Ongoing Clinical Trials for Primary Hyperaldosteronism
There are currently 3 ongoing clinical trials investigating new approaches to diagnose and treat primary hyperaldosteronism, a hormonal disorder that causes high blood pressure. These trials are taking place in France, Germany, Italy, the Netherlands, and Spain, testing both advanced imaging techniques and new medications to better manage this condition.
Clinical trial locations
- France
- Germany
- Italy
- Netherlands
- Spain
Study Comparing [68Ga]Ga-PentixaFor PET/CT and AVS for Diagnosing Primary Aldosteronism in Patients with Hypertension
This trial, conducted in the Netherlands, is comparing two different diagnostic methods for identifying the source of excess aldosterone production in patients with confirmed primary aldosteronism. The study evaluates whether a special imaging technique called PET/CT scan using [68Ga]Ga-PentixaFor can provide similar or better results compared to a traditional procedure called adrenal venous sampling.
Who can participate: Adults over 18 years old with a confirmed diagnosis of primary aldosteronism are eligible. The diagnosis must be confirmed by a high aldosterone-to-renin ratio and an intravenous salt-loading test following specific medical guidelines. Participants must provide informed consent after understanding all details of the study.
Who cannot participate: The trial excludes patients who do not have primary aldosteronism, those outside the specified age range, and individuals who belong to vulnerable populations requiring special protection or care.
What the trial involves: Participants are randomly assigned to either undergo the new PET/CT imaging technique or the traditional adrenal venous sampling procedure. The PET/CT scan uses an injected solution containing [68Ga]Ga-PentixaFor, which helps highlight specific areas during the scan to identify aldosterone-producing tumors in the adrenal glands. Researchers will monitor participants for six months to compare how well each method identifies the condition and affects blood pressure control. Some participants may receive a second PET/CT scan within 1-14 days to evaluate the reproducibility of results. The study also assesses quality of life, safety, and cost-effectiveness of both diagnostic approaches.
Investigational approaches: The study tests [68Ga]Ga-PentixaFor as an imaging agent that targets the CXCR4 receptor, often overexpressed in certain tissues. This radiopharmaceutical is administered intravenously and helps visualize aldosterone-producing adenomas during PET/CT scanning. The trial will compare its diagnostic accuracy to adrenal venous sampling, which directly measures hormone levels from the adrenal gland veins.
Study of baxdrostat compared to placebo to treat adults with primary aldosteronism
This international trial is testing a new medication called baxdrostat in adults with primary aldosteronism. The study takes place across multiple European countries including Germany, Italy, France, and Spain, and aims to evaluate whether baxdrostat can effectively lower blood pressure in people with this hormonal condition.
Who can participate: Adults aged 18 years or older with confirmed primary aldosteronism according to specific medical guidelines are eligible. Participants must have kidney function test results of 45 mL/min/1.73m² or higher, blood potassium levels between 3.0 and 5.0 mmol/L, and seated systolic blood pressure of 135 mmHg or higher. They must be willing to stop taking certain medications called mineralocorticoid receptor antagonists or potassium-sparing diuretics and must have been on stable doses of other blood pressure medications for at least 4 weeks before joining the study.
Who cannot participate: The trial excludes people over 75 years old, those with a history of heart attacks, uncontrolled diabetes, severe kidney or liver disease, pregnant or breastfeeding women, and individuals currently participating in other clinical trials. People with a history of substance abuse within the past year, known allergies to the study medication, major surgery within the last 3 months, cancer within the past 5 years (except successfully treated skin cancer), psychiatric conditions interfering with participation, or life expectancy less than 12 months are also excluded.
What the trial involves: The treatment period lasts approximately one year. Before starting the medication, participants may need to stop taking certain blood pressure medications and must maintain stable doses of other blood pressure treatments. Participants will receive either baxdrostat tablets or placebo tablets daily, taken by mouth at doses ranging from 2 to 4 milligrams per day. Throughout the 52-week study period, blood pressure will be monitored regularly, and blood tests will check potassium levels, hormone levels in blood and urine, and kidney function.
Investigational medication: Baxdrostat is an oral medication that works by selectively inhibiting aldosterone synthase, the enzyme responsible for producing aldosterone. By blocking this enzyme, the medication helps regulate blood pressure and electrolyte balance in patients with primary aldosteronism. This represents a novel approach to treating this specific form of secondary hypertension.
Study on [68Ga]Ga-PentixaFor PET Imaging for Identifying Unilateral Adrenal Aldosterone Secretion in Patients with Primary Aldosteronism
This French clinical trial uses advanced PET imaging technology to determine whether excess aldosterone production comes from one or both adrenal glands in patients with primary aldosteronism. This information is crucial for planning appropriate treatment options.
Who can participate: Adults aged 18 years or older with a confirmed diagnosis of primary aldosteronism are eligible. This includes patients with or without visible adrenal nodules on CT or MRI scans, and those with either one-sided or both-sided aldosterone secretion confirmed by adrenal vein sampling. Participants must be affiliated with French Social Security, have signed informed consent, and women of childbearing age must use effective contraception during the study.
Who cannot participate: While the trial data does not specify detailed exclusion criteria, standard exclusions for imaging studies and radiopharmaceutical use would typically apply.
What the trial involves: After an initial assessment to confirm eligibility, participants receive an intravenous injection of [68Ga]Ga-PentixaFor solution. A PET scan is then performed to evaluate the activity of both adrenal glands by measuring standardized uptake values. The imaging results help identify which adrenal gland is producing excess aldosterone. Researchers analyze the differences in uptake between the two glands to understand the lateralization of aldosterone secretion. Follow-up assessments may include blood tests and additional imaging to monitor aldosterone levels and adrenal function, while also evaluating the safety and tolerance of the injections.
Investigational imaging agent: [68Ga]Ga-PentixaFor is a radiopharmaceutical that binds to specific receptors in the adrenal glands, allowing clear visualization during PET scanning. This diagnostic tool helps determine if aldosterone secretion originates from one side or both sides of the adrenal glands, which is essential information for guiding treatment decisions.
Summary
The three ongoing clinical trials for primary hyperaldosteronism reflect a two-pronged research approach: improving diagnostic accuracy and developing new treatments. Two of the three trials focus on advanced imaging techniques using [68Ga]Ga-PentixaFor PET scanning, highlighting the medical community’s interest in finding less invasive and more accurate methods to identify the source of excess aldosterone production. These imaging studies are being conducted in the Netherlands and France.
The treatment-focused trial testing baxdrostat represents a novel pharmacological approach by directly targeting the enzyme responsible for aldosterone production. This international study spans four European countries, making it the most geographically diverse trial and potentially offering access to a larger patient population. The baxdrostat trial also has the longest duration at 52 weeks, providing extensive data on long-term safety and effectiveness.
All three trials require confirmed diagnosis of primary aldosteronism and include careful monitoring of blood pressure, potassium levels, and kidney function throughout the study periods. These trials aim to provide valuable insights that could improve both the diagnosis and management of this condition, which is characterized by excessive aldosterone production leading to high blood pressure and electrolyte imbalances.
