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Trial record 70 of 221 for:    Aldosterone

Primary Aldosteronism In Hypertensive Patients in China (PA-China)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03155139
Recruitment Status : Completed
First Posted : May 16, 2017
Last Update Posted : January 31, 2019
Sponsor:
Collaborator:
Fu Wai Hospital, Beijing, China
Information provided by (Responsible Party):
Qifu Li, Chongqing Medical University

Brief Summary:
To investigate the prevalence of primary aldosteronism (PA) in Chinese patients with hypertension.

Condition or disease Intervention/treatment
Hyperaldosteronism; Primary Hypertension Secondary Diagnostic Test: Aldosterone/renin ratio (ARR) testing Diagnostic Test: Confirmatory tests

Detailed Description:
This is a nationwide sampling study. To investigate the prevalence of primary aldosteronism (PA) in Chinese patients with hypertension, we will conduct a case detection of PA in Chinese hypertensive patients from 10 centers of China (including Beijing, Chongqing, Shanghai, Guangzhou, et al.); furthermore, a case confirmation of PA (captopril challenge test and saline infusion test) will be performed if the result of case detection is positive. This study will be completed in two years.

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Study Type : Observational
Actual Enrollment : 3500 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Primary Aldosteronism In Hypertensive Patients in China
Actual Study Start Date : June 3, 2017
Actual Primary Completion Date : November 30, 2018
Actual Study Completion Date : November 30, 2018


Group/Cohort Intervention/treatment
Patients without primary aldosteronism (PA)
PA case detection or confirmatory tests was negative.
Diagnostic Test: Aldosterone/renin ratio (ARR) testing
Plasma aldosterone concentration tests, Direct renin concentration tests

Patients with primary aldosteronism (PA)
PA case detection and confirmatory tests were positive.
Diagnostic Test: Aldosterone/renin ratio (ARR) testing
Plasma aldosterone concentration tests, Direct renin concentration tests

Diagnostic Test: Confirmatory tests
Captopril challenge test, Saline infusion test




Primary Outcome Measures :
  1. Number of subjects with newly diagnosed hypertension [ Time Frame: 2 years ]
    To calculate the prevalence of PA in Chinese patients with hypertension

  2. Number of subjects with confirmed primary aldosteronism (PA) [ Time Frame: 2 years ]
    To calculate the prevalence of PA in Chinese patients with hypertension

  3. Prevalence of PA [ Time Frame: 2 years ]
    Prevalence of PA= Number of PA / Number of subjects with hypertension


Secondary Outcome Measures :
  1. Age [ Time Frame: 2 years ]
    Characteristics of PA in Chinese patients with hypertension

  2. Blood pressure [ Time Frame: 2 years ]
    Characteristics of PA in Chinese patients with hypertension

  3. Family history of hypertension [ Time Frame: 2 years ]
    Characteristics of PA in Chinese patients with hypertension

  4. Fasting blood glucose [ Time Frame: 2 years ]
    Characteristics of PA in Chinese patients with hypertension

  5. Cardiovascular events [ Time Frame: 2 years ]
    Characteristics of PA in Chinese patients with hypertension


Biospecimen Retention:   Samples With DNA
Some subtye of PA such as glucocorticoid remediable aldosteronism(GRA) should be diagnosed by DNA


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Sampling Design: hypertensive patients will be continuously sampled for case detection in each center. PASS 11.0 Software-Confidence Intervals for One Proportion was used to calculate the sample size. A sample size of 2928 produces a two-sided 95% confidence interval with a width equal to 0.02 when the sample proportion(prevalence of PA) is 0.080. Accounting for the 20% withdraw rate in the process of case detection, the final sample size should be 3635 (about 4000 cases).
Criteria

Inclusion Criteria:

  1. Newly diagnosed hypertension(with a course less than six months);
  2. Drug negative, or voluntary to discontinue/change the anti-hypertensive medications;
  3. Aged between 18-80 year, gender is not limited;
  4. Voluntary to sign on the informed consent.

Exclusion Criteria:

  1. patients with severe cardiac, hepatic or renal dysfunction;
  2. suspicious or confirmed other types of secondary hypertension, including Cushing's syndrome, pheochromocytoma and renal artery stenosis.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03155139


Locations
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China, Chongqing
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing, China, 400016
Sponsors and Collaborators
Qifu Li
Fu Wai Hospital, Beijing, China
Investigators
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Principal Investigator: Jun Cai, phD Hypertension Center, Fuwai Hospital, State Key Laboratory of Cardiovascular Disease of China

Publications of Results:
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Responsible Party: Qifu Li, Primary Investigator, Chongqing Medical University
ClinicalTrials.gov Identifier: NCT03155139     History of Changes
Other Study ID Numbers: PA-China 2017
First Posted: May 16, 2017    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Qifu Li, Chongqing Medical University:
prevalence
primary aldosteronism
hypertension
nationwide
Additional relevant MeSH terms:
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Hypertension
Hyperaldosteronism
Vascular Diseases
Cardiovascular Diseases
Adrenocortical Hyperfunction
Adrenal Gland Diseases
Endocrine System Diseases