Condition or disease | Intervention/treatment |
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Primary Aldosteronism | Other: NO Intervention |
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.
Study Type : | Observational [Patient Registry] |
Estimated Enrollment : | 10000 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Target Follow-Up Duration: | 24 Months |
Official Title: | A Prospective Study of the Incidence and Outcomes of Primary Aldosteronism in Chinese Hypertensive Patients |
Estimated Study Start Date : | March 2021 |
Estimated Primary Completion Date : | December 2022 |
Estimated Study Completion Date : | December 2024 |
Group/Cohort | Intervention/treatment |
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Observation group
sequential
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Other: NO Intervention
NO Intervention
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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Eligibility criteria
Exclusion criteria:
Not eligible for inclusion or in situations considered unqualified for the study by the investigator.
Contact: Jiguang Wang, MD, PhD | +86-21-64370045 ext 610911 | jiguangw@163.com |
China | |
Shanghai Institite of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine | |
Shanghai, China, 200025 |
Principal Investigator: | Jiguang Wang, MD, PhD | Shanghai Jiao Tong University School of Medicine Ruijin Hospital |
Tracking Information | |||||
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First Submitted Date | June 26, 2019 | ||||
First Posted Date | July 16, 2019 | ||||
Last Update Posted Date | March 17, 2021 | ||||
Estimated Study Start Date | March 2021 | ||||
Estimated Primary Completion Date | December 2022 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
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Original Primary Outcome Measures | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures | Not Provided | ||||
Original Secondary Outcome Measures | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | Primary Aldosteronism: Prospective Screening Registry in China | ||||
Official Title | A Prospective Study of the Incidence and Outcomes of Primary Aldosteronism in Chinese Hypertensive Patients | ||||
Brief Summary |
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Detailed Description |
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Study Type | Observational [Patient Registry] | ||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | 24 Months | ||||
Biospecimen | Not Provided | ||||
Sampling Method | Non-Probability Sample | ||||
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. | ||||
Condition | Primary Aldosteronism | ||||
Intervention | Other: NO Intervention
NO Intervention
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Study Groups/Cohorts | Observation group
sequential
Intervention: Other: NO Intervention
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Not yet recruiting | ||||
Estimated Enrollment |
10000 | ||||
Original Estimated Enrollment | Same as current | ||||
Estimated Study Completion Date | December 2024 | ||||
Estimated Primary Completion Date | December 2022 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria |
Eligibility criteria
Exclusion criteria: Not eligible for inclusion or in situations considered unqualified for the study by the investigator. |
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Sex/Gender |
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Ages | 18 Years to 65 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts |
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Listed Location Countries | China | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT04020783 | ||||
Other Study ID Numbers | Chinapaps | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Responsible Party | Ji-Guang Wang, Shanghai Jiao Tong University School of Medicine | ||||
Study Sponsor | Shanghai Jiao Tong University School of Medicine | ||||
Collaborators | Not Provided | ||||
Investigators |
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PRS Account | Shanghai Jiao Tong University School of Medicine | ||||
Verification Date | March 2021 |