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Resistant HypertensionNCT06228677

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

An observational study of Resistant Hypertension and Secondary Hypertension, run by First Affiliated Hospital of Chengdu Medical College at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

To explore the relationship between perioperative blood pressure and catecholamine concentrations in adrenal venous blood and peripheral venous blood in hypertensive patients with primary aldosteronism (PA) who underwent percutaneous selective adrenal artery embolization (SAAE). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Selective adrenal artery embolization
Type of treatment
Surgery or procedure
How many people
196 participants
Where
1 siteChina
Study dates
18 Sep 2023to 31 Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Hypertensive patients with a definite diagnosis of primary aldosteronism who agree to undergo percutaneous selective adrenal artery embolization.

Who may be able to join

  • Age ≥18 years with no gender restrictions.
  • Adherence to the "Primary Aldosteronism" Diagnosis and Treatment Guidelines, confirmed diagnosis of primary aldosteronism following rigorous drug washout, and identification as either aldosteronoma or idiopathic aldosteronism via adrenal vein blood sampling.
  • Blood pressure metrics that satisfy any of the subsequent conditions: a) Clinic-recorded blood pressure ≥140/90mmHg; b) 24-hour ambulatory blood pressure monitoring results displaying average blood pressure >130/80 mmHg or daytime readings >135/85 mmHg.
  • Adrenal CT scan revealing adrenal hyperplasia, nodular formations, or no significant morphological deviations.
  • Hypertension history surpassing a duration of 6 months.
  • Prior to screening, patients or their lawful guardians must provide a signed informed consent, sanctioned by the ethics committee.

Who cannot join

  • Patients diagnosed with primary hypertension or secondary hypertension attributed to other etiologies.
  • Female participants who are presently pregnant, lactating, or with intentions to conceive within the forthcoming year.
  • Presence of significant systemic diseases, with particular attention to hepatic and renal dysfunction.
  • Pronounced allergic reaction to contrast agents.
  • Any other serious systemic diseases with a life expectancy of less than 12 months.
  • Participants concurrently enrolled or expressing interest to participate in other clinical trials, the outcomes of which could potentially influence the results of the current study.
  • The researcher's discretion deems the subject inappropriate for inclusion in the study for any given reason.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site, 1 recruiting
  • The First Affiliated Hospital of Chengdu Medical College

    Chengdu, Sichuan, 610500

    Peijian Wang, PhD, 028-83016145 ext. +86, wpjmed@aliyun.com

    Recruiting

Other trials in China

About this study

Official title: Comparison of Catecholamine Concentrations in Adrenal Venous Blood and Peripheral Venous Blood During Percutaneous Selective Adrenal Artery Embolization in Hypertensive Patients With Primary Aldosteronism: A Prospective Cohort Study

To explore the relationship between perioperative blood pressure and catecholamine concentrations in adrenal venous blood and peripheral venous blood in hypertensive patients with primary aldosteronism (PA) who underwent percutaneous selective adrenal artery embolization (SAAE). In order to elucidate the related phenomena and possible mechanisms of blood pressure fluctuations caused by SAAE treatment in hypertensive patients with PA.

Read the detailed description

Percutaneous selective adrenal artery embolization (SAAE) is a minimally invasive interventional procedure that allows for necrosis of diseased adrenal glands by selectively embolizing the adrenal arteries supplying the lesion using an embolic agent to block the overproduction of aldosterone, and has been used as a treatment for PA as a minimally invasive alternative. However, it is of concern that in our team's SAAE practice, we have found that some patients with PA experience a dramatic increase in blood pressure during surgery, even exceeding 220/130 mmHg, yet some patients do not experience significant fluctuations in blood pressure. The perioperative risk is undoubtedly significantly increased for patients with high blood pressure fluctuations. What are the reasons for this discrepancy phenomenon? Therefore, the present study was designed to synchronize adrenal vein blood collection in PA hypertensive patients undergoing SAAE, and to compare the perioperative adrenal vein blood and peripheral venous blood catecholamine concentrations, with a view to discovering the patterns and possible causes of blood pressure fluctuations, hormone level changes, and other phenotypic changes, and elucidating the possible mechanisms of blood pressure fluctuations triggered by SAAE treatment of PA hypertension, in order to provide an evidence-based basis for minimally invasive interventional therapy for PA.

Being tested
Selective adrenal artery embolization
Keywords
Primary Aldosteronism, Selective Adrenal Artery Embolization, catecholamine concentration, Adrenal Venous Blood, Blood Pressure Variability
Medical subject headings
Hyperaldosteronism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Selective adrenal artery embolizationProcedure or surgery

    Percutaneous selective adrenal artery embolization in patients with primary aldosteronism

Study groups in NCT06228677
Study groupRoleWhat they receive
Adrenal Venous Sampling GroupAdrenal veinous sampling in patients with primary aldosteronism who underwent percutaneous selective adrenal artery embolization
Receives: Procedure: Selective adrenal artery embolization
Peripheral Venous Sampling GroupPeripheral veinous sampling in patients with primary aldosteronism who underwent percutaneous selective adrenal artery embolization
Receives: Procedure: Selective adrenal artery embolization

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Invasive blood pressure

    Auxiliary check

    Measured: Selective adrenal artery embolization immediately, after 5 minutes, 15 minutes, 30 minutes

  2. 24-hour dynamic blood pressure

    Auxiliary check

    Measured: Selective adrenal artery embolization before 24 hours, after 24 hours

  3. Plasma Norepinephrine

    Biochemical indicators

    Measured: Selective adrenal artery embolization immediately, after 5 minutes, 15 minutes, 30 minutes

  4. Plasma Adrenaline

    Biochemical indicators

    Measured: Selective adrenal artery embolization immediately, after 5 minutes, 15 minutes, 30 minutes

  5. Plasma Dopamin

    Biochemical indicators

    Measured: Selective adrenal artery embolization immediately, after 5 minutes, 15 minutes, 30 minutes

  6. Plasma Renin

    Biochemical indicators

    Measured: Selective adrenal artery embolization immediately, after 5 minutes, 15 minutes, 30 minutes

  7. Plasma Aldosterone

    Biochemical indicators

    Measured: Selective adrenal artery embolization immediately, after 5 minutes, 15 minutes, 30 minutes

  8. Serum sodium

    Biochemical indicators

    Measured: Selective adrenal artery embolization immediately, after 5 minutes, 15 minutes, 30 minutes

  9. Serum potassium

    Biochemical indicators

    Measured: Selective adrenal artery embolization immediately, after 5 minutes, 15 minutes, 30 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jan 2024
  2. Study start18 Sep 2023
  3. Primary completion30 Jun 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
196 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06228677
Sponsor's protocol ID
CCC-SAAE
Status last verified
Jan 2024
First submitted
19 Jan 2024
Last updated
29 Jan 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Shared with the researchers' consent

Publications

  • Stavropoulos K, Imprialos KP, Patoulias D, Katsimardou A, Doumas M. Impact of Primary Aldosteronism in Resistant Hypertension. Curr Hypertens Rep. 2022 Aug;24(8):285-294. doi: 10.1007/s11906-022-01190-9. Epub 2022 Apr 21.

    PubMed 35445928
  • Huang WC, Lin YH, Wu VC, Chen CH, Siddique S, Chia YC, Tay JC, Sogunuru G, Cheng HM, Kario K. Who should be screened for primary aldosteronism? A comprehensive review of current evidence. J Clin Hypertens (Greenwich). 2022 Sep;24(9):1194-1203. doi: 10.1111/jch.14558.

    PubMed 36196469
  • Meng Z, Dai Z, Huang K, Xu C, Zhang YG, Zheng H, Liu TZ. Long-Term Mortality for Patients of Primary Aldosteronism Compared With Essential Hypertension: A Systematic Review and Meta-Analysis. Front Endocrinol (Lausanne). 2020 Mar 10;11:121. doi: 10.3389/fendo.2020.00121. eCollection 2020.

    PubMed 32210920
  • Monticone S, D'Ascenzo F, Moretti C, Williams TA, Veglio F, Gaita F, Mulatero P. Cardiovascular events and target organ damage in primary aldosteronism compared with essential hypertension: a systematic review and meta-analysis. Lancet Diabetes Endocrinol. 2018 Jan;6(1):41-50. doi: 10.1016/S2213-8587(17)30319-4. Epub 2017 Nov 9.

    PubMed 29129575
  • Funder JW, Carey RM. Primary Aldosteronism: Where Are We Now? Where to From Here? Hypertension. 2022 Apr;79(4):726-735. doi: 10.1161/HYPERTENSIONAHA.121.18761. Epub 2022 Jan 24.

    PubMed 35067069
  • Funder JW, Carey RM, Mantero F, Murad MH, Reincke M, Shibata H, Stowasser M, Young WF Jr. The Management of Primary Aldosteronism: Case Detection, Diagnosis, and Treatment: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2016 May;101(5):1889-916. doi: 10.1210/jc.2015-4061. Epub 2016 Mar 2.

    PubMed 26934393
  • Lu YC, Liu KL, Wu VC, Wang SM, Lin YH, Chueh SJ, Wu KD, Su YR, Huang KH; TAIPAI Study Group. Unilateral adrenalectomy in bilateral adrenal hyperplasia with primary aldosteronism. J Formos Med Assoc. 2023 May;122(5):393-399. doi: 10.1016/j.jfma.2022.12.015. Epub 2023 Feb 20.

    PubMed 36813699
  • Tezuka Y, Turcu AF. Real-World Effectiveness of Mineralocorticoid Receptor Antagonists in Primary Aldosteronism. Front Endocrinol (Lausanne). 2021 Mar 26;12:625457. doi: 10.3389/fendo.2021.625457. eCollection 2021.

    PubMed 33841329
  • Fowler AM, Burda JF, Kim SK. Adrenal artery embolization: anatomy, indications, and technical considerations. AJR Am J Roentgenol. 2013 Jul;201(1):190-201. doi: 10.2214/AJR.12.9507.

    PubMed 23789675
  • Hokotate H, Inoue H, Baba Y, Tsuchimochi S, Nakajo M. Aldosteronomas: experience with superselective adrenal arterial embolization in 33 cases. Radiology. 2003 May;227(2):401-6. doi: 10.1148/radiol.2272011798. Epub 2003 Apr 3.

    PubMed 12676966
  • Zhao Z, Liu X, Zhang H, Li Q, He H, Yan Z, Sun F, Li Y, Zhou X, Bu X, Wu H, Shen R, Zheng H, Yang G, Zhu Z; Chongqing Endocrine Hypertension Collaborative Team. Catheter-Based Adrenal Ablation Remits Primary Aldosteronism: A Randomized Medication-Controlled Trial. Circulation. 2021 Aug 17;144(7):580-582. doi: 10.1161/CIRCULATIONAHA.121.054318. Epub 2021 Aug 16. No abstract available.

    PubMed 34398686
  • Zhou Y, Liu Q, Wang X, Wan J, Liu S, Luo T, He P, Hou J, Pu J, Wang D, Liang D, Yang Y, Wang P. Adrenal Ablation Versus Mineralocorticoid Receptor Antagonism for the Treatment of Primary Aldosteronism: A Single-Center Prospective Cohort Study. Am J Hypertens. 2022 Dec 8;35(12):1014-1023. doi: 10.1093/ajh/hpac105.

    PubMed 36205513

Questions about this trial

What is this clinical trial studying?

An observational study of Resistant Hypertension and Secondary Hypertension, run by First Affiliated Hospital of Chengdu Medical College at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Peijian Wang, PhD (028-83016145 ext. +86, wpjmed@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Invasive blood pressure (time frame: Selective adrenal artery embolization immediately, after 5 minutes, 15 minutes, 30 minutes). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06228677, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2024.

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