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NCT Number: NCT03398785

Adrenal Artery Ablation Treats Primary Aldosteronism

Primary aldosteronism (PA) is one of the most common cause of endocrine and resistant hypertension. Current studies have shown that the activation of the renin-angiotensin-aldosterone system (RAAS) and the increased sympathetic nerve activity in the central or local tissue are the key mechanisms of high blood pressure and its organ damages.

The classical method for diagnosis of primary aldosteronism depends on the detection of peripheral venous blood aldosterone level, which is incapable of accurate positioning diagnosis. On the other hand, the current guidelines recommend that surgery and aldosterone receptor inhibitors were the only treatment for primary aldosteronism. However, only about 35% of aldosterone tumors and a small part of unilateral adrenal hyperplasia can be treated by surgery. More than 60% of idiopathic aldosteronism and bilateral adrenal hyperplasia need long-term drug therapy. However, long-term aldosterone inhibitor treatment may also cause hyperkalemia, male breast hyperplasia, female hirsutism and other adverse reactions.

Therefore, the investigators proposed that endovascular chemical partial ablation of the adrenal gland can lower the aldosterone level, reduce the blood pressure and recover the potassium metabolism balance. In order to confirm the above effects, the investigators conduct an open, prospective, positive controlled study in patients with primary aldosteronism patients (including aldosterone, idiopathic aldosteronism and adrenal hyperplasia). The effects on blood pressure, blood electrolytes, adrenal hormones, metabolic indexes, target organ damages were observed to explore the efficacy and safety of the endovascular ablation of the adrenal gland in the treatment of primary aldosteronism.

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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–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The third hospital affiliated to the Third Military 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 Renin ratio (ARR) and serum aldosterone levels ≥15 ng / dl, and confirmed by saline injection test or captopril inhibition test.
  • Idiopathic aldosteronism, bilateral adrenal hyperplasia, and unilateral adrenal hyperplasia with no superior secretion confirmed with adrenal CT and adrenal venous blood (AVS).
  • The patients was diagnosed with aldosteronoma or unilateral adrenal hyperplasia but refused to surgical excision.
  • 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 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 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.
  • 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.
  • Refused to sign informed consent

Treatment and study plan

Endovascular chemical ablation of adrenal gland

Procedure

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

Primary outcomes

  1. Change of 24-h average systolic blood pressure compared with the baseline

    Time frame: 24 weeks

    Change of 24-h average systolic blood pressure compared with the baseline at the end of the study (24 weeks) in the intervention group.

Secondary outcomes

  1. Change of 24-h average systolic blood pressure between two groups

    Time frame: 24 weeks

    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 anti-hypertensive regimen between two groups

    Time frame: 24 weeks

    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)

  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 between two groups

    Time frame: 24 weeks

    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)

  4. Change of office systolic and diastolic pressure between two groups

    Time frame: 24 weeks

    Change of office systolic and diastolic pressure 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: 24 weeks

    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)

  6. Change of plasma aldosterone and 24-h urine aldosterone

    Time frame: 24 weeks

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

  7. Change of plasma renin

    Time frame: 24 weeks

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

  8. Change of plasma cortisol and 24-h urine cortisol

    Time frame: 24 weeks

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

  9. Change of liver enzymes (ALT, AST)

    Time frame: 24 weeks

    Change of liver enzymes (ALT, AST) 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: 24 weeks

    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 fasting blood glucose

    Time frame: 24 weeks

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

  12. Change of lipids profiles (TC, HDL-C, LDL-C, TG) in mmol/L

    Time frame: 24 weeks

    Change of lipids profiles (Total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, triglyceride) in mmol/L compared with baseline, and between the intervention and control group at the end of the study (24 weeks)

Other outcomes

  1. Change of testosterone and estrogen levels

    Time frame: 24 weeks

    Change of testosterone and estrogen levels compared with baseline, and between the intervention and control group at the end of the study (24 weeks)

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

    Time frame: 24 weeks

    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)

  3. Change of parameters assessed by echocardiography (IVSd、IVSs、LVPWd, LVPWs, LVEDD, LVEF, LVM)

    Time frame: 24 weeks

    Change of parameters assessed by echocardiography (IVSd、IVSs、LVPWd, LVPWs, LVEDD, LVEF, LVM) compared with baseline, and between the intervention and control group at the end of the study (24 weeks)

  4. Change of carotid intima-media thickness assessed by carotid ultrasound

    Time frame: 24 weeks

    Change of carotid intima-media thickness(CIMT) assessed by carotid ultrasound compared with baseline, and between the intervention and control group at the end of the study (24 weeks)

  5. Change of electrocardiogram manifestations

    Time frame: 24 weeks

    Change of electrocardiogram manifestations(heart rhythms, heart rates and arrhythmia ) 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 Open-label, Prospective, Controlled Clinical Trial on Effects and Safety of Adrenal Artery Ablation (Triple A) for Primary Aldosteronism

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Jan 12, 2018
Registry last updated
Jul 8, 2019

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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