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Superselective Adrenal Arterial Embolization for Bilateral Idiopathic Hyperaldosteronism: A Prospective Cohort Study (SAAE-BIH)

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ClinicalTrials.gov Identifier: NCT05186675
Recruitment Status : Not yet recruiting
First Posted : January 11, 2022
Last Update Posted : January 11, 2022
Sponsor:
Information provided by (Responsible Party):
Second Affiliated Hospital of Nanchang University

Brief Summary:
The most common two subtypes of primary aldosteronism (PA ) are aldosterone producing adenoma (APA) and bilateral idiopathic hyperaldosteronism (IHA). Mineralocorticoid receptor (MR) antagonists is the main treatment for bilateral IHA, because of its side effects, the treatment compliance of those patients is poor. Hence, an alternative therapy is needed in such cases. We hypothesized that superselective adrenal artery embolization (SAAE) could be a suitable alternative approach. To our knowledge, SAAE has so far not been applied to treat bilateral IHA. This study aimed to evaluate the efficacy and safety of SAAE in the treatment of PA patients with bilateral IHA.

Condition or disease Intervention/treatment Phase
Primary Aldosteronism Due to Adrenal Hyperplasia (Bilateral) Procedure: superselective adrenal arterial embolization Not Applicable

Detailed Description:

Primary aldosteronism (PA) is the most common form of secondary hypertension, accounting for more than 5% of the general hypertensive cases and 17-20% of resistant hypertension.The most common PA subtype is bilateral idiopathic hyperaldosteronism (IHA), and medical therapy with mineralocorticoid receptor antagonists (MRAs) is recommended for these patients.The clinical studies showed that PA patients had more cardiovascular events than patients with essential hypertension independent of blood pressure, and PA patients with higher plasma aldosterone levels had a higher cardiovascular risk. However, MRAs are unable to reduce the level of plasma aldosterone. Moreover, the undesirable adverse effects of MRAs also limit their wide application, particularly in men.

Superselective adrenal artery embolization (SAAE) has been used as a minimally invasive alternative for the treatment of adrenal tumors. The clinical efficacy of SAAE has been proved by a number of clinical studies. Since the efficacy and safety of SAAE was justified by the treatment of adrenal tumors and APA, we hypothesized that SAAE might cause a significant reduction of blood pressure in cases of hypertension caused by bilateral IHA. Here, we intend to conduct a prospective cohort study to demonstrate the efficacy and safety of SAAE for bilateral IHA with a one-month follow-up.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Percutaneous Superselective Adrenal Arterial Embolization in the Treatment of Primary Aldosteronism With Bilateral Idiopathic Hyperaldosteronism: A Prospective Cohort Study
Estimated Study Start Date : January 1, 2022
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022


Arm Intervention/treatment
Experimental: Superselective adrenal arterial embolization
For patients with bilateral idiopathic hyperaldosteronism confirmed by adrenal venous sampling, Superselective adrenal arterial embolization(SAAE)shall be given according to the patient's wishes. The blood pressure, plasma aldosterone and potassium levels, and adverse events were assessed after SAAE. The primary endpoint was the change in home blood pressure at one months, compared with baseline.
Procedure: superselective adrenal arterial embolization
Superselective adrenal arterial embolization is an operation to inject embolic agent into adrenal artery through catheter to embolize part of adrenal gland, so as to reduce the secretion of adrenal hormone and reduce blood pressure




Primary Outcome Measures :
  1. Ambulatory blood pressure monitoring [ Time Frame: one month after SAAE ]
    24-hour ambulatory blood pressure monitor

  2. Office blood pressure [ Time Frame: one month after SAAE ]
    sphygmomanometer


Secondary Outcome Measures :
  1. plasma aldosterone [ Time Frame: one month after SAAE ]
    reagent

  2. potassium levels [ Time Frame: one month after SAAE ]
    reagent

  3. adverse events [ Time Frame: one month after SAAE ]
    follow-up



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • (1) Age 18-60 years old, regardless of gender; (2) After strict drug elution, it met the diagnostic criteria of primary aldosteronism, and bilateral idiopathic aldosteronism was confirmed by adrenal venous sampling; (3) Blood pressure conditions meet one of the following: 1) Office blood pressure ≥ 140/90mmHg; 2) Ambulatory blood pressure monitoring:whole day blood pressure > 130/80 mmHg or daytime blood pressure > 135/85 mmHg; (4) Adrenal CT showed adrenal hyperplasia, nodules or no obvious morphological abnormalities; (5) The course of hypertension is more than 6 months; (6) The patient or his legal representative shall sign the written informed consent approved by the ethics committee before screening.

Exclusion Criteria:

  • (1) Primary hypertension or secondary hypertension with other causes; (2) A woman who is pregnant or lactating, or has a birth plan in the next year; (3) There are serious organic diseases, especially liver and kidney dysfunction; (4) Severe allergy to contrast medium; (5) Other serious organic diseases, life expectancy < 12 months; (6) Adrenal CT showed adenoma. (7) Patients are enrolled or want to participate in other clinical studies. During the enrollment study, the results of this study will be affected.

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): NCT05186675


Contacts
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Contact: Xiong Hongliang, Master 13870861368 xhlcmu@163.com

Sponsors and Collaborators
Second Affiliated Hospital of Nanchang University
Investigators
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Study Director: Dong Yifei, Doctor Second Affiliated Hospital of Nanchang University
Publications:

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Responsible Party: Second Affiliated Hospital of Nanchang University
ClinicalTrials.gov Identifier: NCT05186675    
Other Study ID Numbers: 2021NDEFY21
First Posted: January 11, 2022    Key Record Dates
Last Update Posted: January 11, 2022
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: From January 2022 to December 2022, 50 cases of bilateral idiopathic aldosteronism were selected; 2023.1-2023.2 complete the follow-up of all enrolled patients; 2023.3-2023.6 statistical data, writing and publishing academic papers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Second Affiliated Hospital of Nanchang University:
primary aldosteronism
hypertension
superselective adrenal arterial embolization
Additional relevant MeSH terms:
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Adrenal Hyperplasia, Congenital
Adrenogenital Syndrome
Hyperaldosteronism
Hyperplasia
Pathologic Processes
Adrenocortical Hyperfunction
Adrenal Gland Diseases
Endocrine System Diseases
Disorders of Sex Development
Urogenital Abnormalities
Congenital Abnormalities
Genetic Diseases, Inborn
Steroid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Metabolic Diseases
Gonadal Disorders
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