Clinical trial NCT04269928: Effects of Adrenal Artery Ablation and Adrenalectomy in Patients With Primary Aldosteronism
Official title: An Parallel Control Clinical Trail on Effects of Adrenal Artery Ablation and Adrenalectomy in Patients With Primary Aldosteronism
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Aldosteronism
Hypertension
Keywords: Primary Aldosteronism
Hypertension
Adrenal Artery Ablation
Adrenalectomy
Lead sponsor: Third Military Medical University
Sponsor class: OTHER
First posted: 2020-02-17
Enrollment: 110
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Chinese

Brief 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).


Eligibility criteria: 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

Primary outcomes:
measure: Change of office systolic and diastolic pressure
timeFrame: 52 weeks (End of Trial)
Secondary outcomes:
measure: Change of 24-h average systolic blood pressure
timeFrame: 52 weeks (End of Trial)
measure: Change of 24-h average diastolic blood pressure
timeFrame: 52 weeks (End of Trial)
measure: Change of home systolic and diastolic pressure
timeFrame: 52 weeks (End of Trial)
measure: Change of anti-hypertensive regimen
timeFrame: 52 weeks (End of Trial)
measure: Change of blood electrolytes（serum potassium and natrium in mmol/L）
timeFrame: 52 weeks (End of Trial)
measure: Change of aldosterone-to-renin ratio (ARR）
timeFrame: 52 weeks (End of Trial)
measure: Change of plasma aldosterone
timeFrame: 52 weeks (End of Trial)
measure: Change of plasma renin
timeFrame: 52 weeks (End of Trial)
measure: Change of plasma cortisol
timeFrame: 52 weeks (End of Trial)
measure: Change of serum creatinine
timeFrame: 52 weeks (End of Trial)
measure: Change of estimated glomerular filtration rate(eGFR)
timeFrame: 52 weeks (End of Trial)
measure: Change of 24-h urine microalbumin, microalbumin/creatinine ratio
timeFrame: 52 weeks (End of Trial)
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The third hospital affiliated to the Army Medical University
state: Chongqing
Study officials:
References: