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NCT Number: NCT06282107

Effectiveness and Safety of BiSAAE for Resistant Hypertension.

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.

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Key information

Conditions

Resistant Hypertension

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BiSAAE

Procedure

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

Procedure

traditional triple antihypertensive treatment

Primary outcomes

  1. Change of 24-h average systolic blood pressure

    Time frame: 6-month

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

  2. Change of 24-h average systolic blood pressure

    Time frame: 12-month

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

  3. Change of 24-h average systolic blood pressure

    Time frame: 3-month

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

Secondary outcomes

  1. 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

    Time frame: 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

  2. 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

    Time frame: 3-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

  3. 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

    Time frame: 12-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

  4. Change of home systolic and diastolic pressure

    Time frame: 6-month

    Difference in the change of home systolic and diastolic pressure between the intervention and control group

  5. Change of home systolic and diastolic pressure

    Time frame: 12-month

    Difference in the change of home systolic and diastolic pressure between the intervention and control group

  6. Change of home systolic and diastolic pressure

    Time frame: 3-month

    Difference in the change of home systolic and diastolic pressure between the intervention and control group

  7. Difference in the change of office systolic and diastolic pressure between the intervention and control group

    Time frame: 6-month

    Difference in the change of office systolic and diastolic pressure between the intervention and control group

  8. Difference in the change of office systolic and diastolic pressure between the intervention and control group

    Time frame: 12-month

    Difference in the change of office systolic and diastolic pressure between the intervention and control group

  9. Difference in the change of office systolic and diastolic pressure between the intervention and control group

    Time frame: 3-month

    Difference in the change of office systolic and diastolic pressure between the intervention and control group

  10. Difference in the change of blood electrolytes (K+, Na + in mmol/L) between the intervention and control group

    Time frame: 6-month

    Difference in the change of blood electrolytes (K+, Na + in mmol/L) between the intervention and control group

  11. Difference in the change of blood electrolytes (K+, Na + in mmol/L) between the intervention and control group

    Time frame: 12-month

    Difference in the change of blood electrolytes (K+, Na + in mmol/L) between the intervention and control group

  12. Difference in the change of blood electrolytes (K+, Na + in mmol/L) between the intervention and control group

    Time frame: 3-month

    Difference in the change of blood electrolytes (K+, Na + in mmol/L) between the intervention and control group

  13. Change of plasma aldosterone

    Time frame: 6-month

    Difference in the change of plasma aldosterone (pg/mL) between the intervention and control group

  14. Change of plasma aldosterone

    Time frame: 12-month

    Difference in the change of plasma aldosterone (pg/mL) between the intervention and control group

  15. Change of plasma aldosterone

    Time frame: 3-month

    Difference in the change of plasma aldosterone (pg/mL) between the intervention and control group

  16. Change of plasma cortisol

    Time frame: 6-month

    Change of plasma cortisol

  17. Change of plasma cortisol

    Time frame: 12-month

    Change of plasma cortisol

  18. Change of plasma cortisol

    Time frame: 3-month

    Change of plasma cortisol

  19. Change of plasma renin measured

    Time frame: 6-month

    Difference in the change of plasma renin (pg/ml) between the intervention and control group

  20. Change of plasma renin measured

    Time frame: 12-month

    Difference in the change of plasma renin (pg/ml) between the intervention and control group

  21. Change of plasma renin measured

    Time frame: 3-month

    Difference in the change of plasma renin (pg/ml) between the intervention and control group

  22. Change of liver enzymes

    Time frame: 6-month

    Difference in the change of liver enzymes (ALT, AST in IU/L) between the intervention and control group

  23. Change of liver enzymes

    Time frame: 12-month

    Difference in the change of liver enzymes (ALT, AST in IU/L) between the intervention and control group

  24. Change of liver enzymes

    Time frame: 3-month

    Difference in the change of liver enzymes (ALT, AST in IU/L) between the intervention and control group

  25. Change of kidney function

    Time frame: 6-month

    Difference in the change of serum creatinine in umol/L between the intervention and control group

  26. Change of kidney function

    Time frame: 12-month

    Difference in the change of serum creatinine in umol/L between the intervention and control group

  27. Change of kidney function

    Time frame: 3-month

    Difference in the change of serum creatinine in umol/L between the intervention and control group

  28. Change of fasting blood glucose

    Time frame: 6-month

    Difference in the change of fasting blood glucose in mmol/L between the intervention and control group

  29. Change of fasting blood glucose

    Time frame: 3-month

    Difference in the change of fasting blood glucose in mmol/L between the intervention and control group

  30. Change of fasting blood glucose

    Time frame: 12-month

    Difference in the change of fasting blood glucose in mmol/L between the intervention and control group

  31. Change of lipids profiles

    Time frame: 6-month

    Difference in the change of lipids profiles (TC, HDL-C, LDL-C, TG) in mmol/L between the intervention and control group

  32. Change of lipids profiles

    Time frame: 12-month

    Difference in the change of lipids profiles (TC, HDL-C, LDL-C, TG) in mmol/L between the intervention and control group

  33. Change of lipids profiles

    Time frame: 3-month

    Difference in the change of lipids profiles (TC, HDL-C, LDL-C, TG) in mmol/L between the intervention and control group

  34. Change of echocardiography parameters (IVSd、IVSs、LVPWd, LVPWs, LVEDD)

    Time frame: 6-month

    Difference in the change of echocardiography parameters (IVSd、IVSs、LVPWd, LVPWs, LVEDD, in millimetre[mm]) between the intervention and control group

  35. Change of echocardiography parameters (IVSd、IVSs、LVPWd, LVPWs, LVEDD)

    Time frame: 12-month

    Difference in the change of echocardiography parameters (IVSd、IVSs、LVPWd, LVPWs, LVEDD, in millimetre[mm]) between the intervention and control group

  36. Change of echocardiography parameters (IVSd、IVSs、LVPWd, LVPWs, LVEDD)

    Time frame: 3-month

    Difference in the change of echocardiography parameters (IVSd、IVSs、LVPWd, LVPWs, LVEDD, in millimetre[mm]) between the intervention and control group

  37. Change of 24-h urine microalbumin

    Time frame: 6-month

    Difference in the change of 24-h urine microalbumin (mg/L) between the intervention and control group

  38. Change of 24-h urine microalbumin

    Time frame: 12-month

    Difference in the change of 24-h urine microalbumin (mg/L) between the intervention and control group

  39. Change of 24-h urine microalbumin

    Time frame: 3-month

    Difference in the change of 24-h urine microalbumin (mg/L) between the intervention and control group

  40. Change of 24-h urine creatinine

    Time frame: 6-month

    Difference in the change of 24-h urine creatinine (umol/L) between the intervention and control group

  41. Change of 24-h urine creatinine

    Time frame: 12-month

    Difference in the change of 24-h urine creatinine (umol/L) between the intervention and control group

  42. Change of 24-h urine creatinine

    Time frame: 3-month

    Difference in the change of 24-h urine creatinine (umol/L) between the intervention and control group

  43. Change of echocardiography parameters (LVEF)

    Time frame: 6-month

    Change of echocardiography parameters (LVEF)

  44. Change of echocardiography parameters (LVEF)

    Time frame: 12-month

    Change of echocardiography parameters (LVEF)

  45. Change of echocardiography parameters (LVEF)

    Time frame: 3-month

    Change of echocardiography parameters (LVEF)

  46. Change of carotid intima-media thickness

    Time frame: 6-month

    Difference in the change of carotid intima-media thickness(CIMT) assessed by carotid ultrasound between the intervention and control group

  47. Change of carotid intima-media thickness

    Time frame: 12-month

    Difference in the change of carotid intima-media thickness(CIMT) assessed by carotid ultrasound between the intervention and control group

  48. Change of carotid intima-media thickness

    Time frame: 3-month

    Difference in the change of carotid intima-media thickness(CIMT) assessed by carotid ultrasound between the intervention and control group

Study contacts

Contact information is provided by the study sponsor or research team.

Peijian Wang

CONTACT

[email protected]

+861880718263

Yaqiong Zhou

CONTACT

[email protected]

+8615184399329

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Chengdu Medical College

Other

Registry information

Official study title

Effectiveness and Safety of Bilateral Superselective Adrenal Arterial Embolization (BiSAAE) for Resistant Hypertension

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Feb 28, 2024
Registry last updated
Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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