NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

Baxdrostat and Molecular Imaging of Adrenal Cytoreduction in Primary Aldosteronism

Not Yet RecruitingNA

Sponsor: Queen Mary University of London

Conditions: Primary Aldosteronism

Interventions: baxdrostat

Countries: United Kingdom

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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
* \<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

Locations (2)

Cambridge, United Kingdom
London, United Kingdom