Finerenone for Patients With Primary Aldosteronism (FAIRY)
ConditionPrimary Aldosteronism
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-75
SponsorQifu Li
About this trial
Using spironolactone as the control, to assess the efficacy and safety of finerenone in patients with primary aldosteronism(PA).
Eligibility criteria
Qualifiers
. Aged between 18-75, male or female;
. With confirmed PA diagnosis (screening positive and at least one confirmatory test is positive); NOTE: Screening positive was defined as plasma aldosterone-to-renin ratio (ARR)
. Not taking any antihypertensive drugs or on a stable regimen of antihypertensive agents(Limited to alpha-adrenergic receptor blockers and calcium channel blockers.) for more than four weeks before screening;
. With a mean seated office SBP≥140 or DBP≥90 mmHg;
Disqualifiers
Has a plan to conduct PA subtype classification(eg. Adrenal vein sampling, PET-CT) in 3 months；
Has planned surgery within 3 months;
With a mean seated office SBP ≥ 180mmHg or DBP ≥ 110mmHg before randomization; Note: Mean seated BP is defined as the average of 3 seated BP measurements at any single clinical site visit. If the patient did not take their regularly scheduled antihypertensive medications prior to the visit, 1 BP re-test is allowed within 2 days after taking the medications.
Night shift workers;
Trial design
Treatments tested in this trial
- Finerenone Oral Tablet
- Spironolactone Oral Tablet
Treatment groups
306 Participants
are divided into 2 treatment groupsSponsors and collaborators
Qifu Li
Lead sponsor
Chongqing Medical University
Sponsor institution
The Affiliated Hospital Of Southwest Medical University
Collaborator
The First Affiliated Hospital of Zhengzhou University
Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborator
Changzhi Medical College
Collaborator
Source ClinicalTrials.gov