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:

Rationale: Primary hyperaldosteronism (PA) is the most frequent and possibly curable form of secondary hypertension. The diagnosis and targeted treatment of PA is essential because of high vascular morbidity associated with PA as compared to essential hypertension with comparable blood pressure levels. PA is usually caused by either a unilateral aldosterone-producing adenoma (APA) or by bilateral adrenal hyperplasia (BAH). Distinction Between APA and BAH is critical since the former may be cured by adrenalectomy, and the latter needs life-long medical therapy with mineralocorticoid receptor antagonists (MRA).Studies demonstrate that adrenalectomy benefits also BAH patients with dominant nodule(s)producing the most of aldosterone excess. The distinction between unilateral and bilateral PAcan be made by adrenal vein sampling (AVS), as recommended by The Endocrine Society 2008 guideline. Currently, in Finland the diagnosis is based on computed tomography (CT) scanning which does not distinguish between aldosterone-producing and common non-functioning adrenal nodules and has limited accuracy detecting small adrenal masses. Since AVS is invasive,dependent on skilled radiologist and costly, there is a need for an accurate, non-invasive functional imaging such as 11C-metomidate positron emission tomography (MTO-PET).Objective: To assess diagnostic ability of MTO-PET as compared to AVS in PA. Secondary Objectives: To compare if standardized uptake values (SUVs)in MTO-PET imaging are similar histologically diagnosed nodular hyperplasia versus adenoma. To assess the diagnostic accuracy of adrenal CT as compared to MTO-PET and AVS. To assess the complete and partial remission rates (blood pressure response expressed in Daily Defined Dosages, medical therapy,use of potassium supplements) after allocating subjects to MRA-therapy or adrenalectomy at 1and 5 years.

Status: Completed     Trial Number: NCT01567111  
Conditions: Primary aldosteronism
Interventions: Procedure: 11C-Metomidate Positron Emission Tomography
Locations: Helsinki University Central Hospital, Helsinki, Finland, Tampere University, Tampere, Finland, University of Turku, Turku, Finland

Summary:

This is a Phase 2, randomized, placebo-controlled, multicenter, parallel-group, dose-ranging study in patients with PA to evaluate the efficacy and safety of up to 3 doses of CIN-107 as compared to placebo after 4 weeks of treatment.

Status: Recruiting     Trial Number: NCT04605549  
Conditions: Primary aldosteronism, Hyperaldosteronism
Interventions: Drug: CIN-107 Dose 1, Drug: CIN-107 Dose 2, Drug: CIN-107 Dose 3, Drug: Placebo for CIN-107
Locations: Birmingham, Alabama; Phoenix, Arizona; Greenbrae, California; San Francisco, California; Baltimore, Maryland; Ann Arbor, Michigan; Rochester, Minnesota; Houston, Texas

Summary:

In this prospective controlled cross over clinical trial, the investigators aim to evaluate the efficacy and safety of acetazolamide for the management of metabolic alkalosis inchildren with Bartter syndrome. Urine and blood electrolytes will be measured before and after acetazolamide treatment. The primary end point is a change in polyuria, hypokalemia,and metabolic alkalosis.

Status: Recruiting     Trial Number: NCT03847571  
Conditions: Bartter Syndrome
Interventions: Drug: Acetazolamide
Locations: Fateme Ghane Sharbaf, Mashhad, Iran, Islamic Republic of, Semnan University of Medical Sciences, Semnan, Iran, Islamic Republic of, Banafshe Dormansh, Tehran, Iran, Islamic Republic of, Simin Sadeghi, Zahedan, Iran, Islamic Republic of

Summary:

Primary aldosteronism (PA) is one of the most common cause of endocrine and resistant hypertension. Current studies have shown that the activation of the renin-angiotensin-aldosterone system (RAAS) and the increased sympathetic nerve activity in the central or local tissue are the key mechanisms of high blood pressure and its organ damages.The classical method for diagnosis of primary aldosteronism depends on the detection of peripheral venous blood aldosterone level, which is incapable of accurate positioning diagnosis. On the other hand, the current guidelines recommend that surgery and aldosterone receptor inhibitors were the only treatment for primary aldosteronism. However, only about 35% of aldosterone tumors and a small part of unilateral adrenal hyperplasia can be treated by surgery. More than 60% of idiopathic aldosteronism and bilateral adrenal hyperplasia need long-term drug therapy. However, long-term aldosterone inhibitor treatment may also cause hyperkalemia, male breast hyperplasia, female hirsutism and other adverse reactions.Therefore, the investigators proposed that endovascular chemical partial ablation of the adrenal gland can lower the aldosterone level, reduce the blood pressure and recover the potassium metabolism balance. In order to confirm the above effects, the investigators conduct an open, prospective, positive controlled study in patients with primary aldosteronism patients (including aldosterone, idiopathic aldosteronism and adrenal hyperplasia). The effects on blood pressure, blood electrolytes, adrenal hormones, metabolic indexes, target organ damages were observed to explore the efficacy and safety of the endovascular ablation of the adrenal gland in the treatment of primary aldosteronism.

Status: Unknown     Trial Number: NCT03653845  
Conditions: Primary aldosteronism, Hypertension
Interventions: Procedure: Endovascular chemical Ablation of Adrenal Gland|Drug: Sequenced antihypertensvie drugs with titrated dosage
Locations: The third hospital affiliated to the Third Military Medical University, Chongqing, Chongqing, China, The third hospital affiliated to the Third Military Medical University, Chongqing, China

Summary:

Primary aldosteronism (PA) is the most common endocrine cause of resistant hypertension. Surgery and medicine are the main treatment for PA by the current guidelines. However,only a small part of patients with PA meet the surgical criteria, and most of them have to take spironolactone or other antihypertensive drugs for long time. On the other side, long-term inhibition of aldosterone receptor may cause hyperkalemia, male breast hyperplasia and other adverse reactions. Moreover, hyperaldosterone is still not corrected by spironolactone, which cause extensive cerebrovascular damages even though blood pressure and blood potassium had been normalized.

With the development of adrenal vein sampling and adrenal ablation, the precise diagnosis and treatment of PA is possible. Selective adrenal artery ablation (AAA) was observed with significant decrease of blood aldosterone and blood pressure in patients with PA, which made it promising that primary aldosteronism with resistant hypertension could be relieved by adrenal artery ablation.

Status: Completed     Trial Number: NCT04345198  
Conditions: Resistant Hypertension
Interventions: Procedure: Adrenal Artery Ablation
Locations: The third hospital affiliated to the Third Military Medical University, Chongqing, China, 400042

Summary:

The pathogenesis of adrenal tumors is still not fully elucidated and the treatment options for malignant tumors are poor. The current study investigates different aspects of the pathogenesis of adrenal tumors and evaluates different therapeutic options in patients with adrenocortical carcinoma.

Status: Recruiting     Trial Number: NCT00669266  
Conditions: Adrenal Tumors, Adrenocortical Carcinoma, Conn’s Syndrome, Cushing’s Syndrome, Pheochromocytoma
Interventions: Observational only
Locations: University of Wuerzburg, Wuerzburg, Germany

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

©2021 Primary Aldosteronism Foundation

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