Efficacy and Safety of Finerenone in Patients With Primary Aldosteronism

NCT05924620 | Completed Phase 4 FDA Drug

• 1 other identifier: Finerenone study
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

To study the efficacy and safety of finerenone in patients with primary aldosteronism

Conditions

Primary Aldosteronism

Keywords

finerenone; spironolactone

Outcome Measures

Primary Outcomes (1)

• Compare the change of daytime mean systolic blood pressure in the overall cohort between two groups.

  Measured by ambulatory blood pressure monitoring

  At baseline and 2 month of follow-up

Secondary Outcomes (2)

• Compare the serum potassium elevation in the overall cohort between two groups.

  At baseline and 2 month of follow-up

• Compare the change of daytime mean diastolic blood pressure in the overall cohort between two groups.

  At baseline and 2 month of follow-up

Study Arms (2)

Patients with PA using finerenone

EXPERIMENTAL

Patients with PA divided into this group need to take finerenone for 60 days (20mg qd)

Drug: finerenone

Patients with PA using spironolactone

NO INTERVENTION

Patients with PA divided into this group need to take spironolactone for 60 days (20mg qd)

Interventions

finerenone DRUG

Patients with PA divided into Intervention group need to take finerenone for 60 days (20mg qd).

Also known as: Kerendia

Patients with PA using finerenone

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients know the whole process of the trial and voluntarily accepted randomization, intervention and follow-up.
• Patients voluntarily participated in the study and signed an informed consent, willing to complete all follow-up visits as required.
• Aged between 18-70, male or female, with legal capacity.
• eGFR≥60(ml/min/1.73 m2)
• Patients with PA and substandard blood pressure (≥140/90mmHg) who didn't take any antihypertensive drugs or who had been using antihypertensive drugs other than MRA steadily for 2 weeks or more

You may not qualify if:

• To assess patients with poor compliance who had difficulty fully participating in the study, or who refused to sign written informed consent for the study
• Patients with heart failure (New York Heart Association (NYHA) class III or IV), liver transaminase levels were more than 2 times higher than the upper limit of normal, estimated glomerulus filtration rate\<30ml/min/m2
• Patients with serum potassium \> 5.0mmol/L without potassium supplementation
• Patients with stroke or acute coronary syndrome within 3 months
• Pregnant or lactating women
• Patients currently receiving sex hormone or glucocorticoid therapy
• Patients with a history of uncontrolled malignant tumor
• Patients who took MRA within 2 weeks

Sponsors & Collaborators

• Chongqing Medical University: lead

Study Sites (1)

The First Affilated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400016, China

Location

MeSH Terms

Conditions

Hyperaldosteronism

Interventions

finerenone

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases

Study Officials

• Qifu Q Li, PhD

  the Chongqing Primary Aldosteronism Study (CONPASS) Group

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor.Qifu Li

Study Record Dates

• First Submitted: June 21, 2023
• First Posted: June 29, 2023
• Study Start: June 21, 2023
• Primary Completion: March 12, 2024
• Study Completion: March 12, 2024
• Last Updated: June 18, 2024

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)