NCT07800858Not yet recruiting
Baxdrostat and Molecular Imaging of Adrenal Cytoreduction in Primary Aldosteronism
Effects of aLdosterone Inhibition by baXdrostat on Molecular Imaging of cytoReduction in Primary Aldosteronism and Hypertension
Source: ClinicalTrials.gov · Last updated 2 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 20 Aug 2026
- Start date
- 15 Sept 2026
- Primary completion date
- 31 May 2028
- Lead sponsor
- Queen Mary University of London
- Diseases
- High blood pressure
- NCT number
- NCT07800858
What you commit to
- Study type: Interventional
- Planned participants: 30
- From 15 Sept 2026 to the primary completion date, 31 May 2028
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- Male or female
- Age \> 18 years at time of signing informed consent.
- Diagnosed with Primary Aldosteronism (PA) according to Endocrine Society guidelines
- Presence of one or more adrenal nodules, (diameter 0.5-2.5 cm) on CT, PET-CT, or MRI, with characteristics (e.g. washout) of adenomas
- Suppressed cortisol after overnight dexamethasone
- Willing to take baxdrostat for 6 months and attend follow-up visits
- Willing to undergo PET-CT imaging
- Estimated glomerular filtration rate ≥ 45 mL/min/1.73m2 at Screening.
- Serum potassium (K+) level ≥ 3.5 and \< 5.0 mmol/L
- Negative pregnancy test for female participants of childbearing potential
- Able and willing to provide written consent Exclusion criteria
- \<18 years of age
- Current or prior treatment (within 1 month before screening) with angiotensin-receptor blockers in combination with ACEIs.
- Serum sodium level \< 135 mmol/L at screening, determined as per central laboratory.
- The following known secondary causes of hypertension: renal artery stenosis, uncontrolled or untreated hyperthyroidism, uncontrolled or untreated hypothyroidism, pheochromocytoma, Cushing's syndrome, aortic coarctation.
- New York Heart Association functional Heart Failure class IV at Screening.
- Known current severe left ventricular outflow obstruction, such as obstructive hypertrophic cardiomyopathy and/or severe aortic valvular disease.
- Known severe hepatic impairment.
- Uncontrolled diabetes with HbA1c \> 10.0% (86 mmol/mol) at screening.
- Participants suspected to have severe cardiac hypertrophy.
- Treatment with any MRAs or potassium-sparing diuretics within 1 month prior to screening.
- Treatment with potassium binders within 1 month prior to screening.
- Is expected to receive or is receiving any of the exclusionary drugs such as strong inducers of cytochrome P450 (CYP) 3A, chronic (taken more than 3 times a week for more than 3 months) use of NSAIDs, MRAs or chronic use of systemic steroids.
- Treatment with K+ supplements is not prohibited but the use should be continuously assessed throughout the trial.
- Inability or unwillingness to undergo PET-CT imaging
- Significant comorbidities that would interfere with participation
- Pregnancy or breastfeeding
- Unable to give informed consent
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cambridge NHS Foundation Trust Coordinator of this site? Confirm its status | Cambridge | United Kingdom | Unknown status |
| Barts NHS Trust Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.