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:

The human gut microbiome has been associated with many health factors but variability between studies limits the exploration of effects between them. This study aims to systematically characterize the gut microbiota of various critical chronic diseases, compare the similarities and differences of the microbiome signatures linked to different regions and diseases, and further investigate their impacts on microbiota-based diagnostic models.

Status: Recruiting     Trial Number: NCT05638269  
Conditions: Essential Hypertension,Liver Cancer, Nasopharyngeal Cancer, Pancreatic Cancer, Lung Cancer, Chronic Kidney Diseases, Acute Coronary Syndrome, Epilepsy Gastric Cancer Primary Aldosteronism Subclinical hypothyroïdism
Interventions:
Locations: 50 study locations throughout China. See link for full details.

Summary:

Collaborative work within 2 hospitals at the CHU of Caen, at the CHRU of Lille, concerning the evaluation of the biological markers of primary hyperaldosteronism (PAH) with the dosage of aldosterone in LC -MS/MS, which is performed in both centers, with two different techniques. The main objective is to define the range of Aldosterone concentrations in LC MS/MS, of renin in an automated method, in populations of healthy volunteers, essential hypertensives, and hypertensives with primary hyperaldosteronism, in order to establish a threshold for the screening of PAH by the renin-aldosterone-ratio (RAR), and for the confirmation of PAH by a dynamic test with an Aldosterone threshold post salt load test.

Status: Recruiting     Trial Number: NCT05640128  
Conditions: Primary aldosteronism
Interventions: Other: Aldosterone in HPLC-MS/MS
Locations: CAEN University Hospital, Caen, France

Summary:

he study aims to assess the effect of superselective adrenal arterial embolization on vascular endothelial function in patients with primary aldosteronism based on brachial artery flow-mediated relaxation.

Status: Recruiting     Trial Number: NCT05561361  
Conditions: Primary aldosteronism
Interventions: Procedure: Super selective adrenal artery embolization, Drug: Spironolactone
Locations: The Second Affiliated Hospital of Nanchang University, Nanchang, China

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