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NCT Number: NCT03155139

Primary Aldosteronism In Hypertensive Patients in China

To investigate the prevalence of primary aldosteronism (PA) in Chinese patients with newly diagnosed hypertension.

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Key information

Conditions

Hyperaldosteronism; Primary Adrenal Gland Diseases Adrenocortical Hyperfunction Cardiovascular Diseases Endocrine System Diseases Hyperaldosteronism Hypertension Hypertension Secondary Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400016, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Aldosterone/renin ratio (ARR) testing

Diagnostic Test

Plasma aldosterone concentration tests, Direct renin concentration tests

Confirmatory tests

Diagnostic Test

Captopril challenge test, Saline infusion test

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Qifu Li

Other

Collaborators

  • Fu Wai Hospital, Beijing, China

Registry information

Acronym: PA-China

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 16, 2017
Registry last updated
Oct 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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