Actively Recruiting

Age: 18Years +
All Genders
ID06228677

Comparison of Catecholamine Concentrations in Adrenal Venous and Peripheral Venous Blood During Percutaneous Selective Adrenal Artery Embolization in Hypertensive Patients With Primary Aldosteronism

Led by First Affiliated Hospital of Chengdu Medical College · Updated on 2024-01-29

196

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating the relationship between blood pressure changes and catecholamine levels in the adrenal venous and peripheral venous blood of patients with primary aldosteronism (PA) who have high blood pressure and undergo percutaneous selective adrenal artery embolization (SAAE). This study aims to understand why some patients experience large blood pressure spikes during SAAE while others do not, and to explore the possible mechanisms behind these blood pressure fluctuations caused by the treatment. The study involves collecting blood samples from two groups: one from the adrenal vein and another from the peripheral vein in patients with PA undergoing SAAE. This minimally invasive procedure blocks blood flow to the affected adrenal gland to reduce excess aldosterone production. Blood pressure and hormone levels including norepinephrine, adrenaline, dopamine, renin, aldosterone, sodium, and potassium will be measured immediately and at intervals up to 30 minutes after embolization. The study will capture detailed blood pressure readings before and after the procedure using invasive and 24-hour monitoring. Participants will be monitored closely during the procedure with multiple blood and blood pressure measurements taken at specific times. Researchers will analyze changes in blood pressure and hormone levels to better understand the physiological effects of SAAE. The study is observational, following patients who meet strict diagnostic and blood pressure criteria for PA. Participants will provide informed consent and be observed until the study concludes at the end of 2026. The findings aim to improve knowledge about blood pressure control during this minimally invasive treatment for PA.

CONDITIONS

Brief Title

Comparison of Catecholamine Concentrations in Venous Blood During Selective Adrenal Artery Embolization

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older with no gender restrictions
  • Diagnosed with primary aldosteronism following drug washout and adrenal vein blood sampling
  • Blood pressure meeting any of: clinic BP ≥140/90 mmHg, 24-hour average BP >130/80 mmHg, or daytime BP >135/85 mmHg
  • Adrenal CT showing hyperplasia, nodules, or normal morphology
  • Hypertension history longer than 6 months
  • Signed informed consent approved by ethics committee
Not Eligible

You will not qualify if you...

  • Primary hypertension or secondary hypertension from other causes
  • Pregnant, breastfeeding, or planning pregnancy within one year
  • Significant liver or kidney dysfunction or other serious systemic diseases
  • Allergic reaction to contrast agents
  • Life expectancy less than 12 months due to serious systemic disease
  • Concurrent participation in other clinical trials affecting this study
  • Investigator's judgment deeming participant inappropriate for study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Selective Adrenal Artery Embolization

Duration - Procedure day with monitoring up to 30 minutes after embolization

Participants undergo percutaneous selective adrenal artery embolization to treat primary aldosteronism. Blood samples from adrenal and peripheral veins and blood pressure measurements are taken during and immediately after the procedure to study hormone levels and blood pressure changes.

1 procedure visit with multiple blood pressure and blood sampling assessments immediately, and at 5, 15, and 30 minutes post-procedure

Post-procedure Monitoring

Duration - 2 days around the procedure

Participants have 24-hour dynamic blood pressure monitoring before and after the embolization procedure to observe blood pressure changes related to treatment.

2 visits for 24-hour blood pressure monitoring before and after embolization

Trial Site Locations

Total: 1 location

1

The First Affiliated Hospital of Chengdu Medical College

Chengdu, Sichuan, China, 610500

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Research Team

P

Peijian Wang, PhD

S

Sen Liu, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Published Research Related To This Trial

Long-Term Mortality for Patients of Primary Aldosteronism Compared With Essential Hypertension: A Systematic Review and Meta-Analysis.

Zhe Meng, Zhe Dai, Kai Huang...

https://pubmed.ncbi.nlm.nih.gov/32210920

Cardiovascular events and target organ damage in primary aldosteronism compared with essential hypertension: a systematic review and meta-analysis.

Silvia Monticone, Fabrizio D'Ascenzo, Claudio Moretti...

https://pubmed.ncbi.nlm.nih.gov/29129575

The Management of Primary Aldosteronism: Case Detection, Diagnosis, and Treatment: An Endocrine Society Clinical Practice Guideline.

John W Funder, Robert M Carey, Franco Mantero...

https://pubmed.ncbi.nlm.nih.gov/26934393