Chongqing Primary Aldosteronism Study

Sponsor
Chongqing Medical University (Other)
Overall Status
Recruiting
CT.gov ID
NCT03224312
Collaborator
(none)
1,500
1
147
10.2

Study Details

Study Description

Brief Summary

We intends to conduct a series of original clinical research about PA, and establish a large cohort of PA and essential hypertension patients with long-term follow-up of cardiovascular events, renal end points etc. We will establish a large sample of blood, urine, adrenal tissue of the subjects, and the genomics,metabonomics, proteomics database, to explore the mechanism of the PA and target organ damage, risk factors, diagnostic methods and biomarkers.

Condition or Disease Intervention/Treatment Phase
  • Other: no intervention

Detailed Description

This study will include the subjects of a series of studies on hypertension conducted by our team, including essential hypertension, PA subjects, and establish a large sample database and specimen bank through follow-up and omics analysis.

Study Design

Study Type:
Observational
Anticipated Enrollment :
1500 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Chongqing Primary Aldosteronism Study
Actual Study Start Date :
Oct 1, 2016
Anticipated Primary Completion Date :
Dec 31, 2027
Anticipated Study Completion Date :
Dec 31, 2028

Arms and Interventions

Arm Intervention/Treatment
Primary aldosteronism

screened, confirmed and subtyped according to the guidelines.

Other: no intervention
no intervention

Essential hypertension

screened for PA and excluded the diagnosis of PA as well as other secondary hypertesion

Other: no intervention
no intervention

Outcome Measures

Primary Outcome Measures

  1. numbers of patients who develop cardiovascular events [1-15 years]

    compare the long-term cardiovascular and cerebrovascular events in patients with primary aldosteronism and essential hypertension

Secondary Outcome Measures

  1. estimated glomerular filtration rate (eGFR) [1-15 years]

    Compare the incidence of hypertensive nephropathy between two groups (based on eGFR)

  2. The incidence of new atrial fibrillation [1-15 years]

    Compare the occurrence of new atrial fibrillation between patients with primary aldosteronism and essential hypertension

  3. The incidence of left ventricular hypertrophy [1-15 years]

    Compare the occurrence of left ventricular hypertrophy between patients with primary aldosteronism and essential hypertension

  4. the variation of carotid intima-media thickness [1-15 years]

    Compare the occurrence of the variation of carotid intima-media thickness between patients with primary aldosteronism and essential hypertension

  5. subgroup analysis of cardiovascular events [1-15 years]

    Compare the cardiovascular and cerebrovascular risk between unilateral PA and idiopathic bilateral adrenal hyperplasia

  6. quality of life score [1-15 years]

    Compare the quality of life between unilateral PA and idiopathic bilateral adrenal hyperplasia by the questionnaire.

  7. Cardiovascular risk score [1-15 years]

    To investigate what kind of cardiovascular risk score can better predict cardiovascular risk of PA

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. hypertensive patients who completed ARR screening and necessary further tests;

  2. Voluntary to sign 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 et al.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Qifu Li Chongqing Chongqing China 400016

Sponsors and Collaborators

  • Chongqing Medical University

Investigators

  • Study Chair: Qifu Li, phD, First Affiliated Hospital of Chongqing Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Qifu Li, Director of endocrinology, First Affiliated Hospital of Chongqing Medical University
ClinicalTrials.gov Identifier:
NCT03224312
Other Study ID Numbers:
  • CONPASS
First Posted:
Jul 21, 2017
Last Update Posted:
Aug 26, 2021
Last Verified:
Aug 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Qifu Li, Director of endocrinology, First Affiliated Hospital of Chongqing Medical University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 26, 2021