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:

This is a phase II study (with targeted recruitment of 30 participants) designed to evaluate the accuracy of a novel radiopharmaceutical tracer, para-chloro-2-[18F]fluoroethyl etomidate (CETO), used with positron emission tomography (PET) and computed tomography (CT), as a way to subtype unilateral vs. bilateral forms of Primary Aldosteronism, compared to AVS as a reference gold standard. Subjects consenting to study participation will receive the [18-F] CETO followed by the PET/CT scan.

Status: Not yet recruiting     Trial Number: NCT05472493  
Conditions: Primary aldosteronism
Interventions: Biological: [18-F]CETO
Locations: University of Calgary, Calgary, Alberta, Canada

Summary:

Sudden Cardiac Death is a leading cause of mortality and remains a major public health burden worldwide. Cardiac arrest due to coronary heart disease explains a large proportion of the cases, but if autopsy is not performed the exact underlying cause remains obscure in many adults who face sudden death outside heath care organizations. The investigators aim to find proof that primary aldosteronism is a risk factor for sudden death and to characterize the prevalence of adrenal pathology in sudden death of undetermined cause in a case-control study. In addition, the study aims to characterize the prevalence of other adrenal pathology (i.e., silent adenomas, cortisol-producing adenomas and pheochromocytomas) in sudden death. The investigators also seek evidence that other endocrine hormone overproduction-causing diseases are more prevalent in persons with sudden death compared with those experiencing traumatic or suicidal death sudden death.

Status: Recruiting     Trial Number: NCT05446779  
Conditions: Primary aldosteronism, Adrenal Cushing Syndrome, Pheochromocytoma, Endocrine Neoplasia
Interventions: Diagnostic Tests: Adrenal aldosterone synthase (CYP11B2) staining, Adrenal cortisol synthase (CYP11B1) staining, Histopathological analysis
Locations: Endocrinology, Helsinki University Hospital and University of Helsinki, Helsinki, Finland

Summary:

During routine subtyping of confirmed primary aldosteronism by adrenal vein sampling extra plasma samples are drawn from both renal veins and from inferior vena cava. Plasma renin concentration and renin activity are analyzed from these samples. Adrenal computed tomographies are analyzed for cysts and other possible pathology by a blinded radiologist. Aim is to evaluate correlation between renal pathology and renin measurements.

Status: Completed     Trial Number: NCT05435703  
Conditions: Primary aldosteronism
Interventions: Observational only
Locations: Tampere University Hospital, Tampere, Finland

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