Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Chongqing Primary Aldosteronism Study

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: NCT03224312
Recruitment Status : Active, not recruiting
First Posted : July 21, 2017
Last Update Posted : January 31, 2019
Sponsor:
Information provided by (Responsible Party):
Qifu Li, First Affiliated Hospital of Chongqing Medical University

Brief Summary:
We aimed to assess the target organs damage of hypertention and the occurrence of cardiovascular and cerebrovascular events by a long-term regular follow-up, and discuss the influences of the risk factors.

Condition or disease Intervention/treatment
Primary Aldosteronism Other: no intervention

Detailed Description:
Primary aldosteronism (PA) is caused by adrenocortical lesions characterized with autonomous secretion of aldosterone. It is a common cause of secondary hypertension and its reported prevalence ranges from 5% to 20% in hypertensive patients. Several studies have provided evidence that patients with PA are especially prone to cardiovascular and renal complications, stroke and fibrosis of arteries in PA in comparison with essential hypertension. Unilateral PA is generally treated by adrenalectomy and idiopathic bilateral adrenal hyperplasia is treated with the mineralocorticoid antagonist. However, aldosterone excess may be typically long-standing, and the proinflammatory effects of aldosterone may have led to irreversible damage to the vascular wall, the myocardium, and the kidney, increasing long-term mortality despite initiation of specific treatment. A study demonstrated that either treatment reduced excess renal and cardiovascular morbidity to a level similar to that of matched essential hypertensives. However, no prospective study has so far investigated the risk of cardiovascular and cerebrovascular events and long-term mortality in Chinese PA patients. In this study, we aimed to assess the target organs damage of hypertention and the occurrence of cardiovascular and cerebrovascular events by a long-term regular follow-up, and discuss the influences of the risk factors.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Chongqing Primary Aldosteronism Study
Actual Study Start Date : October 1, 2016
Estimated Primary Completion Date : December 31, 2027
Estimated Study Completion Date : December 31, 2028

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Primary aldosteronism Other: no intervention
no intervention

Essential hypertension Other: no intervention
no intervention




Primary Outcome Measures :
  1. numbers of patients who develop cardiovascular events [ Time Frame: 5 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) [ Time Frame: 5 years ]
    Compare the incidence of hypertensive nephropathy between two groups (based on eGFR)

  2. The incidence of new atrial fibrillation [ Time Frame: 5 years ]
    Compare the occurrence of new atrial fibrillation between patients with primary aldosteronism and essential hypertension

  3. The incidence of left ventricular hypertrophy [ Time Frame: 5 years ]
    Compare the occurrence of left ventricular hypertrophy between patients with primary aldosteronism and essential hypertension

  4. the variation of carotid intima-media thickness [ Time Frame: 5 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 [ Time Frame: 5 years ]
    Compare the cardiovascular and cerebrovascular risk between unilateral PA and idiopathic bilateral adrenal hyperplasia

  6. quality of life score [ Time Frame: 5 years ]
    Compare the quality of life between unilateral PA and idiopathic bilateral adrenal hyperplasia by the questionnaire.

  7. Cardiovascular risk score [ Time Frame: 5 years ]
    To investigate what kind of cardiovascular risk score can better predict cardiovascular risk of PA


Biospecimen Retention:   Samples With DNA

Serum, plasma and complete blood cell.

Application:

  1. diagnosis of PA and primary hypertension;
  2. differential diagnosis of PA;
  3. finding risk factors of CVD in PA


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
In this study, we aimed to assess the target organs damage of hypertention and the occurrence of cardiovascular and cerebrovascular events by a long-term regular follow-up, and discuss the influences of the risk factors.
Criteria

Inclusion Criteria:

  1. Diagnosis of hypertension, or previously diagnosed Primary Aldosteronism;
  2. Aged between 18-80 year, gender is not limited;
  3. 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 et al.

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): NCT03224312


Locations
Layout table for location information
China, Chongqing
Qifu Li
Chongqing, Chongqing, China, 400016
Sponsors and Collaborators
Chongqing Medical University
Investigators
Layout table for investigator information
Study Chair: Qifu Li, phD First Affiliated Hospital of Chongqing Medical University
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
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: July 21, 2017    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Qifu Li, First Affiliated Hospital of Chongqing Medical University:
Primary aldosteronism
cardiovascular events
cerebrovascular events
Additional relevant MeSH terms:
Layout table for MeSH terms
Hyperaldosteronism
Adrenocortical Hyperfunction
Adrenal Gland Diseases
Endocrine System Diseases