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Adrenal Artery Ablation Treats Primary Aldosteronism

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ClinicalTrials.gov Identifier: NCT03398785
Recruitment Status : Recruiting
First Posted : January 12, 2018
Last Update Posted : June 27, 2018
Sponsor:
Information provided by (Responsible Party):
Zhiming Zhu, Third Military Medical University

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Primary Aldosteronism Hypertension Procedure: Endovascular chemical Ablation of Adrenal Gland Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Prospective, Controlled Clinical Trial on Effects and Safety of Adrenal Artery Ablation (Triple A) for Primary Aldosteronism
Actual Study Start Date : October 1, 2017
Estimated Primary Completion Date : October 31, 2018
Estimated Study Completion Date : April 30, 2019


Arm Intervention/treatment
Experimental: Intevention
Adrenal Artery Ablation
Procedure: Endovascular chemical Ablation of Adrenal Gland
Patients in this group will be treated with partial ablation of adrenal gland by endovascular injection of dehydrated alcohol.

No Intervention: Control
No intervention, but treated with standard anti-hypertensive drigs



Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03398785


Locations
China, Chongqing
The third hospital affiliated to the Third Military Medical University Recruiting
Chongqing, Chongqing, China, 400042
Contact: Hongbo He, MD.    86-23-68757880    cqhehongbo@gmail.com   
Principal Investigator: Zhiming Zhu, MD.         
Sponsors and Collaborators
Third Military Medical University

Responsible Party: Zhiming Zhu, Director of the department of Hypertension & Endocrinology, Daping Hospital, Third Military Medical University
ClinicalTrials.gov Identifier: NCT03398785     History of Changes
Other Study ID Numbers: Triple A-PA
First Posted: January 12, 2018    Key Record Dates
Last Update Posted: June 27, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Zhiming Zhu, Third Military Medical University:
Primary Aldosteronism
Hypertension
Ablation
Adrenal Gland

Additional relevant MeSH terms:
Hypertension
Hyperaldosteronism
Vascular Diseases
Cardiovascular Diseases
Adrenocortical Hyperfunction
Adrenal Gland Diseases
Endocrine System Diseases
Epinephrine
Racepinephrine
Epinephryl borate
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents