnosis.
- Follow up: 6, 12 and 24 months after diagnosis.
- Sample size estimation: About 10 thousand.
- Timeline: Start of subjects enrollment: July 2019; End of subjects enrollment: December 2022; End of study: December 2024.
- Organization: The Centre for Epidemiological Studies and Clinical Trials, Ruijin Hospital, Shanghai, China.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
-
Shanghai, China, 200025
- Shanghai Institite of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Eligibility criteria
- Age: more than or equal to 18 years old;
- Hypertensive patients ;
- ARR > 40;
- Informed consent;
Exclusion criteria:
Not eligible for inclusion or in situations considered unqualified for the study by the investigator.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Observation group
sequential
|
NO Intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ARR positive rate
Time Frame: 1 day
|
ARR positive rate in the high suspicion of PA.
|
1 day
|
PA confirmed diagnostic rate
Time Frame: 1 month
|
The rate of PA confirmed diagnosis in highly suspected PA population.
|
1 month
|
The change of office blood pressure
Time Frame: 24 months
|
Comparison of blood pressure between baseline and 6/12/24 months.
|
24 months
|
The rate of incidence of cardiovascular events
Time Frame: 24 months
|
The rate of incidence of cardiovascular events in the PA patients,such as cerebral infarction, hypertensive nephropathy, myocardial infarction and so on.
|
24 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jiguang Wang, MD, PhD, Shanghai Jiao Tong University School of Medicine Ruijin Hospital
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Chinapaps
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Primary Aldosteronism
-
Radboud University Medical CenterCompletedPrimary Aldosteronism | Primary HyperaldosteronismNetherlands
-
Shanghai Jiao Tong University School of MedicineNot yet recruitingPrimary AldosteronismChina
-
University of CalgaryNot yet recruiting
-
Queen Mary University of LondonRecruiting
-
First Affiliated Hospital of Chengdu Medical CollegeNot yet recruitingPrimary AldosteronismChina
-
University College London HospitalsCompletedPrimary Aldosteronism
-
Shanghai Zhongshan HospitalCompleted
-
Qifu LiWest China Hospital; Tongji Hospital; Second Affiliated Hospital, School of Medicine... and other collaboratorsRecruitingPrimary AldosteronismChina
-
Xiao ChenRecruitingPrimary AldosteronismChina
-
Liverpool University Hospitals NHS Foundation TrustRecruiting
Clinical Trials on NO Intervention
-
Wave NeuroscienceCompletedAutistic DisorderUnited States
-
University of Alabama at BirminghamCompletedInflammatory Bowel Diseases | Colorectal Cancer | Diverticular Diseases | Social BehaviorUnited States
-
Janssen Research & Development, LLCCompletedLupus Erythematosus, Systemic | Lupus Erythematosus, Cutaneous | Lupus Erythematosus, DiscoidUnited States, Poland
-
Hospital Universitario La Paz3MVX CCB and Agaplesion Markus Krankenhaus, Frankfurt a.M., Germany.; Department...RecruitingEmbolism | Atrial Fibrillation | Arrhythmia | Stroke, Acute | Stroke Sequelae | AblationSpain
-
Southern California College of Optometry at Marshall...Ohio State University; University of Houston; Alcon Research; University of Waterloo and other collaboratorsCompletedContact Lens Complication | Contact Lens Acute Red Eye | Contact Lens Related Corneal Infiltrate (Disorder) | Contact Lens-Induced Corneal Fluorescein StainingUnited States, Canada
-
University of Dublin, Trinity CollegeCompleted
-
Hôpital Necker-Enfants MaladesUnknown
-
China Medical University HospitalUnknownIntention to Stay, Turnover Behavior
-
Wright State UniversityCompleted