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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04269928
• Other study ID #: Quadruple A -PA
• Status: Completed
• Start date: January 19, 2016
• Est. completion date: June 1, 2021

Study information

• Verified date: March 2024
• Source: Third Military Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: June 1, 2021
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

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 ?-? 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

Related Conditions & MeSH terms

• Hyperaldosteronism
• Hypertension
• Primary Aldosteronism

Intervention

Procedure:
• Endovascular chemical ablation of adrenal gland
Patients in this group will be treated with ablation of adrenal gland by endovascular injection of dehydrated alcohol

Locations

Country	Name	City	State
China	The third hospital affiliated to the Army Medical University	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Third Military Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of office systolic and diastolic pressure	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	Change of 24-h average systolic blood pressure	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)
Secondary	Change of 24-h average diastolic blood pressure	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)
Secondary	Change of home systolic and diastolic pressure	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)
Secondary	Change of anti-hypertensive regimen	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)
Secondary	Change of blood electrolytes(serum potassium and natrium in mmol/L)	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)
Secondary	Change of aldosterone-to-renin ratio (ARR)	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)
Secondary	Change of plasma aldosterone	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)
Secondary	Change of plasma renin	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)
Secondary	Change of plasma cortisol	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)
Secondary	Change of serum creatinine	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)
Secondary	Change of estimated glomerular filtration rate(eGFR)	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)
Secondary	Change of 24-h urine microalbumin, microalbumin/creatinine ratio	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)