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Unilateral Primary Aldosteronism, Mineralocorticoid Antagonists Versus Surgical Treatment

NCT05797558 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-04-06

No results posted yet for this study

Summary

This is a prospective randomized controlled trial where quality of life and the effectiveness of treatment will be evaluated in 80 patients with confirmed unilateral primary aldosteronism ,randomly assigned to be either treated surgically with unilateral adrenalectomy or to receive medical treatment with eplerenone.

Conditions

  • Primary Hyperaldosteronism Due to Adrenal Adenoma

Interventions

PROCEDURE

Unilateral adrenalectomy

Minimally invasive surgery is performed via the lateral transperitoneal approach or the posterior retroperitoneal approach, with or without robotic assistance, according to the surgeon's preference.

DRUG

Medical treatment (eplerenone)

The initial dose of eplerenone is 25 mg twice daily. The dose will be increased by 50 mg every fourth week until systolic blood pressure of 140 mmHg and diastolic blood pressure of 90 mmHg or lower has been reached and biochemical control (plasma renin above the middle of the reference range, i.e \> \~20 mIU/L) is attained and/or hyperkalemia develops. The maximal dose of eplerenone is 300 mg twice daily.

Sponsors & Collaborators

  • Karolinska Institutet

    collaborator OTHER

  • Umeå University

    collaborator OTHER

  • Göteborg University

    lead OTHER

Principal Investigators

  • Oskar Ragnarsson, MD · Institute of Medicine, Sahlgrenska Academy, University of Gothenburg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-28
Primary Completion
2028-05-28
Completion
2028-05-28

Countries

  • Sweden

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05797558 on ClinicalTrials.gov