Resistant Hypertension
Conditions
Brief summary
Hypertension is a common problem, affecting \>1.1 billion people worldwide. Unfortunately, fewer than one in five treated patients with hypertension have their blood pressure (BP) under control. The increasing number of people with uncontrolled BP despite the use of three or more antihypertensive agents at optimal or maximally tolerated doses, with one of those agents preferably being a diuretic has been described as the resistant hypertension (RH). Achieving BP control is essential because patients with hypertension who have uncontrolled BP have significantly higher rates of all-cause, cardiovascular, heart disease and cerebrovascular disease mortality compared to normotensive individuals, whereas mortality risk in patients with well-controlled BP does not differ from that in normotensive individuals. There are a number of potential factors that contribute to the suboptimal control of hypertension, including medication non-adherence and prescribing inertia. This highlights the limitations of purely pharmacological approaches for the effective management of hypertension. In fact, the activation of the renin-angiotensin-aldosterone system (RAAS) and sympatho-adrenomedullary system play a pathogenic role in triggering and sustaining RH. Superselective adrenal arterial embolization (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. Over the last decade, unilateral SAAE has emerged as a potential treatment option for patients with primary aldosteronism. Whether this approach can be extrapolated to patients with RH is unclear. We thus set out to perform a randomized trial to compare the safety and efficacy of bilateral SAAE with antihypertensive medications in treating RH.
Interventions
PROCEDUREBiSAAE
SAAE is a catheter-based percutaneous transluminal procedure which selectively injects ethanol into bilateral adrenal artery to ablate part of the adrenal gland for suppression of excessive aldosterone and catecholamines
traditional triple antihypertensive treatment
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
30 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Male or female, aged between 30-65 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 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 home systolic and diastolic pressure | 6-month | Difference in the change of home systolic and diastolic pressure between the intervention and control group |
| Difference in the change of office systolic and diastolic pressure between the intervention and control group | 6-month | Difference in the change of office systolic and diastolic pressure between the intervention and control group |
| Difference in the change of blood electrolytes (K+, Na + in mmol/L) between the intervention and control group | 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 | Change of plasma cortisol |
| 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 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 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 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 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 | Change of echocardiography parameters (LVEF) |
| 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
Backup ContactPeijian Wang
Outcome results
None listed