Hypertension Clinical Trial
Official title:
An Open-label, Cohort Study on Effects and Long-term Prognosis of Adrenal Artery Ablation and Spironolactone in Patients With Primary Aldosteronism
NCT number | NCT04409431 |
Other study ID # | AAA-S |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | December 1, 2019 |
Est. completion date | June 1, 2023 |
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | June 1, 2023 |
Est. primary completion date | December 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 30 Years to 60 Years |
Eligibility |
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 ?-? 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 |
Country | Name | City | State |
---|---|---|---|
China | The third hospital affiliated to the Army Medical University | Chongqing | Chongqing |
Lead Sponsor | Collaborator |
---|---|
Third Military Medical University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change of office systolic and diastolic pressure compared with the baseline between two groups | Change of office systolic and diastolic pressure compared with the baseline between the intervention and control group at the end of the study | 3 years(End of Trial) | |
Primary | Incidence of major adverse cardiac events (MACE)(%) between two groups | Incidence of major adverse cardiac events (MACE)(%)(cardiac death, myocardial infarction and target vessel revascularisation) between two groups at the end of the study | 3 years(End of Trial) | |
Secondary | Change of 24-h average systolic blood pressure between two groups | Change of 24-h average systolic blood pressure between two groups at end of the study | 3 years(End of Trial) | |
Secondary | Change of 24-h average diastolic blood pressure between two groups | Change of 24-h average diastolic blood pressure between two groups at end of the study | 3 years(End of Trial) | |
Secondary | Change of parameters assessed by echocardiography (IVSd?IVSs?LVPWd, LVPWs, LVEDD, LVEF, LVM) between two groups | Change of parameters assessed by echocardiography (IVSd?IVSs?LVPWd, LVPWs, LVEDD, LVEF, LVM) between two groups at end of the study | 3 years(End of Trial) | |
Secondary | Change of carotid intima-media thickness assessed by carotid ultrasound between two groups | Change of carotid intima-media thickness assessed by carotid ultrasound between two groups at end of the study | 3 years(End of Trial) |
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