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Primary Aldosteronism clinical trials

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NCT ID: NCT06100367 Recruiting - Clinical trials for Primary Aldosteronism

11C-Metomidate PET/CT for Endocrine Hypertension and Characterisation of Adrenal Tumours

Start date: December 30, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

- 10% of patients with hypertension potentially have the treatable condition - primary aldosteronism (PA). This is caused by either bilateral adrenal disease (~40%), managed with lifelong medications; or unilateral disease (~60%), cured with laparoscopic surgery (adrenalectomy). Current diagnosis of PA includes a screening test with aldosterone-renin ratio, followed by a confirmatory salt loading test (in most patients) to demonstrate unsuppressed aldosterone levels. Of note, some patients with suppressed aldosterone after confirmatory tests (also termed low-renin hypertension) may also have unilateral adrenal tumors. - The difficulty with identifying curable unilateral disease is due to adrenal vein sampling (AVS): an invasive, and technically-difficult procedure. An alternative novel imaging, 11C-Metomidate Positron emission tomography-computed tomography (PET-CT), can detect adrenal tumors which are over-producing aldosterone. It is non-invasive, non-operator-dependent, and potentially may identify more patients with curable unilateral disease. The results from our pilot study in 25 patients with confirmed PA (ClinicalTrials.gov NCT03990701, PA_CURE) showed that 11C-Metomidate PET-CT exhibited comparable performance to AVS in subtyping PA, and this should be validated in a larger study. - In addition, 11C-Metomidate is also able to differentiate adrenocortical lesions in the adrenal gland from other lesions found in adrenal tissue, such as adrenomedullary lesions (e.g. pheochromocytoma). - Hence, the investigators hypothesize that 11C-metomidate PET-CT can accurately (1) identify patients with surgically curable unilateral adrenal disease among hypertensive Asians with primary aldosteronism (PA_CURE 2 / PA_MTO EH study) and (2) differentiate adrenocortical lesions from other lesions in patients with adrenal tumors (PA_MTO AT study)

NCT ID: NCT06076473 Recruiting - Clinical trials for Primary Aldosteronism

Untargeted Metabolomics for Primary Aldosteronism

PUMPAP
Start date: January 19, 2023
Phase:
Study type: Observational

Primary aldosteronism (PA) is a common and likely under-diagnosed cause of secondary hypertension with associated cardiovascular morbidity and mortality. Current diagnosis comprises screening, confirmatory testing and sub-type classification (lateralisation) to distinguish unilateral disease (requiring surgery) from bilateral disease (requiring medical management). This multi-step process is complex and variable with a lack of uniformity in diagnostic protocols, standardised/reference assay methodologies, and diagnostic thresholds. There is evidence in the literature that targeted serum steroid panels may have a role in diagnosis of PA, and both targeted steroid panels and untargeted metabolomics in serum and urine are a promising area of research. This study aims to identify and recruit participants (n=40; 20 with confirmed PA and 20 with other causes of hypertension) willing to donate lithium heparin plasma for a metabolomics pilot study. This plasma will be interrogated through untargeted metabolomics using gas/liquid chromatography-mass-spectrometric methods and computational data processing to allow power calculations and inform experimental design for future studies. The utility of metabolites from the metabolomics dataset will be evaluated by comparison against current biomarkers for screening, diagnosis and lateralisation as well as radiology and histology acquired through routine diagnostic work-up. The long-term aim for larger studies is to identify suitable candidate analytes in plasma for future development into targeted, clinically-useful analyte panels.

NCT ID: NCT06068101 Completed - Clinical trials for Primary Aldosteronism

Clinical and Genetic Investigation of the Association Between Primary Aldosteronism and Thyroid Cancer

Start date: March 1, 2019
Phase:
Study type: Observational

Aldosterone excess can cause oxidative stress leading to DNA damage in vitro and in vivo. Single case reports demonstrated a coincidence of primary aldosteronism (PA) with different malignancies. A higher prevalence of thyroid nodules and non-toxic multinodular goiter was described in patients with PA compared to those with essential hypertension (EH). A single study showed an association between PA and papillary thyroid cancer (PTC), but without a paired control group. Objective: To assess PA prevalence in a transversal cohort of patients with PTC and EH compared to a paired control group with HT.

NCT ID: NCT06047912 Recruiting - Hypertension Clinical Trials

Screening for Primary Aldosteronism in Hypertension With 24-hour URinary aLdosterone

PURL
Start date: September 15, 2023
Phase:
Study type: Observational

This is an observational study compares the positivity rates of two tests for screening for primary aldosteronism: plasma aldosterone renin ratio and 24-hour urine aldosterone in patients with young-onset hypertension with or without other clinical features of primary aldosteronism.

NCT ID: NCT05973604 Recruiting - Atrial Fibrillation Clinical Trials

Prevalence of Primary Aldosteronism in Atrial Fibrillation

ERETRIA
Start date: September 1, 2021
Phase:
Study type: Observational

This is an observational prospective cross-sectional study, investigating the prevalence of primary aldosteronism in patients with atrial fibrillation.

NCT ID: NCT05959863 Recruiting - Clinical trials for Primary Aldosteronism

Primary Aldosteronism LC-MS/MS-specific Cutoffs

PM
Start date: August 30, 2023
Phase:
Study type: Observational

Aims to evaluation the LC-MS/MS-specific cutoffs of PA screening and CCT test.

NCT ID: NCT05925569 Not yet recruiting - Hypertension Clinical Trials

Electronic Alert to Improve Testing For Primary Aldosteronism in Patients With Hypertension

ALERT-PA
Start date: December 2023
Phase: N/A
Study type: Interventional

Primary aldosteronism (PA) is common but rarely recognized cause of hypertension that carries excess cardiovascular and renal risk and has approved targeted treatments. Despite current clinical guidelines that recommend screening in a defined set of high-risk populations, less than 5% of eligible patients are ever screened for PA. This study aims to evaluate the impact of a computer decision support Best Practice Advisory (BPA) alert on rates of screening for PA in guideline-eligible patients, referral to specialist PA care, and treatment with mineralocorticoid receptor antagonists.

NCT ID: NCT05924620 Recruiting - Clinical trials for Primary Aldosteronism

Efficacy and Safety of Finerenone in Patients With Primary Aldosteronism

Start date: June 20, 2023
Phase: Phase 4
Study type: Interventional

To study the efficacy and safety of finerenone in patients with primary aldosteronism

NCT ID: NCT05826080 Recruiting - Clinical trials for Primary Aldosteronism

Effect of Adrenocorticotropic Hormone Stimulation During Adrenal Vein Sampling in Primary Aldosteronism

Start date: September 1, 2021
Phase:
Study type: Observational

The purpose of our research is to evaluate the value of ACTH stimulation in AVS especially in lateralization is still controversial.

NCT ID: NCT05814770 Not yet recruiting - Hypertension Clinical Trials

Comparing the Efficacy and Safety of Finerenone and Spironolactone in the Treatment of Primary Aldosteronism

Start date: May 2023
Phase: Phase 4
Study type: Interventional

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.