Resistant Hypertension
Conditions
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.
Detailed description
Not Provided
Interventions
PROCEDURESAAE
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
irbesartanhydrochlorothiazide 162.5 mg/d, amlodipine 5 mg/d
Sponsors
First Affiliated Hospital of Chengdu Medical College
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of 24-h average systolic blood pressure | 6-month | Difference in the change of 24-h average systolic blood pressure between the intervention and control group |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of the number of antihypertensive medications | 6-month | Difference in the change of the number of antihypertensive medications between the intervention and control group |
| Change of home systolic and diastolic pressure | 6-month | Difference in the change of home systolic and diastolic pressure between the intervention and control group |
| Change of office systolic and diastolic pressure | 6-month | Difference in the change of office systolic and diastolic pressure between the intervention and control group |
| Change of blood electrolytes (K+, Na +) | 6-month | Difference in the change of blood electrolytes (K+, Na + in mmol/L) between the intervention and control group |
| Change of plasma aldosterone | 6-month | Difference in the change of plasma aldosterone (pg/mL) between the intervention and control group |
| Change of plasma cortisol | 6-month | Difference in the change of plasma cortisol (nmol/L) between the intervention and control group |
| Change of plasma renin measured | 6-month | Difference in the change of plasma renin (pg/ml) between the intervention and control group |
| Change of liver enzymes | 6-month | Difference in the change of liver enzymes (ALT, AST in IU/L) between the intervention and control group |
| 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 | 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 |
| Change of fasting blood glucose | 6-month | Difference in the change of fasting blood glucose in mmol/L between the intervention and control group |
| Change of lipids profiles | 6-month | Difference in the change of lipids profiles (TC, HDL-C, LDL-C, TG) in mmol/L between the intervention and control group |
| Change of 24-h urine microalbumin | 6-month | Difference in the change of 24-h urine microalbumin (mg/L) between the intervention and control group |
| Change of 24-h 24-h urine creatinine | 6-month | Difference in the change of 24-h urine creatinine (umol/L) between the intervention and control group |
| Change of echocardiography parameters (LVEF) | 6-month | Difference in the change of cardiac parameters assessed by echocardiography LVEF (%) between the intervention and control group |
| Change of echocardiography parameters (IVSd、IVSs、LVPWd, LVPWs, LVEDD) | 6-month | Difference in the change of echocardiography parameters (IVSd、IVSs、LVPWd, LVPWs, LVEDD, in millimetre\[mm\]) between the intervention and control group |
| Change of carotid intima-media thickness | 6-month | Difference in the change of carotid intima-media thickness(CIMT) assessed by carotid ultrasound between the intervention and control group |
| Change of kidney function | 6-month | Difference in the change of serum creatinine in umol/L between the intervention and control group |
Contacts
Primary ContactYaqiong Zhou, MD
Backup ContactYanqiu M Yang
Outcome results
None listed