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Primary Aldosteronism clinical trials

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NCT ID: NCT05405101 Recruiting - Clinical trials for Primary Aldosteronism

Randomised Trial Comparing Thermal Ablation With Adrenalectomy in the Treatment of Unilateral Asymmetric PA

WAVE
Start date: September 1, 2022
Phase: N/A
Study type: Interventional

The primary objective of WAVE is to test the hypothesis that thermal ablation (microwave or RFA) is non-inferior to surgery in the biochemical (and if so, in the clinical) cure of unilateral PA, according to the international consensus PASO criteria. Secondary objectives are to determine whether either intervention is superior to the other in relation to the following outcomes. Where no superiority of either intervention is established, non-inferiority of thermal ablation against adrenalectomy will be sought. - Frequency and severity of adverse events - Length of inpatient stay - Patient satisfaction - Quality of life - Return to activities of daily living An additional secondary objective in the thermal ablation group alone will be anatomical efficacy of ablation.

NCT ID: NCT05368090 Recruiting - Clinical trials for Primary Aldosteronism

Endoscopic Ultrasound-guided Radiofrequency Ablation in Primary Aldosteronism

Start date: June 3, 2022
Phase: N/A
Study type: Interventional

In this study, the investigators will perform endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) treatment of left-sided adrenal tumours in patients with primary aldosteronism (PA) and in patients with mild autonomous cortisol secretion (MACS). Four different study groups will all receive EUS-RFA of left-sided adrenal tumours. Clinical and biochemical outcome as well as procedural safety will be evaluated. In study patients with verified lateralised aldosterone or cortisol overproduction to the left adrenal, outcome will be compared with control groups performing conventional unilateral adrenalectomy. Study group 1: PA patients with AVS-verified left sided lateralisation and a EUS-detectable tumour in the left adrenal for EUS-RFA treatment. Study group 2: PA patient with suspected left-sided overweight of aldosterone production and a EUS-detectable tumour but without strict lateralisation of their aldosterone overproduction, for EUS-RFA treatment as an aldosterone "debulking" procedure. Study group 3: patients with MACS with AVS-verified lateralisation of cortisol overproduction to the left adrenal and EUS-detectable tumour for EUS-RFA treatment Study group 4: patients with MACS with bilateral adrenal tumours and verified bilateral overproduction of cortisol for EUS-RFA treatment as a cortisol "debulking" procedure.

NCT ID: NCT05030545 Recruiting - Hypertension Clinical Trials

Cardiovascular Manifestations of MR Activation in Primary Aldosteronism: Pilot Clinical Study

Start date: December 15, 2022
Phase: Phase 4
Study type: Interventional

This research study aims to learn more about the impact the hormone aldosterone on the heart. Primary aldosteronism is a condition where the body's adrenal glands make too much of the hormone aldosterone, which can cause high blood pressure and increase the risk of heart and kidney disease. Treatment with medications that block aldosterone can reduce that risk. This study is trying to learn whether treatment with a medication that blocks aldosterone can improve heart function in people who make too much aldosterone.

NCT ID: NCT04991961 Recruiting - Hypertension Clinical Trials

Effect of Anti-hypertensive Medications on the Diagnostic Accuracy in Screening for Primary Aldosteronism

HASA
Start date: September 15, 2020
Phase:
Study type: Observational

To evaluate the effect of anti-hypertensive medication on efficiency of primary aldosteronism screening test, and to determine the appropriate diagnostic cutoff value for Chinese hypertension patients during antihypertensive drugs therapy.

NCT ID: NCT04529018 Recruiting - Clinical trials for Primary Aldosteronism

CETO First in Human Trial

CETO
Start date: August 3, 2020
Phase: N/A
Study type: Interventional

The study is a Phase 1, single-centre, open label, micro-dosing study. The aim is to investigate an innovative new tracer, [18F]CETO, as a potential alternative to adrenal vein sampling for the lateralisation of primary aldosteronism (PA).

NCT ID: NCT04428827 Recruiting - Clinical trials for Primary Aldosteronism

Outcome of Patients With Primary Aldosteronism

PA_Outcome
Start date: October 1, 2016
Phase:
Study type: Observational

Majority of patients with hypertension have primary hypertension (without an underlying cause). Primary aldosteronism (PA) is the most common cause of secondary hypertension, and can be found in 5-10% of patients locally. PA is caused by excessive release of a hormone (aldosterone) from the adrenal glands, which can be unilateral (one gland) or bilateral (both glands). It has been shown that excess aldosterone has other harmful effects in addition to hypertension, such as directly affecting the heart, blood vessels, kidneys, leading to increased cardiovascular morbidity and mortality. This is supported by studies showing reversal of these effects after treatment for PA. The investigators aim to assess the long-term cardiovascular, and renal outcomes of patients with PA, compared to patients with essential hypertension.

NCT ID: NCT04422756 Recruiting - Clinical trials for Primary Aldosteronism

Prospective Evaluation of Confirmatory Testing For Primary Aldosteronism

Start date: January 15, 2017
Phase:
Study type: Observational

This study is to evaluate the performance characteristics of the seated saline infusion test and the ultra low-dose ACTH stimulation test for the diagnosis of primary aldosteronism.

NCT ID: NCT04409431 Recruiting - Hypertension Clinical Trials

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

Start date: December 1, 2019
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT04213963 Recruiting - Atrial Fibrillation Clinical Trials

Prospective Study on Primary Aldosteronism in Resistant Hypertension

PrePARe
Start date: September 1, 2011
Phase:
Study type: Observational

Prevalence of primary aldosteronism (PA) in resistant hypertension is not clear. In addition, emerging evidence supports the role of elevated serum aldosterone in promoting cardiovascular disease, independently from high blood pressure (BP) levels, but current data on this issue are heterogeneous.

NCT ID: NCT03653845 Recruiting - Hypertension Clinical Trials

Adrenal Artery Ablation for Primary Aldosteronism

Start date: July 1, 2018
Phase: Phase 3
Study type: Interventional

Primary aldosteronism (PA) is one of the most common causes 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. The classical method for diagnosis of primary aldosteronism depends on the detection of peripheral venous blood aldosterone level, which is incapable of accurate positioning diagnosis. On the other hand, the current guidelines recommend that surgery and aldosterone receptor inhibitors were the only treatment for primary aldosteronism. However, only about 35% of aldosterone tumors and a small part of unilateral adrenal hyperplasia can be treated by surgery. More than 60% of idiopathic aldosteronism and bilateral adrenal hyperplasia need long-term drug therapy. However, long-term aldosterone inhibitor treatment may also cause hyperkalemia, male breast hyperplasia, female hirsutism and other adverse reactions. Therefore, the investigators proposed that endovascular chemical partial ablation of the adrenal gland can lower the aldosterone level, reduce the blood pressure and recover the potassium metabolism balance. In order to confirm the above effects, the investigators conduct an open, prospective, positive controlled study in patients with primary aldosteronism patients (including aldosterone, idiopathic aldosteronism and adrenal hyperplasia). The effects on blood pressure, blood electrolytes, adrenal hormones, metabolic indexes, target organ damages were observed to explore the efficacy and safety of the endovascular ablation of the adrenal gland in the treatment of primary aldosteronism.