← Back to all trials
Not Yet Recruiting
NCT07800858
Baxdrostat and Molecular Imaging of Adrenal Cytoreduction in Primary Aldosteronism
Conditions: Primary Aldosteronism
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 30
Sponsor: Queen Mary University of London
Location: Cambridge NHS Foundation Trust Cambridge
Summary
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.
Eligibility Criteria
Inclusion criteria
* 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
* \
Source: ClinicalTrials.gov (NCT07800858). StuddyBuddy aggregates publicly available trial information.