Primary Aldosteronism: Prospective Screening Registry in China

NCT04020783 | Recruiting DMC

• 1 other identifier: Chinapaps
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Primary Aldosteronism

Keywords

Primary aldosteronism; Screening

Outcome Measures

Primary Outcomes (4)

• ARR positive rate

  ARR positive rate in the high suspicion of PA.

  1 day

• PA confirmed diagnostic rate

  The rate of PA confirmed diagnosis in highly suspected PA population.

  1 month

• The change of office blood pressure

  Comparison of blood pressure between baseline and 6/12/24 months.

  24 months

• The rate of incidence of cardiovascular events

  The rate of incidence of cardiovascular events in the PA patients,such as cerebral infarction, hypertensive nephropathy, myocardial infarction and so on.

  24 months

Study Arms (1)

Observation group

sequential

Other: NO Intervention

Interventions

NO Intervention OTHER

NO Intervention

Observation group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Shanghai Institite of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, 200025, China

RECRUITING

MeSH Terms

Conditions

Hyperaldosteronism

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases

Study Officials

• Jiguang Wang, MD, PhD

  Shanghai Jiao Tong University School of Medicine, Ruijin Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiguang Wang, MD, PhD

CONTACT

+86-21-64370045; jiguangw@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Shanghai Institute of Hypertension

Study Record Dates

• First Submitted: June 26, 2019
• First Posted: July 16, 2019
• Study Start: July 18, 2018
• Primary Completion: October 1, 2024
• Study Completion: December 1, 2024
• Last Updated: August 13, 2024

Record last verified: 2024-08

Locations

CN (1)