Clinical Research Directory

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

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.

Kidney Stiffness Measured by Ultrasound in Patients With High Blood Pressure and Healthy Volunteers

High blood pressure (hypertension) is a leading cause of kidney damage, but detecting early kidney changes remains challenging with currently available tools. This study investigates whether kidney stiffness, measured by a non-invasive ultrasound technique called shear wave elastography (SWE), differs across different subtypes of hypertension and healthy volunteers, and whether it may serve as an early marker of hypertension-related kidney damage. Adults with essential hypertension, renovascular hypertension, and primary aldosteronism, as well as healthy volunteers, undergo kidney ultrasound with SWE measurements combined with standard clinical, laboratory, and vascular assessments, with the aim of identifying the independent factors influencing kidney stiffness and evaluating its potential role as a simple, painless, and widely available imaging biomarker of kidney damage

Randomised Trial Comparing Thermal Ablation With Adrenalectomy in the Treatment of Unilateral Asymmetric PA

The primary objective of WAVE is to test the hypothesis that thermal ablation (microwave or RFA) is non-inferior to surgery in the biochemical (and if so, in the clinical) cure of unilateral PA, according to the international consensus PASO criteria. Secondary objectives are to determine whether either intervention is superior to the other in relation to the following outcomes. Where no superiority of either intervention is established, non-inferiority of thermal ablation against adrenalectomy will be sought. * Frequency and severity of adverse events * Length of inpatient stay * Patient satisfaction * Quality of life * Return to activities of daily living An additional secondary objective in the thermal ablation group alone will be anatomical efficacy of ablation.

[11C]Metomidate PET-CT vs Usual Care for People With Primary Aldosteronism: a Proof-of-concept Study

The goal of this randomised open-label controlled study is to compare the biochemical and clinical responses following \[11C\]Metomidate-PET CT(MTO-PET) versus usual care with adrenal venous sampling as first lateralisation strategy in people with biochemically confirmed primary aldosteronism(PA). The main question it aims to answer is: what is the proportion of people who achieved complete or partial clinical success among those who underwent PA treatment?

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

* 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)

Comparing Inclisiran Versus Statin for Primary Aldosteronism

Primary aldosteronism represents one of the leading causes of resistant hypertension. Circulating cholesterol is established as the exclusive substrate for adrenal aldosterone synthesis, and statins, which suppress cholesterol production, are currently widely applied in clinical settings. Emerging clinical evidence has demonstrated that in patients with essential hypertension, the plasma aldosterone level decreased by 43% (from 13.9 ng/dL to 7.9 ng/dL) after treatment with PCSK9 inhibitors. However, the effect of PCSK9 inhibitors with superior lipid-lowering efficacy combined with amlodipine besylate on aldosterone levels remains elusive. The present clinical trial adopted inclisiran, a PCSK9 inhibitor with well-documented clinical safety and robust lipid-lowering effects, in combination with amlodipine besylate. Through randomized grouping intervention and follow-up, this study aimed to compare the differential effects of two therapeutic regimens-inclisiran-based therapy and statin-based therapy-on plasma aldosterone levels, as well as improvements in a spectrum of clinical parameters including blood pressure , serum potassium and so on in patients with primary aldosteronism. The outcomes of this trial are expected to provide novel and more effective pharmacological strategies for the management of primary aldosteronism.

Cardiovascular Manifestations of MR Activation in Primary Aldosteronism: Pilot Clinical Study

This research study aims to learn more about the impact the hormone aldosterone on the heart. Primary aldosteronism is a condition where the body's adrenal glands make too much of the hormone aldosterone, which can cause high blood pressure and increase the risk of heart and kidney disease. Treatment with medications that block aldosterone can reduce that risk. This study is trying to learn whether treatment with a medication that blocks aldosterone can improve heart function in people who make too much aldosterone.

A Phase II Clinical Study on the Efficacy and Safety of HRS-1780 in Participants With Primary Aldosteronism

This study is a multicenter, randomized, double-blind, placebo-parallel-controlled phase II clinical trial to evaluate the efficacy and safety of HRS-1780 compared with placebo in participants with primary aldosteronism. The study plans to enroll 60 participants.

Left-atrial Fibrosis in Persistent Atrial Fibrillation and Its Comorbidities

Pulmonary vein isolation is an established intervention for atrial fibrillation. Patients with a paroxysmal atrial fibrillation have no or only few comorbidities and a good prognosis in respect to their atrial fibrillation. In contrast, patients with persistent atrial fibrillation often suffer from relevant comorbidities and recurrence of atrial fibrillation is common. Left-atrial fibrosis and its electrophysiological consequences are involved in the recurrence rate, but pathophysiological mechanisms are yet to be better characterized. The study investigates relevant comorbidities to elucidated their effect on atrial fibrosis and recurrence rates of atrial fibrillation. Furthermore, the investigators evaluate the prevalence of these comorbidities.

Finerenone for Patients With Primary Aldosteronism (FAIRY)

Using spironolactone as the control, to assess the efficacy and safety of finerenone in patients with primary aldosteronism(PA).

68Ga-Pentixafor PET/CT Versus Adrenal Vein Sampling in Primary Aldosteronism: The GAPA Randomized Clinical Trial

To compare the 68Ga-Pentixafor PET/CT and adrenal vein sampling on the long-term outcomes of primary aldosteronism (PA) patients with adrenal nodule (≥1cm)

Intensive vs. Standard Blood Pressure Control in Primary Aldosteronism

The goal of this clinical trial is to evaluate whether an intensive blood pressure control strategy (systolic blood pressure target \<120 mmHg) is more effective than a standard strategy (systolic blood pressure target \<140 mmHg) in reducing the risk of cardiovascular events in patients with primary aldosteronism. The main question it aims to answer is: Does the intensive blood pressure control strategy reduce the risk of composite cardiovascular events more than the standard strategy in patients with primary aldosteronism? The study employs a randomized design, allocating participants in a 1:1 ratio to either the Intensive Treatment Group or the Standard Treatment Group. Researchers will compare the differences in cardiovascular outcomes and safety profiles between the two groups over a planned follow-up period of 6 to 10 years. Participants will: Undergo randomization and adhere to the assigned blood pressure management protocol. Attend regular follow-up visits for blood pressure measurement, laboratory tests, questionnaires, etc. Report any adverse events or changes in health status.

Diagnosing Variable Primary Aldosteronism.

The goal of this observational study is to see if there is a cyclical or exaggerated diurnal variation in aldosterone production in people with Primary Aldosteronism.

Baxdrostat and Molecular Imaging of Adrenal Cytoreduction in Primary Aldosteronism

The goal of this clinical trial is to find out whether treatment with baxdrostat changes aldosterone-producing activity in the adrenal glands of people with primary aldosteronism. The study will use specialised imaging to measure changes in the adrenal glands before and after treatment. Participants will receive baxdrostat for 24 weeks and will be followed for changes in their adrenal imaging, blood pressure and hormone levels. The study will also investigate whether changes caused by treatment continue after baxdrostat is stopped. This is a single-group study, meaning that all participants receive baxdrostat and there is no placebo or comparison group.

Regular Sauna Use to Lower Blood Pressure in Primary Aldosteronism

1. Background and Rationale: Primary aldosteronism is a hypertension-related disorder where salt restriction/salt loss is a central part of therapy. Dietary salt restriction to sufficient degree is very difficult for most patients and thus medications are frequently required to control blood pressure. Non-pharmacologic means of reducing total body sodium and blood pressure are required and desired by patients. Sauna bathing is a traditional wellness practice associated with extensive sweating and therefore salt loss. We wish to study whether incorporation of sauna bathing into a treatment plan for primary aldosteronism might lower blood pressure without increased medications. A pilot feasibility study is required prior to design of a larger controlled clinical trial. We are looking to conduct a short term simulated sauna study to assess patient acceptability and study feasibility as the primary outcomes. 2. Research Questions and Objectives: This study will test the feasibility of having patients add regular sauna usage to their weekly lifestyle, while being treated for hypertension due to primary aldosteronism. The primary objective will be to assess patient recruitment rates, subject retention, patient acceptability, and patient adherence to regular sauna intervention during a 2-week period, using an a priori "traffic light" decision matrix. The secondary objectives will be to explore change in blood pressure, as measured by a wearable, continuous BP wrist monitor, before and after a 2 week sauna intervention. 3. Methods: The study will occur in the context of routine ongoing care in the Endocrine Hypertension Clinic. Ten patients with primary aldosteronism will be recruited to a 7 week study where we will observe the feasibility and acceptability of wearing a continuous, cuffless, wrist BP monitoring device for 2-week periods prior to, during, and after a 2 week "sauna" therapy program. The sauna therapy will consist of three 30 minute visits to a commercially licensed and insured local sauna club each week for 2 weeks. Standardized subject experience questionnaires will collect feasibility and acceptability data which will be analyzed with a standard red light/yellow light/green light approach to study feasibility conclusions.

EndoSense: Continuous Real-Time Monitoring of Health Markers in Endocrine and Metabolic Disorders

The goal of this trial is to learn whether wearable devices and hormone sampling can measure how the body changes during daily-life challenges in adults with endocrine or metabolic disorders. These disorders include conditions such as high blood pressure, adrenal disorders, diabetes, obesity, thyroid disorders, pituitary disorders, and other hormone-related conditions. The main questions it aims to answer are: Can wearable devices measure changes in blood pressure, heart rate, sleep, activity, temperature, and glucose during changes in salt intake, meals, fasting, and short exercise? Do these changes differ between people with different endocrine or metabolic disorders? Are wearable devices acceptable and practical for participants to use at home? There is no comparison group in this study. Each participant will serve as their own comparison by completing different study phases. Participants will wear study devices at home to measure blood pressure, heart rate, activity, sleep, temperature, and glucose, follow a low-salt diet for about 1 week and then a high-salt diet for about 1 week, using study instructions, complete meal, fasting, and short exercise tasks, give urine and saliva samples, and possibly blood samples, during the study. Optionally wear a hormone sampling device for about 27 hours, complete short questionnaires about symptoms, sleep, physical activity, and their experience using the devices. The study will help researchers understand whether wearable monitoring can support future diagnosis and care for people with endocrine and metabolic disorders.

Endoscopic Ultrasound-Guided Ethanol Ablation for Aldosterone-Producing Adenoma

This is a prospective, single-center, single-arm study evaluating endoscopic ultrasound-guided ethanol ablation for left-sided aldosterone-producing adenoma. Eligible participants will receive the ablation procedure and be followed for safety, imaging response, biochemical remission, and clinical remission. The study is expected to enroll 30 participants.

A Novel and Efficient Biochemical Screening Strategy for Glucocorticoid-Remediable Aldosteronism: Combined 1-mg Overnight Dexamethasone Suppression Test and Steroid Profile

This prospective observational study evaluates a simplified biochemical screening strategy to differentiate Glucocorticoid-Remediable Aldosteronism (GRA) from Aldosterone-Producing Adenoma (APA). The approach combines a 1-mg overnight dexamethasone suppression test (ODST) with LC-MS/MS steroid profiling. We aim to establish diagnostic cut-off points for aldosterone and hybrid steroid (18-oxoF, 18-OHF) suppression rates as an efficient screening tool prior to genetic testing.

Study on the Application of Liquid Chromatography-Tandem Mass Spectrometry for the Determination of Aldosterone and Renin Activity in the Diagnosis of Primary Aldosteronism by Captopril Test

Primary aldosteronism (PA) is the most common cause of secondary hypertension. Liquid chromatography-tandem mass spectrometry (LC-MS/MS) is more accurate than the traditional radioimmunoassay method in measuring aldosterone. This study aims to establish a more precise diagnostic cutoff value for the captopril stimulation test (CCT) by measuring aldosterone levels using LC-MS/MS. The investigators will combine the detection results of CCT from healthy volunteers and suspected PA patients, etc., to determine the new CCT cutoff value. The investigators expect to improve the diagnostic accuracy of PA, helping clinicians identify this curable cause of hypertension earlier and more accurately, and achieving precise treatment.

Efficacy and Safety of Finerenone Compared to Spironolactone in Treatment of Primary Aldosteronism

The goal of this study is to compare the efficacy and safety of finerenone versus spironolactone in the treatment of hypertension due to primary aldosteronism. It will be a randomized, double-blind, active-controlled, parallel-group clinical trial conducted at the Endocrine Hypertension Clinic, Department of Endocrinology, BSMMU. A total of 104 adult patients with confirmed primary aldosteronism will be enrolled and randomized equally to receive either finerenone (10-40 mg/day) or spironolactone (25-100mg/day) for 48 weeks. Study drugs will be titrated to achieve target blood pressure (\<140/90mmHg) and unsuppressed plasma renin concentration (\>15 mU/L). The primary efficacy outcome will be the time and daily dose required to attain this composite endpoint. Secondary outcomes include changes in clinic and ambulatory blood pressure, plasma aldosterone and renin levels, renal function (eGFR), urinary albumin excretion, left ventricular mass index, and quality of life. Safety outcomes will include adverse events, particularly hyperkalaemia and deterioration of renal function.

A Phase II Clinical Trial of Efficacy and Safety of SAL0140 at Different Doses in Patients With Primary Aldosteronism

This is a multicenter, randomized, double-blind, placebo-controlled phase II study designed to explore the efficacy and safety of different doses of SAL0140 in primary aldosteronism.

Study on the Diagnostic Cut-off Point of 24-hour Urinary Aldosterone Measured by Liquid Chromatography-Tandem Mass Spectrometry in the Diagnosis of Primary Aldosteronism in the Oral Sodium Loading Test

Primary aldosteronism (PA) is the most common cause of secondary hypertension. Liquid chromatography - tandem mass spectrometry (LC-MS/MS) is more accurate than the traditional radioimmunoassay in measuring aldosterone. This study aims to establish a more precise diagnostic threshold for the oral sodium loading test (OSLT) by using LC-MS/MS to measure urinary aldosterone levels. We will combine the biochemical results of OSLT and other data from healthy volunteers and suspected PA patients to determine a new 24-hour urinary aldosterone threshold. We expect to improve the diagnostic accuracy of PA, helping clinicians identify this curable cause of hypertension earlier and more accurately, and achieving precise treatment.

Study on Cutoff Revision Effects and Evaluation of NNT in Primary Aldosteronism

The goal of this observational study is to evaluate the real-world impact of applying the revised aldosterone-to-renin ratio (ARR) cutoff recommended in the 2025 primary aldosteronism guideline in adults with hypertension and biochemical findings suggestive of an intermediate probability of lateralizing primary aldosteronism (PA). The main questions it aims to answer are: * What is the number needed to test (NNT) to diagnose one case of primary aldosteronism when using the revised ARR cutoff (\>20)? * What is the optimal ARR cutoff for diagnosing PA in Korean patients? * What is the biochemical treatment response rate at 6 months after treatment for confirmed PA? Participants will: * Undergo standardized ARR testing after protocol-based medication adjustment and controlled sampling conditions. * Undergo confirmatory testing using the saline infusion test (SIT). * Receive standard clinical management for confirmed PA according to institutional practice. * Be followed for assessment of biochemical outcomes after treatment.

Endoscopic Ultrasound-guided Radiofrequency Ablation in Primary Aldosteronism

In this study, the investigators will perform endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) treatment of left-sided adrenal tumours in patients with primary aldosteronism (PA) and in patients with mild autonomous cortisol secretion (MACS). Four different study groups will all receive EUS-RFA of left-sided adrenal tumours. Clinical and biochemical outcome as well as procedural safety will be evaluated. In study patients with verified lateralised aldosterone or cortisol overproduction to the left adrenal, outcome will be compared with control groups performing conventional unilateral adrenalectomy. Study group 1: PA patients with AVS-verified left sided lateralisation and a EUS-detectable tumour in the left adrenal for EUS-RFA treatment. Study group 2: PA patient with suspected left-sided overweight of aldosterone production and a EUS-detectable tumour but without strict lateralisation of their aldosterone overproduction, for EUS-RFA treatment as an aldosterone "debulking" procedure. Study group 3: patients with MACS with AVS-verified lateralisation of cortisol overproduction to the left adrenal and EUS-detectable tumour for EUS-RFA treatment Study group 4: patients with MACS with bilateral adrenal tumours and verified bilateral overproduction of cortisol for EUS-RFA treatment as a cortisol "debulking" procedure.