NCT05561361 The Effect of SAAE on Vascular Endothelial Function in PA Patients
| NCT ID | NCT05561361 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Second Affiliated Hospital of Nanchang University |
| Condition | Primary Aldosteronism |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2022-10-01 |
| Primary Completion | 2026-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2022-10-01 with a primary completion date of 2026-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The study aims to assess the effect of superselective adrenal arterial embolization on vascular endothelial function in patients with primary aldosteronism based on brachial artery flow-mediated relaxation
Eligibility Criteria
Inclusion Criteria: * (1)Aged 18-75 years, males and females; * (2)Blood pressure ≥ 140/90 mmHg on at least three non-same-day office visits without antihypertensive medication or 24-hour ambulatory blood pressure averaging \>130/80 mmHg throughout the day or averaging \>135/85 mmHg during the day; * (3)Primary aldosteronism was diagnosed in accordance with the 2016 international society of Endocrinology clinical guidelines after strict drug elution; * (4)Contraindications to spironolactone-free administration; * (5)No surgical intention or surgical contraindications, and willing to accept drug treatment or percutaneous superselective adrenal artery embolization; * (6)The anatomy of adrenal arteriography is suitable for selective adrenal artery embolization. Exclusion Criteria: * (1)Secondary hypertension of other causes; * (2)Pregnant women or those who have a fertility plan in the next year; * (3)Glomerular filtration rate EGFR \< 45 ml/min/1.73m\^2; * (4)History of severe contrast allergy; * (5)Hyperkalemia; * (6)Patients with other serious organic diseases or life expectancy \< 12 months can not tolerate the treatment of super selective adrenal artery embolizatio; * (7)The diameter of adrenal space occupying lesions was more than 2 cm; * (8)A history of myocardial infarction, syncope, cerebral hemorrhage or cerebral infarction within 3 months before the informed consent; * (9)The results of this study will be affected during the period when patients are enrolled or will participate in other clinical studies.
Contact & Investigator
Yifei Dong
STUDY DIRECTOR
Second Affiliated Hospital of Nanchang University
Frequently Asked Questions
Who can join the NCT05561361 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Primary Aldosteronism. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05561361 currently recruiting?
Yes, NCT05561361 is actively recruiting participants. Contact the research team at yf_dong66@126.com for enrollment information.
Where is the NCT05561361 trial being conducted?
This trial is being conducted at Nanchang, China.
Who is sponsoring the NCT05561361 clinical trial?
NCT05561361 is sponsored by Second Affiliated Hospital of Nanchang University. The principal investigator is Yifei Dong at Second Affiliated Hospital of Nanchang University. The trial plans to enroll 200 participants.