NCT04409431 Effects of Adrenal Artery Ablation and Spironolactone in Patients With Primary Aldosteronism
| NCT ID | NCT04409431 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Third Military Medical University |
| Condition | Primary Aldosteronism |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2019-12-01 |
| Primary Completion | 2024-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2019-12-01 with a primary completion date of 2024-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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. Current guidelines suggest that surgery and aldosterone receptor inhibitors are the only treatment for primary aldosteronism. However, only about 35% of aldosterone tumors and a small number of unilateral adrenal hyperplasia can be treated surgically. More than 60% of primary aldosteronism and bilateral adrenal hyperplasia need long-term oral aldosterone receptor inhibitors. At present, spironolactone is the most commonly used aldosterone receptor inhibitor. Long term use of spironolactone may cause hyperkalemia, hyperplasia of male mammary gland, hairiness of female and other adverse reactions. Therefore, the researchers suggest that partial removal of adrenals can reduce aldosterone level, lower blood pressure and restore potassium metabolism balance. In patients with primary hyperaldosteronism, the level of aldosterone increases, which can cause vascular endothelial dysfunction, myocardial injury and ventricular fibrosis. The study shows that long-term oral administration of spironolactone can reverse the above cardiovascular damage and correct heart failure. Adrenal artery ablation can reduce aldosterone level, but the long-term effect on cardiovascular system is unknown. In order to confirm the effect of adrenal artery ablation on blood pressure and cardiovascular system, the researchers conducted an open cohort study on patients with primary aldosteronism (including aldosterone, idiopathic aldosteronism and adrenal hyperplasia). To observe the effect of adrenal artery ablation and spironolactone on blood pressure, blood electrolyte, metabolic index, cardiovascular events and cardiovascular death risk in patients with primary aldosteronism, and to explore its efficacy and safety.
Eligibility 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
Contact & Investigator
Zhu ZM, MD
STUDY DIRECTOR
The third militery medical university
Frequently Asked Questions
Who can join the NCT04409431 clinical trial?
This trial is open to participants of all sexes, aged 30 Years or older, up to 60 Years, studying Primary Aldosteronism. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04409431 currently recruiting?
Yes, NCT04409431 is actively recruiting participants. Contact the research team at yslimiss@163.com for enrollment information.
Where is the NCT04409431 trial being conducted?
This trial is being conducted at Chongqing, China.
Who is sponsoring the NCT04409431 clinical trial?
NCT04409431 is sponsored by Third Military Medical University. The principal investigator is Zhu ZM, MD at The third militery medical university. The trial plans to enroll 60 participants.