Genetic Predisposition to High Blood Pressure

NCT ID: NCT07181213

Last Updated: 2025-09-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2027-12-31

Brief Summary

Primary aldosteronism (PA) is a known but underdiagnosed cause of high blood pressure. It is estimated that more than 10% of all people with high blood pressure (HT) suffer from PA, which is often caused by aldosterone-producing adrenal cortical tumors (APAs).

In a pilot study with 35 patients with APAs leading to hypertension, we have identified a genetic variant in a presumed Calcium-channel gene. The variant was significantly overrepresented in patients with APAs compared to the normal population (12% compared to approximately 4%). Interestingly, all patients having APAs and the variant were men.

The SCAPIS study is a world-unique Swedish research study in the field of heart/lungs, in which 30,000 randomly selected people between the ages of 50-64 participated. The study is a collaboration between the universities of Gothenburg, Lund, Linköping, Uppsala and Umeå, as well as the Karolinska Institute in Stockholm. In Linköping, about 5,000 persons participated.

We have now screened 4762 persons from the SCAPIS study for this variant and found it in little less than 6%. Overall, patients with the variant had more often been diagnosed with HT and were mote often treated for HT as well. Interestingly, this difference was only found in men.

We now want to investigate the following:

1. identify those persons with the genetic variant and HT that have PA,

2. identify those persons with PA that have APAs/unilateral disease,

3. identify how many patients with APAs/unilateral disease can be cured by surgery.

Conditions

Hypertension; Primary Aldosteronism; Genetic Predisposition to Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Presence of unilateral primary aldosteronism in patients with genetic variant and hypertension

Group Type: ACTIVE_COMPARATOR

Adrenalectomy

Intervention Type: PROCEDURE

Surgical removal of patients with unilateral primary aldosteronism in patients selected by the presence of a genetic variant and hypertension

Interventions

Adrenalectomy

Surgical removal of patients with unilateral primary aldosteronism in patients selected by the presence of a genetic variant and hypertension

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• patients that participated in the SCAPIS study
• patients that have a particular genetic variant
• patients that have hypertension

Exclusion Criteria

• patients who do not want to participate
• patients who cannot give consent
• patients who are too sick to be operated

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Linkoeping University

OTHER_GOV

Sponsor Role: lead

Responsible Party

Oliver Gimm

Professor of Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Oliver Gimm, MD, Professor

Role: CONTACT

oliver.gimm@liu.se

+46-10-1033022

Other Identifiers

Dnr 2024-07874-01

Identifier Type: -

Identifier Source: org_study_id