Clinical Research Directory

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.

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)

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).

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.

[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?

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.

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.

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.

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.

Radiofrequency Ablation for Aldosterone-producting Adenoma in Patients With Primary Aldosteronism

The aim of the study is to evaluate the novel use of adrenal radiofrequency ablation on a prospective cohort of patients with primary aldosteronism and unilateral adrenal adenoma concerning the efficacy on blood pressure control. The safety of the procedure is one of the secondary outcomes.

Study on the Incidence of Adrenal Insufficiency After Surgery in Primary Aldosteronism Patients Concurrent With or Without Autonomous Cortisol Secretion

To evaluate the incidence of adrenal insufficiency after surgery in Primary aldosteronism (PA) patients concurrent with or without autonomous cortisol secretion (ACS). To assess the recovery time of postoperative adrenal insufficiency in patients. And to explore the clinical characteristics and predictive indicators of patients requiring postoperative hormone replacement therapy.

Steroids-Based Screening for Primary Aldosteronism

This prospective, single-center observational study aims to evaluate whether a steroid-based screening method can more accurately identify Primary Aldosteronism (PA) in hypertensive patients who remain on their usual antihypertensive medications, compared with the conventional aldosterone-to-renin ratio (ARR). PA is a common, potentially curable subtype of secondary hypertension that carries increased cardiovascular risk when undiagnosed or untreated. However, current screening protocols recommend "medication washout" or switching to minimally interfering drugs, which may pose safety concerns and add complexity. In this study, approximately 406 participants (ages 18-75) with diagnosed hypertension and on at least one interfering antihypertensive drug (such as ACE inhibitors, ARBs, beta-blockers, diuretics, or calcium channel blockers) will be enrolled at the Department of Endocrinology, The First Affiliated Hospital of Chongqing Medical University. Each participant will undergo two rounds of blood sampling-first while continuing their usual antihypertensive regimen (the "on-medication" state) and second following a standardized washout/switch period (the "standard state"), if medically feasible. At both stages, levels of plasma aldosterone, renin, and a broad panel of adrenal steroid hormones will be measured by liquid chromatography-tandem mass spectrometry. By comparing diagnostic performance (e.g., sensitivity, specificity, and area under the receiver operating characteristic curve) of the steroid-based screening versus the ARR, the study seeks to determine whether steroid profiling improves accuracy under real-world treatment conditions. Findings may help refine PA screening strategies, reduce the need for extensive medication adjustments, and contribute to better clinical management of hypertension.

REnin-guided TherApy With MinEralocorticoid Receptor Antagonists in Primary Aldosteronism - Feasibility Study

High blood pressure, or hypertension, can be caused by a condition called Primary Aldosteronism (PA), where the body produces too much of a hormone called aldosterone. People with PA have a higher risk of heart problems compared to those with regular high blood pressure. To treat PA, some patients need to take medicine called mineralocorticoid receptor antagonists (MRA) for the rest of their lives. While treatment with MRA is effective, it can have side effects like high levels of potassium in the blood, breast enlargement in men, menstrual problems in women, and reduced sex drive. Finding the right dose of MRA for each patient can be tricky. Recent observations suggest that when a hormone called renin goes up during MRA treatment, it might be a good sign. This is because renin is higher when the action of aldosterone is well blocked. But it's not certain if this happens because of the patient's unique characteristics or if it can truly be a way to know if the treatment is working. This study aims to find out if guiding MRA treatment with renin levels leads to more patients having unsuppressed renin levels compared to the standard of care. This is a multicentric pragmatic clinical trial. Patients with a new diagnosis of PA and low renin levels will be asked if there are willing to participate. Those with recent use of MRA, known MRA intolerance, severe kidney problems, or have high potassium levels will not be able to participate. Participants will be randomized into two groups: one group will have their MRA treatment adjusted based on renin levels (the "renin-guided" group), and the other group won't have renin levels checked during treatment (the "renin-blinded" group). Both groups will aim to have their blood pressure under control and potassium levels in the normal range. The main outcome is the proportion in each group with unsuppressed renin levels after 12 months. Other outcomes will be tested, such as changes in renin levels, how well the treatment works, and any safety concerns (like potassium levels, kidney function, side effects, and blood pressure changes). Different groups of patients will also be looked at separately, like men and women, different ages, races, and initial renin levels, to see if the approach works better for some people. This study will help find a safe and effective way to treat PA with MRA. Choosing the right dose of MRA is important to adequately block aldosterone but also to avoid side effects.

68Ga-Pentixafor PET/CT Versus Adrenal Vein Sampling in Diagnosing Unilateral Subtype of Primary Aldosteronism Concurrent With Autonomous Cortisol Secretion (PREDICT)

To validate the accuracy of 68Ga-Pentixafor PET/CT and adrenal venous sampling (AVS) in subtype diagnosis of PA/ACS patients with adrenal nodules, based on biochemical and clinical remission outcomes, and to determine whether the diagnostic accuracy of 68Ga-Pentixafor PET/CT is non-inferior to AVS.

Prognosis of Primary Aldosteronism: A Prospective Cohort Study

Primary aldosteronism (PA) is the most common cause of secondary hypertension, and patients with PA have a significantly higher risk of developing cardiovascular and renal complications compared with those with essential hypertension. However, PA remains substantially underdiagnosed and undertreated in clinical practice, and relevant research data on the short-term and long-term prognosis of PA patients in the Chinese population are particularly scarce. This is a multicenter, prospective cohort study designed to systematically collect real-world clinical data of PA patients, including baseline clinical characteristics, etiological subtypes, diagnostic and therapeutic strategies, and long-term follow-up outcomes. Through 5 years of standardized follow-up, this study will analyze the differences in treatment efficacy among PA patients with different pathological subtypes (e.g., adrenal adenoma, adrenal hyperplasia), evaluate the short-term therapeutic efficacy and long-term prognosis of PA patients undergoing different treatment modalities including pharmacotherapy, surgery and interventional therapy, and explore the risk factors for adverse clinical outcomes. Ultimately, it will provide high-quality real-world evidence-based data to optimize the clinical diagnosis and management of PA and improve the long-term prognosis of affected patients.

Genetic Predisposition to High Blood Pressure

Primary aldosteronism (PA) is a known but underdiagnosed cause of high blood pressure. It is estimated that more than 10% of all people with high blood pressure (HT) suffer from PA, which is often caused by aldosterone-producing adrenal cortical tumors (APAs). In a pilot study with 35 patients with APAs leading to hypertension, the investigators have identified a genetic variant in a presumed Calcium-channel gene. The variant was significantly overrepresented in patients with APAs compared to the normal population (12% compared to approximately 4%). Interestingly, all patients having APAs and the variant were men. The SCAPIS study is a world-unique Swedish research study in the field of heart/lungs, in which 30,000 randomly selected people between the ages of 50-64 participated. The study is a collaboration between the universities of Gothenburg, Lund, Linköping, Uppsala and Umeå, as well as the Karolinska Institute in Stockholm. In Linköping, about 5,000 persons participated. The investigators have now screened 4762 persons from the SCAPIS study for this variant and found it in little less than 6%. Overall, patients with the variant had more often been diagnosed with HT and were mote often treated for HT as well. Interestingly, this difference was only found in men. The investigators now want to investigate the following: 1. identify those persons with the genetic variant and HT that have PA, 2. identify those persons with PA that have APAs/unilateral disease, 3. identify how many patients with APAs/unilateral disease can be cured by surgery.

The Association Between Primary Aldosteronism and Cognitive Dysfunction

The goal of this observational study is to learn about the prevalence, progression, and influencing factors of cognitive impairment in patients with primary aldosteronism (PA). The main questions it aims to answer are: 1. What is the prevalence of baseline cognitive impairment in PA patients and what factors are associated with it? 2. What is the incidence of cognitive progression in PA patients within 1 and 5 years of follow-up and what factors influence this progression? Participants who are already diagnosed with PA as part of their regular medical care will be invited to join this long-term study. They will complete regular cognitive tests, medical check-ups, and questionnaires for up to 5 years. Some participants will also have optional blood tests and brain scans to help researchers understand the causes behind any cognitive changes.