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NCT Number: NCT04269928

Effects of Adrenal Artery Ablation and Adrenalectomy in Patients With Primary Aldosteronism

Primary aldosteronism (PA) is the main cause of secondary hypertension, affecting 5-15% of the general hypertensive population. Early diagnosis and treatment are of crucial importance as patients with PA are more susceptible to cardiovascular and cerebrovascular morbidity and mortality than blood-pressure-matched hypertensive patients.

Current guidelines indicate that mineralocorticoid receptor (MR) antagonists and laparoscopic adrenalectomy are the principal treatments for PA.Laparoscopic adrenalectomy is recommended for patients with aldosteronoma or unilateral adrenal hyperplasia. During the past two decades, catheter-based arterial embolization or computed tomography (CT)-guided radiofrequency thermogenesis have been used for aldosteronomas treatment. Although these procedures are claimed to be effective for treatment of aldosteronomas, the evidence comes mostly from case reports or small series. In addition, some PA patients refuse surgery and are intolerant of the adverse effects of MR antagonists; others have persistence of PA after adrenelectomy, but respond poorly to MR antagonists. An alternative therapy is needed in such cases.

In recent years, adrenal artery ablation has also been used to treat primary aldosteronism, which can reduce the level of aldosterone and blood pressure, but its efficacy and safety are not clear. To confirm the effect of adrenal artery ablation on blood pressure, RAAS system and blood potassium, the researchers conducted a parallel control clinical study of patients with primary aldosteronism (Aldosteronoma).

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Key information

Conditions

Primary Aldosteronism Adrenal Gland Diseases Adrenocortical Hyperfunction Cardiovascular Diseases Endocrine System Diseases Hyperaldosteronism Hypertension Vascular Diseases

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The third hospital affiliated to the Army Medical University

Chongqing, Chongqing Municipality, 400042, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Primary aldosteronis diagnosed by increased aldosterone-to-renin ratio (ARR) and serum aldosterone levels ≥15 ng / dl, and confirmed by saline injection test or captopril inhibition test.
  • Aldosteronoma had lateralization by adrenal venous sampling (AVS) and confirmed with CT
  • Signed informed consent and agreed to participate in this study.

Exclusion criteria

  • Aldosterone cancer.
  • Hyperkalemia.
  • Renal failure or the following history of nephropathy: serum creatinine 1.5 times higher than the upper limit; dialysis history; or nephrotic syndrome.
  • Secondary hypertension except the primary aldosteronism.
  • Adrenergic insufficiency.
  • Heart failure with NYHA 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 2 times higher than the upper limit, liver cirrhosis, history of hepatic encephalopathy, esophageal variceal history or portal shunt history.
  • 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.
  • Allergy or any contraindications for contrast agents and alcohol.
  • Refused to sign informed consent

Treatment and study plan

Endovascular chemical ablation of adrenal gland

Procedure

Patients in this group will be treated with ablation of adrenal gland by endovascular injection of dehydrated alcohol

Primary outcomes

  1. Change of office systolic and diastolic pressure

    Time frame: 52 weeks (End of Trial)

    Change of office systolic and diastolic pressure between the intervention and control group at the end of the study (24 weeks)

Secondary outcomes

  1. Change of 24-h average systolic blood pressure

    Time frame: 52 weeks (End of Trial)

    Change of 24-h average systolic blood pressure between the intervention and control group at the end of the study (24 weeks)

  2. Change of 24-h average diastolic blood pressure

    Time frame: 52 weeks (End of Trial)

    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 at the end of the study (24 weeks)

  3. Change of home systolic and diastolic pressure

    Time frame: 52 weeks (End of Trial)

    Change of home systolic and diastolic pressure between the intervention and control group at the end of the study (24 weeks)

  4. Change of anti-hypertensive regimen

    Time frame: 52 weeks (End of Trial)

    Change of number, classes, and combinations of classes of antihypertensive drugs between the intervention and control group at the end of the study (24 weeks)

  5. Change of blood electrolytes（serum potassium and natrium in mmol/L）

    Time frame: 52 weeks (End of Trial)

    Change of blood electrolytes（serum potassium and natrium in mmol/L）compared with baseline, and between the intervention and control group at the end of the study (24 weeks)between the intervention and control group at the end of the study (24 weeks)

  6. Change of aldosterone-to-renin ratio (ARR）

    Time frame: 52 weeks (End of Trial)

    Change of aldosterone-to-renin ratio (ARR）compared with baseline, and between the intervention and control group at the end of the study (24 weeks)

  7. Change of plasma aldosterone

    Time frame: 52 weeks (End of Trial)

    Change of plasma aldosterone compared with baseline, and between the intervention and control group at the end of the study (24 weeks)

  8. Change of plasma renin

    Time frame: 52 weeks (End of Trial)

    Change of plasma renin compared with baseline, and between the intervention and control group at the end of the study (24 weeks)

  9. Change of plasma cortisol

    Time frame: 52 weeks (End of Trial)

    Change of plasma cortisol compared with baseline, and between the intervention and control group at the end of the study (24 weeks)

  10. Change of serum creatinine

    Time frame: 52 weeks (End of Trial)

    Change of serum creatinine compared with baseline, and between the intervention and control group at the end of the study (24 weeks)

  11. Change of estimated glomerular filtration rate(eGFR)

    Time frame: 52 weeks (End of Trial)

    Change of estimated glomerular filtration rate(eGFR) compared with baseline, and between the intervention and control group at the end of the study (24 weeks)

  12. Change of 24-h urine microalbumin, microalbumin/creatinine ratio

    Time frame: 52 weeks (End of Trial)

    Change of 24-h urine microalbumin, microalbumin/creatinine ratio compared with baseline, and between the intervention and control group at the end of the study (24 weeks)

Sponsors and collaborators

Lead sponsor

Third Military Medical University

Other

Registry information

Official study title

An Parallel Control Clinical Trail on Effects of Adrenal Artery Ablation and Adrenalectomy in Patients With Primary Aldosteronism

Important dates

Study start
2016
Primary completion
2019
Study completion
2021
First posted
Feb 17, 2020
Registry last updated
Mar 22, 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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