4006-776-356 出国就医服务电话

免费获得国外相关药品,最快 1 个工作日回馈药物信息

出境医 / 临床实验 / Primary Aldosteronism: Prospective Screening Registry in China

Primary Aldosteronism: Prospective Screening Registry in China

Study Description
Brief 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. 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.
  3. 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.
  4. Study design: Prospective , multi-center, observational study.
  5. Study population: Hypertensive patients with high suspected or confirmed of primary aldosteronism.
  6. Treatment: Standardized diagnosis and treatment procedure as recommended in the international guidelines of PA.
  7. Follow up: 6, 12 and 24 months after diagnosis.
  8. Sample size estimation: About 10 thousand.
  9. Timeline: Start of subjects enrollment: July 2019; End of subjects enrollment: December 2022; End of study: December 2024.
  10. Organization: The Centre for Epidemiological Studies and Clinical Trials, Ruijin Hospital, Shanghai, China.

Condition or disease Intervention/treatment
Primary Aldosteronism Other: NO Intervention

Detailed Description:
  1. Study name: A prospective study of the incidence and outcomes of Primary aldosteronism in Chinese hypertensive patients
  2. 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.

  3. 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.
  4. Study design: Prospective, multi-center observational study.
  5. 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.
  6. 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.
  7. Follow up: 6, 12 and 24 months after diagnosis.
  8. Sample size estimation: About 10 thousand.
  9. Timeline: Start of subjects enrollment: July 2019; End of subjects enrollment: December 2022; End of study: December 2024.
  10. Organization: The Centre for Epidemiological Studies and Clinical Trials, Ruijin Hospital, Shanghai, China.
Study Design
Layout table for study information
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
Arms and Interventions
Group/Cohort Intervention/treatment
Observation group
sequential
Other: NO Intervention
NO Intervention

Outcome Measures
Primary Outcome Measures :
  1. ARR positive rate [ Time Frame: 1 day ]
    ARR positive rate in the high suspicion of PA.

  2. PA confirmed diagnostic rate [ Time Frame: 1 month ]
    The rate of PA confirmed diagnosis in highly suspected PA population.

  3. The change of office blood pressure [ Time Frame: 24 months ]
    Comparison of blood pressure between baseline and 6/12/24 months.

  4. 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.


Eligibility Criteria
Layout table for eligibility information
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
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.
Criteria

Eligibility criteria

  1. Age: more than or equal to 18 years old;
  2. Hypertensive patients ;
  3. ARR > 40;
  4. Informed consent;

Exclusion criteria:

Not eligible for inclusion or in situations considered unqualified for the study by the investigator.

Contacts and Locations

Contacts
Layout table for location contacts
Contact: Jiguang Wang, MD, PhD +86-21-64370045 ext 610911 jiguangw@163.com

Locations
Layout table for location information
China
Shanghai Institite of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, China, 200025
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Investigators
Layout table for investigator information
Principal Investigator: Jiguang Wang, MD, PhD Shanghai Jiao Tong University School of Medicine Ruijin Hospital
Tracking Information
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
 (submitted: July 15, 2019)
  • 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.
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
  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. 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.
  3. 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.
  4. Study design: Prospective , multi-center, observational study.
  5. Study population: Hypertensive patients with high suspected or confirmed of primary aldosteronism.
  6. Treatment: Standardized diagnosis and treatment procedure as recommended in the international guidelines of PA.
  7. Follow up: 6, 12 and 24 months after diagnosis.
  8. Sample size estimation: About 10 thousand.
  9. Timeline: Start of subjects enrollment: July 2019; End of subjects enrollment: December 2022; End of study: December 2024.
  10. Organization: The Centre for Epidemiological Studies and Clinical Trials, Ruijin Hospital, Shanghai, China.
Detailed Description
  1. Study name: A prospective study of the incidence and outcomes of Primary aldosteronism in Chinese hypertensive patients
  2. 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.

  3. 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.
  4. Study design: Prospective, multi-center observational study.
  5. 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.
  6. 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.
  7. Follow up: 6, 12 and 24 months after diagnosis.
  8. Sample size estimation: About 10 thousand.
  9. Timeline: Start of subjects enrollment: July 2019; End of subjects enrollment: December 2022; End of study: December 2024.
  10. Organization: The Centre for Epidemiological Studies and Clinical Trials, Ruijin Hospital, Shanghai, China.
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
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
Study Groups/Cohorts Observation group
sequential
Intervention: Other: NO Intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: July 15, 2019)
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

  1. Age: more than or equal to 18 years old;
  2. Hypertensive patients ;
  3. ARR > 40;
  4. Informed consent;

Exclusion criteria:

Not eligible for inclusion or in situations considered unqualified for the study by the investigator.

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Jiguang Wang, MD, PhD +86-21-64370045 ext 610911 jiguangw@163.com
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
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
Principal Investigator: Jiguang Wang, MD, PhD Shanghai Jiao Tong University School of Medicine Ruijin Hospital
PRS Account Shanghai Jiao Tong University School of Medicine
Verification Date March 2021