- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04269928
Effects of Adrenal Artery Ablation and Adrenalectomy in Patients With Primary Aldosteronism
An Parallel Control Clinical Trail on 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).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Chongqing
-
Chongqing, Chongqing, China, 400042
- The third hospital affiliated to the Army Medical University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Adrenal Artery Ablation
Patients in the intervention group will be treated with ablation of adrenal gland by endovascular injection of dehydrated alcohol
|
Patients in this group will be treated with ablation of adrenal gland by endovascular injection of dehydrated alcohol
|
Adrenalectomy
Patients in this group will be treated with unilateral laparoscopic adrenalectomy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
52 weeks (End of Trial)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
52 weeks (End of Trial)
|
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)
|
52 weeks (End of Trial)
|
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)
|
52 weeks (End of Trial)
|
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)
|
52 weeks (End of Trial)
|
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)
|
52 weeks (End of Trial)
|
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)
|
52 weeks (End of Trial)
|
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)
|
52 weeks (End of Trial)
|
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)
|
52 weeks (End of Trial)
|
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)
|
52 weeks (End of Trial)
|
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)
|
52 weeks (End of Trial)
|
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)
|
52 weeks (End of Trial)
|
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)
|
52 weeks (End of Trial)
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Endocrine System Diseases
- Adrenocortical Hyperfunction
- Adrenal Gland Diseases
- Hypertension
- Hyperaldosteronism
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Adrenergic beta-Agonists
- Sympathomimetics
- Vasoconstrictor Agents
- Mydriatics
- Epinephrine
- Racepinephrine
- Epinephryl borate
Other Study ID Numbers
- Quadruple A -PA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hypertension
-
National Taiwan University Hospital Hsin-Chu BranchRecruitingHypertension,Essential | Hypertension, MaskedTaiwan
-
University of Alabama at BirminghamTroy UniversityCompletedHypertension | Hypertension, Resistant to Conventional Therapy | Uncontrolled Hypertension | Hypertension, White CoatUnited States
-
BayerCompletedPrimary HypertensionChina
-
Columbia UniversityAgency for Healthcare Research and Quality (AHRQ)Active, not recruitingWhite Coat Hypertension | Hypertension,EssentialUnited States
-
Addpharma Inc.Completed
-
Universidade Federal de Santa MariaCompletedHealthy Volunteers | Hypertension, EssentialBrazil
-
Sheffield Teaching Hospitals NHS Foundation TrustUniversity of SheffieldCompletedIdiopathic Pulmonary Arterial Hypertension | Chronic Thromboembolic Pulmonary HypertensionUnited Kingdom
-
China Academy of Chinese Medical SciencesGuang'anmen Hospital of China Academy of Chinese Medical SciencesCompletedHypertension, Resistant to Conventional Therapy | Primary HypertensionChina
-
Cytos Biotechnology AGCompletedMild Essential Hypertension | Moderate Essential HypertensionSwitzerland
Clinical Trials on Endovascular chemical ablation of adrenal gland
-
Third Military Medical UniversityUnknown
-
Third Military Medical UniversityRecruitingHypertension | Primary AldosteronismChina
-
Third Military Medical UniversityCompleted
-
Third Military Medical UniversityUnknown
-
Alberta Health servicesOttawa Hospital Research Institute; Jewish General Hospital; CancerCare Manitoba and other collaboratorsCompleted
-
Urological Research Network, LLCRecruitingMRI | Urinary Incontinence | Prostate Cancer | Ultrasound | Ablation | Sexual Function Disturbances | Prostate Biopsy | Adverse Effects Surgery | Urinary Function DisordersUnited States
-
The University of Hong KongRecruitingPain | Pancreatic Neoplasms | Pain Management | Cancer of Pancreas | Cancer-Associated PainHong Kong
-
University of AarhusAarhus University HospitalCompletedCarcinoma, Hepatocellular | Neuroendocrine TumorsDenmark
-
Third Military Medical UniversityCompletedResistant HypertensionChina