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Completed

NCT Number: NCT04345198

Adrenal Artery Ablation for Primary Aldosteronism With Resistant Hypertension

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.

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Key information

Conditions

Resistant Hypertension Adrenal Gland Diseases Adrenocortical Hyperfunction Endocrine System Diseases Hyperaldosteronism

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The third hospital affiliated to the Third Military Medical University

Chongqing, 400042, China

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Adrenal Artery Ablation

Procedure

Intervention with adrenal artery ablation is performed in PA patients with resistant hypertension.

Primary outcomes

  1. Change of office systolic blood ptressure

    Time frame: 24 weeks

    Change of office systolic blood pressure compared with baseline after 24 weeks.

Secondary outcomes

  1. Change of office dystolic blood pressure

    Time frame: 24 weeks

    Change of office dystolic blood pressure compared with baseline after 24 weeks.

  2. Change of home systolic blood pressure

    Time frame: 24 weeks

    Change of home systolic blood pressure compared with baseline after 24 weeks.

  3. Change of home diastolic blood pressure

    Time frame: 24 weeks

    Change of home diastolic blood pressure compared with baseline after 24 weeks.

  4. Change of 24-h average systolic blood pressure

    Time frame: 24 weeks

    Change of 24-h average systolic blood pressure compared with baseline after 24 weeks.

  5. Change of 24-h average diastolic blood pressure

    Time frame: 24 weeks

    Change of 24-h average diastolic blood pressure compared with baseline after 24 weeks.

  6. Change of DDD of anti-hypertensive regimen

    Time frame: 24 weeks

    Change of Defined Daily Dose (DDD) of anti-hypertensive regimen compared with baseline after 24 weeks.

  7. Change of plasma adrenal hormones

    Time frame: 24 weeks

    Change of plasma aldosterone and cortisol compared with baseline after 24 weeks.

  8. Change of plasma renin levels

    Time frame: 24 weeks

    Change of plasma renin levels compared with baseline after 24 weeks.

  9. Change of blood electrolytes

    Time frame: 24 weeks

    Change of serum potassium, natrium, and chlorine compared with baseline after 24 weeks.

  10. Change of serum creatinine

    Time frame: 24 weeks

    Change of serum creatinine measured as umol/L compared with baseline after 24 weeks.

Sponsors and collaborators

Lead sponsor

Third Military Medical University

Other

Registry information

Official study title

Adrenal Artery Ablation Treats Primary Aldosteronism With Resistant Hypertension (AAA-RHT)

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 14, 2020
Registry last updated
Apr 14, 2020

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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