Clinical Studies

Clinical studies  are the cornerstone of medical knowledge. By taking part in clinical research, patients get the opportunity to improve their own health while impacting the care of others.

The Primary Aldosteronism Foundation fosters research worldwide, and encourages everyone in the PA patient community to participate in clinical research. Below is the list of all clinical studies referenced by ClinicalTrials.gov under primary aldosteronism. The list includes all published studies and is updated as soon as they are made public. Click on the title of any study to be taken to a web page with full details on the US National Library of Medicine website.

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Summary:

In this study, the investigators will compare endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) treatment in patients with primary aldosteronism (PA) with lateralization of their aldosterone overproduction to their left adrenal and a left-sided tumour visible by EUS, with conventional unilateral adrenalectomy. The primary objective of the study is to evaluate biochemical and clinical outcome after EUS-RFA treatment compared with unilateral adrenalectomy. Secondary objectives are to compare safety/procedural complications of the two procedures, length of hospital stay, rate of postoperative hypoaldosteronism and hypocortisolism after treatment, and change health-related quality of life compared with pre-treatment.

Status: Not yet recruiting     Trial Number: NCT05368090  
Conditions: Primary aldosteronism, Aldosterone-Producing Adenoma
Interventions: Procedure: EUS-RFA of left adrenal gland, Procedure: adrenalectomy
Locations: Haukeland University Hospital, Norway

Summary:

Elevated aldosterone levels were also shown to contribute to the excess morbidity and mortality. Literature shows aldosterone and renin levels differ between ethnicity and gender. There is no established reference intervals for these two hormone levels in Asian community. We aim to establish reference intervals for plasma aldosterone and direct renin concentrations among Malaysians residing in Sarawak using the chemiluminescent immunoassay (CLIA). This is a cross-sectional study which will be conducted among ambulatory patients, healthy blood donors and healthy volunteers. 300 participants who fulfil study criteria will be recruited after informed consent.

Socio-demographic data and anthropometric measurements will be recorded. Blood will be taken for plasma aldosterone, renin, serum potassium and creatinine. Urine will be collected for estimation of 24-hour sodium excretion. Aldosterone and renin reference intervals will be established partitioned for gender.

Status: Recruiting     Trial Number: NCT05232162  
Conditions: Aldosteronism
Interventions: None: observational
Locations: Universiti Malaysia Sarawak, Kuching, Sarawak, Malaysia, 93350

Summary:

Superselective adrenal artery embolization (SAAE) has been used as a minimally invasive alternative for the treatment of adrenal tumors. The clinical efficacy of SAAE has been proved by a number of clinical studies. Since the efficacy and safety of SAAE was justified by the treatment of adrenal tumors and APA, we hypothesized that SAAE might cause a significant reduction of blood pressure in cases of hypertension caused by bilateral IHA. Here, we intend to conduct a prospective cohort study to demonstrate the efficacy and safety of SAAE for bilateral IHA with a one-month follow-up.

Status: Not yet recruiting     Trial Number: NCT05186675  
Conditions: Primary aldosteronism due to adrenal hyperplasia (bilateral)
Interventions: Procedure: superselective adrenal arterial embolization
Locations: Second Affiliated Hospital of Nanchang University, Nanchang, China

Summary:
In order to meet all the challenges in the diagnosis and treatment of adrenal diseases in China, CASE was founded in 2020. With advanced medical equipment and Internet of Things (IoT) technology, CASE is committed to creating an online and offline integrated solution for adrenal disease, and for the entire spectrum of adrenal disease, to achieve a more convenient and precise model of care for patients, aiming to establish a platform with diagnosis and treatment of adrenal disease and their long-term follow-up. It allows the application and evaluation of treatment strategies at these centers.

Status: Recruiting     Trial Number: NCT04890444  
Conditions: Cushing Syndrome, Aldosteronism, Hypoadrenalism, Congenital Adrenal Hyperplasia, Adrenal Adenoma, Adrenal Incidentaloma, Adrenal Carcinoma, Pheochromocytoma,, Primary aldosteronism
Interventions: Observational Only
Locations: Shanghai Jiao Tong University School of Medicine, Shanghai, China

Summary:

This is a prospective study. We will enroll 100 patients with definite diagnosis of PA using adrenal venous sampling (AVS) as the gold standard for subtype to evaluate the value of 68Ga-pentixa for PET/CT in the diagnosis of PA.

Status: Recruiting     Trial Number: NCT05131061  
Conditions: Primary aldosteronism
Interventions: Diagnostic Test: Aldosterone/renin ratio(ARR) testing
Locations: The First Affiliated Hospital of Chongqing Medical University, Chongqing, China

Summary:

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.

Status: Recruiting     Trial Number: NCT04991961  
Conditions: Primary aldosteronism, hypertension
Interventions: Diagnostic Test: withdraw antihypertensive drugs
Locations: Qifu Li, Chongqing, Chongqing, China; The First Affiliated Hospital of Chongqing Medical University, Chongqing, Chongqing, China

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The Primary Aldosteronism Foundation is a registered 501(c)(3) public charity. Donations are tax deductible in the US.

©2021-22
Primary Aldosteronism Foundation

The Primary Aldosteronism Foundation is a registered 501(c)(3) public charity. Donations are tax deductible in the US.

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