Primary AldosteronismNCT04020783
Primary Aldosteronism: Prospective Screening Registry in China
An observational study of Primary Aldosteronism, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
1. Study name: A prospective study of the incidence and outcomes of Primary aldosteronism in Chinese hypertensive patients 2. Rationale: Unlike essential hypertension, secondary hypertension is caused by certain defined diseases or causes. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Primary Aldosteronism
- How many people
- 10,000 participants
- Where
- 1 siteChina
- Study dates
- 18 Jul 2018to Dec 2024
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hypertensive patients with high suspected or confirmed of PA. High suspected of PA 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 PA; 6) hypertension with obstructive respiratory sleep apnea. The other study population is the PA patients confirmed.
Who may be able to join
None listed.
Who cannot join
- Not eligible for inclusion or in situations considered unqualified for the study by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Institite of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, 200025
Jiguang Wang, MD, PhD, 86-21-64370045 ext. 610911, jiguang_wang_jgw@yahoo.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Primary Aldosteronism
- Being tested
- NO Intervention
- Keywords
- Primary aldosteronism, Screening
- Medical subject headings
- Hyperaldosteronism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NO InterventionOther
NO Intervention
| Study group | Role | What they receive |
|---|---|---|
| Observation group | sequential Receives: Other: NO Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
ARR positive rate
ARR positive rate in the high suspicion of PA.
Measured: 1 day
PA confirmed diagnostic rate
The rate of PA confirmed diagnosis in highly suspected PA population.
Measured: 1 month
The change of office blood pressure
Comparison of blood pressure between baseline and 6/12/24 months.
Measured: 24 months
The rate of incidence of cardiovascular events
The rate of incidence of cardiovascular events in the PA patients,such as cerebral infarction, hypertensive nephropathy, myocardial infarction and so on.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2019
- Study start18 Jul 2018
- Primary completionOct 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary AldosteronismStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji-Guang Wang, Shanghai Jiao Tong University School of Medicine
- Investigators
- Jiguang Wang, MD, PhD, Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04020783
- Sponsor's protocol ID
- Chinapaps
- Status last verified
- Aug 2024
- First submitted
- 26 Jun 2019
- Last updated
- 13 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hu Z, Chen X, Cheng YB, Zhong P, Li QA, Zhao Y, Luan H, Ren J, Chen GL, Wang JG. Clinical characteristics of primary aldosteronism screened from Chinese patients with hypertension: The China primary aldosteronism prospective study. J Clin Hypertens (Greenwich). 2024 Sep;26(9):1082-1089. doi: 10.1111/jch.14874. Epub 2024 Jul 22.
PubMed 39037171
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of the Incidence and Outcomes of Primary Aldosteronism in Chinese Hypertensive Patients
- ClinicalTrials.gov ID
- NCT04020783
- Acronym / sponsor ID
- Chinapaps
- Conditions
- Primary Aldosteronism
- Keywords
- Primary aldosteronism, Screening
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 18 Jul 2018 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 16 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observation group | – | Other: NO Interventionsequential |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hypertensive patients with high suspected or confirmed of PA. High suspected of PA 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 PA; 6) hypertension with obstructive respiratory sleep apnea. The other study population is the PA patients confirmed.
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Not eligible for inclusion or in situations considered unqualified for the study by the investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NO InterventionNO Intervention | Other | Observation group |
Primary outcome
ARR positive rate
Time frame: 1 day
ARR positive rate in the high suspicion of PA.
PA confirmed diagnostic rate
Time frame: 1 month
The rate of PA confirmed diagnosis in highly suspected PA population.
The change of office blood pressure
Time frame: 24 months
Comparison of blood pressure between baseline and 6/12/24 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
- Derived from this study: PubMed 39037171Hu Z, Chen X, Cheng YB, Zhong P, Li QA, Zhao Y, Luan H, Ren J, Chen GL, Wang JG. Clinical characteristics of primary aldosteronism screened from Chinese patients with hypertension: The China primary aldosteronism prospective study. J Clin Hypertens (Greenwich). 2024 Sep;26(9):1082-1089. doi: 10.1111/jch.14874. Epub 2024 Jul 22.
- Individual participant dataSharing planned: Undecided
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Primary Aldosteronism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jiguang Wang, MD, PhD principal investigator
Ruijin Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Aldosteronism, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiguang Wang, MD, PhD (+86-21-64370045 ext. 610911, jiguangw@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ARR positive rate (time frame: 1 day). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04020783, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2024.