Superselective Adrenal Arterial Embolization for Resistant Hypertension

NCT05552300 | Unknown DMC

• 1 other identifier: SAAE-RHT
• Study Type: interventional
• Target: 144
• Locations: 0 countries
• Sites: N/A

Brief Summary

Resistant hypertension (RH) is usually defined as blood pressure (BP) that remains above guideline-specified targets despite the use of three or more antihypertensive agents at optimal or maximally tolerated doses, with one of those agents preferably being a diuretic. It is not uncommon, being identified in 10 to 30% of hypertensive patients and it is known to be a risk factor for cardiovascular (CV) events, including stroke, myocardial infarction (MI), heart failure (HF), and CV mortality, as well as adverse renal events,including chronic kidney disease (CKD) and end-stage kidney disease (ESKD). The activation of the renin-angiotensin-aldosterone system (RAAS) and sympatho-adrenomedullary system can play a pathogenic role in triggering and sustaining RH. SAAE is a catheter-based percutaneous transluminal procedure which selectively injects ethanol into adrenal artery to ablate part of the adrenal gland for suppression of excessive aldosterone and catecholamines. Therefore, SAAE is a minimally invasive procedure that might be used as an alternative strategy to antihypertensive drugs or reduce the intensity of antihypertensive drugs.

Conditions

Resistant Hypertension

Outcome Measures

Primary Outcomes (1)

• Change of 24-h average systolic blood pressure

  Difference in the change of 24-h average systolic blood pressure between the intervention and control group

  6-month

Secondary Outcomes (17)

• Change of 24-h average diastolic blood pressure, daytime mean systolic blood pressure, daytime mean diastolic blood pressure, and nighttime average systolic and diastolic blood pressure

  6-month

• Change of the number of antihypertensive medications

  6-month

• Change of home systolic and diastolic pressure

  6-month

• Change of office systolic and diastolic pressure

  6-month

• Change of blood electrolytes (K+, Na +)

  6-month

Study Arms (2)

Superselective adrenal arterial embolization

EXPERIMENTAL

Selectively injects ethanol into adrenal artery to ablate part of the adrenal gland Interventions: Procedure: superselective adrenal arterial embolization Drug: traditional triple antihypertensive treatment

Procedure: SAAE; Drug: traditional triple antihypertensive treatment

Traditional triple antihypertensive treatment

ACTIVE COMPARATOR

No intervention, but treated with traditional triple antihypertensive treatment

Drug: traditional triple antihypertensive treatment

Interventions

SAAE PROCEDURE

SAAE is a catheter-based percutaneous transluminal procedure which selectively injects ethanol into adrenal artery to ablate part of the adrenal gland for suppression of excessive aldosterone and catecholamines

Superselective adrenal arterial embolization

traditional triple antihypertensive treatment DRUG

irbesartanhydrochlorothiazide 162.5 mg/d, amlodipine 5 mg/d

Superselective adrenal arterial embolization; Traditional triple antihypertensive treatment

Eligibility Criteria

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

You may qualify if:

• Male or female, aged between 18-65 years old.
• Patients with resist hypertension (office systolic blood pressure ≥140 mmHg, and/or office diastolic blood pressure ≥90 mmHg, and/or 24-h average systolic blood pressure ≥130 mmHg) with rational lifestyle change and triple antihypertensive drugs (irbesartanhydrochlorothiazide 162.5 mg/d, amlodipine 5 mg/d) for at least 4 weeks.
• Informed consent signed and agreed to participate in this trial.

You may not qualify if:

• Secondary hypertension
• Adrenergic insufficiency.
• adrenocortical insufficiency
• Renal failure eGFR\<60 mL/min/1.73 m2
• Heart failure with NYHA grade Ⅱ-Ⅳ grade or unstable angina, severe cardiovascular and cerebrovascular stenosis, myocardial infarction, intracranial aneurysm, stroke and other acute cardiovascular events.
• Acute infections, tumors and severe arrhythmias, psychiatric disorders, drugs or alcohol addicts.
• Liver dysfunction or the following history of liver disease: AST or ALT 3 times higher than the upper limit, liver cirrhosis, history of hepatic encephalopathy, esophageal variceal history or portal shunt history.
• Fertile woman without contraceptives.
• Coagulation dysfunction.
• Pregnant women or lactating women.
• Participated in other clinical trials or admitted with other research drugs within 3 months prior to the trial.
• Any surgical or medical condition which can significantly alter the absorption, distribution, metabolism, or excretion of any study drug.
• Allergy or any contraindications for the study drugs, contrast agents and alcohol.
• History of depression, schizophrenia or vascular dementia.
• Refused to sign informed consent

Sponsors & Collaborators

• First Affiliated Hospital of Chengdu Medical College: lead

Related Publications (5)

• Bourque G, Hiremath S. Rethinking Resistant Hypertension. J Clin Med. 2022 Mar 7;11(5):1455. doi: 10.3390/jcm11051455.

  PMID: 35268545 RESULT

• Dong H, Zou Y, He J, Deng Y, Chen Y, Song L, Xu B, Gao R, Jiang X. Superselective adrenal arterial embolization for idiopathic hyperaldosteronism: 12-month results from a proof-of-principle trial. Catheter Cardiovasc Interv. 2021 May 1;97 Suppl 2:976-981. doi: 10.1002/ccd.29554. Epub 2021 Feb 19.

  PMID: 33605538 RESULT

• Giurazza F, Corvino F, Silvestre M, Cangiano G, Cavaglia E, Amodio F, De Magistris G, Frauenfelder G, Niola R. Adrenal glands hemorrhages: embolization in acute setting. Gland Surg. 2019 Apr;8(2):115-122. doi: 10.21037/gs.2018.10.06.

  PMID: 31183321 RESULT

• Zhou Q, Liu X, Zhang H, Zhao Z, Li Q, He H, Zhu Z, Yan Z. Adrenal Artery Ablation for the Treatment of Hypercortisolism Based on Adrenal Venous Sampling: A Potential Therapeutic Strategy. Diabetes Metab Syndr Obes. 2020 Oct 6;13:3519-3525. doi: 10.2147/DMSO.S262092. eCollection 2020.

  PMID: 33116703 RESULT

• 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.

  PMID: 34398686 RESULT

Study Officials

• Peijian Wang

  Clinical Medical College and The First Affiliated Hospital of Chengdu Medical College

  STUDY CHAIR

Central Study Contacts

Yaqiong Zhou, MD

CONTACT

+8615184399329; 1273868593@qq.com

Yanqiu M Yang

CONTACT

+8617380086816; 285965467@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2022
• First Posted: September 23, 2022
• Study Start: October 1, 2022
• Primary Completion: October 1, 2024
• Study Completion: March 31, 2025
• Last Updated: September 23, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share