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Completed

NCT Number: NCT05924620

Efficacy and Safety of Finerenone in Patients With Primary Aldosteronism

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

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The First Affilated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400016, China

About this study

This is a prospective and randomized study involving patients with primary aldosteronism(PA). All paticipants will be randomized into finerenone group(Intervention group) and spironolactone group(Control group) and to compare the antihypertensive effect in patients with PA.

If the self-measured blood pressure of patients at home continues to be greater than 140/90 mmHg at 2-4 weeks, spironolactone or finerenone should be increased to 40mg qd, and electrolytes should be reviewed at 2 weeks after dosed.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients who meet the following criterion can be included in this study.

  • 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

Exclusion criteria

Patients with one of the following conditions will be excluded in this study:

  • 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

Treatment and study plan

Finerenone

Drug

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

Other names: Kerendia

Primary outcomes

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

    Time frame: At baseline and 2 month of follow-up

    Measured by ambulatory blood pressure monitoring

Secondary outcomes

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

    Time frame: At baseline and 2 month of follow-up

    Measured by blood electrolytes

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

    Time frame: At baseline and 2 month of follow-up

    Measured by ambulatory blood pressure monitoring

Sponsors and collaborators

Lead sponsor

Chongqing Medical University

Other

Registry information

Official study title

Efficacy and Safety of Finerenone in Patients With Primary Aldosteronism: a Randomized, Controlled Trial

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 29, 2023
Registry last updated
Jun 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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