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 study was proposed to include 20 patients with clinical suspicion of primary aldosteronism for [18F]AlF-NOTA-pentixather PET/CT imaging and to analyze the specificity and sensitivity of [18F]AlF-NOTA-pentixather PET/CT for the diagnosis of APA by comparison with the final pathological findings.

Status: Recruiting     Trial Number: NCT05815069  
Conditions: Aldosterone-Producing Adenoma
Interventions: Diagnostic Test: [18F]AlF-NOTA-Pentixather PET/CT
Locations: Sichuan Academy of Medical Sciences, Sichuan Provincial People’s Hospital, Chengdu, China

Summary:

There is no debate that ACTH stimulation increases the selectivity index (SI) and, therefore, greatly increases the likelihood of successful AVS. However, the effect of ACTH stimulation on the lateralization index (LI) is controversial, with several studies reporting a reduction in the proportion of lateralized AVS results and, therefore, of surgically treatable patients. Hitherto, most of the studies on the value of using ACTH stimulation in AVS are retrospective studies with a small sample size, or multi-center studies with ununified methods of ACTH stimulation and evaluation standards of results. Therefore, there are obvious heterogeneity in the results and the value of evidence is limited. In this prospective study, we analyzed the SI and LI in simultaneous bilateral AVS at baseline and after ACTH stimulation in our center, and further estimated the prognosis of patients underwent adrenalectomy with different cut-off points of LI after ACTH stimulation. Present study will provide novel evidence for the value of ACTH stimulation in AVS and improve AVS procedure.

Status: Recruiting     Trial Number: NCT05826080  
Conditions: Primary aldosteronism
Interventions: Procedure: Adrenal Venous Sampling
Locations: Drum Tower Hospital affiliated to Nanjing University Medical School, Nanjing, China

Summary:

Primary aldosteronism (PA) is thought to be the most common secondary endocrine form of hypertension. Compared with patients with essential hypertension with similar blood pressure, patients with PA have significantly higher atrial fibrillation, myocardial infarction, heart failure, stroke, deterioration of renal function and all-cause mortality. Therefore, early and systematic implementation of effective surgical or medical treatment is essential to prevent or reverse the excess vascular events and mortality of these patients. The patients with bilateral PA were mainly treated with mineralocorticoid receptor antagonists (MRAs). The MRA spironolactone is effective at lowering BP and reversing the harmful metabolic consequences, but its use is limited by adverse effects such as gynaecomastia, mastodynia, menstrual abnormalities and impotence due to its agonist activity at the progesterone receptor and antagonist activity at the androgen receptor. Finerenone is claimed to be a more selective blocker of the mineralocorticoid receptor than spironolactone being associated with fewer antiandrogenic side-effects. In this study, we will compare the efficacy, safety and tolerability of finerenone versus spironolactone in patients with hypertension associated with primary aldosteronism.

Status: Not yet recruiting     Trial Number: NCT05814770  
Conditions: Primary aldosteronism, hypertension
Interventions: Drug: Finerenone, Drug: Spironolactone
Locations: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Nanjing, China

Summary:

The mission of this project is to increase the detection of Primary Aldosteronism (PA), the most common cause of secondary hypertension, which can either be cured surgically or treated with targeted medications. This is a prospective specimen collection cohort study aimed to increase the detection of primary aldosteronism (PA) in patients with hypertension. Study samples will be obtained longitudinally. One collection of plasma will be obtained. Blood draw may need to be repeated in some subjects after washout period. Study will continue for a period or 1 year, with plan to enroll around 50 subjects.

Status: Not yet recruiting     Trial Number: NCT05757076  
Conditions: Primary aldosteronism
Interventions: Procedure: Blood test for calculating aldosterone and renin ratio (ARR)
Locations: The Cleveland Clinic Foundation, Cleveland, Ohio, USA

Summary:

This is a prospective randomized controlled trial where quality of life and the effectiveness of treatment will be evaluated in 80 patients with confirmed unilateral primary aldosteronism, randomly assigned to be either treated surgically with unilateral adrenalectomy or to receive medical treatment with eplerenone.

Status: Not yet recruiting     Trial Number: NCT05797558  
Conditions: Primary aldosteronism due to adenoma
Interventions: Procedure: Unilateral adrenalectomy; Drug: Medical treatment (eplerenone
Locations: University of Gothenburg, Gothenburg, Sweden; Karolinska University Hospital, Stockholm, Sweden; Umeå University, Umeå, Sweden

Summary:

Elevated aldosterone causes a moderate to severe increase in blood pressure, and leads to various target organ damage including cardiovascular ones. Aldosterone has been considered one of the important risk factors for cardiovascular and cerebrovascular diseases. Currently, the use of mineralocorticoid receptor antagonists (MRA) has been proven to reduce blood pressure levels, but long-term prognostic data are lacking in hypertensive patients. Therefore, the purpose of this clinical trial is to assess the effect of MRA on cardiovascular disease in patients with Hypertension and Hyperaldosteronemia.

Status: Not yet recruiting     Trial Number: NCT05688579  
Conditions: Hypertension, Hyperaldosteronemia (hyperaldosteronism)
Interventions: Drug: Spironolactone. Drug: Finerenone. Other: Blank control
Locations: People’s Hospital of Xinjiang, Uygur Autonomous Region, China