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Adrenal Artery Ablation for Primary Aldosteronism With Resistant Hypertension

T

Third Military Medical University

Status

Completed

Conditions

Resistant Hypertension

Treatments

Procedure: Adrenal Artery Ablation

Study type

Interventional

Funder types

Other

Identifiers

NCT04345198
AAA-RHT

Details and patient eligibility

About

Primary aldosteronism(PA) is the most common endocrine cause of resistant hypertension. Surgery and medicine are the main treatment for PA by the current guidelines. However,only a small part of patients with PA meet the surgical criteria, and most of them have to take spironolactone or other antihypertensive drugs for long time. On the other side, long-term inhibition of aldosterone receptor may cause hyperkalemia, male breast hyperplasia and other adverse reactions. Moreover, hyperaldosterone is still not corrected by spironolactone, which cause extensive cerebrovascular damages even though blood pressure and blood potassium had been normalized.

With the development of adrenal vein sampling and adrenal ablation, the precise diagnosis and treatment of PA is possible. Selective adrenal artery ablation (AAA) was observed with significant decrease of blood aldosterone and blood pressure in patients with PA, which made it promissing that primary aldosteronism with resistant hypertension could be relieved by adrenal artery ablation.

Enrollment

36 patients

Sex

All

Ages

30 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Male or female, age between 30-65 years old.
  • Primary aldosteronism with resistant hypertension.
  • Informed consent signed and agreed to participate in this trial.

Exclusion criteria

  • Secodary hyertension due to other causes.
  • History of depression,schizophrenia or vascular dementia .
  • History of cardio-cerebral vascular events such as congestive heart failure, myocardial infarction or stroke within 3 months.
  • Hypohepatia (AST or AST is twice higher than the upper limit) or history of hepatitis or cirrhosis, hepatic encephalopathy.
  • Renal insufficiency ( serum creatinine is 1.5 times higher than the upper limit) or history of dialysis and nephritic syndrome.
  • Acute infections, tumor, severe arrhythmia, mental disorders, alcohol or medicine addiction.
  • Fertile woman without contraceptives.
  • Any surgical or medical conditions that significantly influence absorption, distribution, metabolism or excretion of the anti-hypertensive drugs.
  • Allergic to or have contraindication to the contrast agents and alcohol.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

36 participants in 1 patient group

Intervension
Experimental group
Description:
Adrenal artery ablation is performed in PA patients with resistant hypertension.
Treatment:
Procedure: Adrenal Artery Ablation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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