Superselective Adrenal Arterial Embolization for Resistant Hypertension

Resistant Hypertension Clinical Trial

Official title:

Effectiveness and Safety of Superselective Adrenal Arterial Embolization (SAAE) for Resistant Hypertension: A Randomized, Parallel, Controlled Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05552300
• Other study ID #: SAAE-RHT
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: March 31, 2025

Study information

• Verified date: September 2022
• Source: First Affiliated Hospital of Chengdu Medical College
• Contact: Yaqiong Zhou, MD
• Phone: +8615184399329
• Email: 1273868593[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Not Provided

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 144
• Est. completion date: March 31, 2025
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Secondary hypertension

• Adrenergic insufficiency.

• adrenocortical insufficiency

• Renal failure eGFR<60 mL/min/1.73 m2

• Heart failure with NYHA grade ?-? 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

Related Conditions & MeSH terms

• Hypertension
• Resistant Hypertension

Intervention

Procedure:
• SAAE
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

Drug:
• traditional triple antihypertensive treatment
irbesartanhydrochlorothiazide 162.5 mg/d, amlodipine 5 mg/d

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Chengdu Medical College

References & Publications (5)

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

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. — View Citation

Giurazza F, Corvino F, Silvestre M, Cangiano G, Cavaglià 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. — View Citation

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-Controll — View Citation

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/DM — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Difference in the 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 between the intervention and control group	6-month
Secondary	Change of the number of antihypertensive medications	Difference in the change of the number of antihypertensive medications between the intervention and control group	6-month
Secondary	Change of home systolic and diastolic pressure	Difference in the change of home systolic and diastolic pressure between the intervention and control group	6-month
Secondary	Change of office systolic and diastolic pressure	Difference in the change of office systolic and diastolic pressure between the intervention and control group	6-month
Secondary	Change of blood electrolytes (K+, Na +)	Difference in the change of blood electrolytes (K+, Na + in mmol/L) between the intervention and control group	6-month
Secondary	Change of plasma aldosterone	Difference in the change of plasma aldosterone (pg/mL) between the intervention and control group	6-month
Secondary	Change of plasma cortisol	Difference in the change of plasma cortisol (nmol/L) between the intervention and control group	6-month
Secondary	Change of plasma renin measured	Difference in the change of plasma renin (pg/ml) between the intervention and control group	6-month
Secondary	Change of liver enzymes	Difference in the change of liver enzymes (ALT, AST in IU/L) between the intervention and control group	6-month
Secondary	Change of kidney function	Difference in the change of serum creatinine in umol/L between the intervention and control group	6-month
Secondary	Change of fasting blood glucose	Difference in the change of fasting blood glucose in mmol/L between the intervention and control group	6-month
Secondary	Change of lipids profiles	Difference in the change of lipids profiles (TC, HDL-C, LDL-C, TG) in mmol/L between the intervention and control group	6-month
Secondary	Change of 24-h urine microalbumin	Difference in the change of 24-h urine microalbumin (mg/L) between the intervention and control group	6-month
Secondary	Change of 24-h 24-h urine creatinine	Difference in the change of 24-h urine creatinine (umol/L) between the intervention and control group	6-month
Secondary	Change of echocardiography parameters (LVEF)	Difference in the change of cardiac parameters assessed by echocardiography LVEF (%) between the intervention and control group	6-month
Secondary	Change of echocardiography parameters (IVSd?IVSs?LVPWd, LVPWs, LVEDD)	Difference in the change of echocardiography parameters (IVSd?IVSs?LVPWd, LVPWs, LVEDD, in millimetre[mm]) between the intervention and control group	6-month
Secondary	Change of carotid intima-media thickness	Difference in the change of carotid intima-media thickness(CIMT) assessed by carotid ultrasound between the intervention and control group	6-month