Genetic Predisposition to High Blood Pressure

NCT07181213 | Enrolling By Invitation

• 1 other identifier: Dnr 2024-07874-01
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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, the investigators 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. The investigators 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. The investigators now want to investigate the following:

1. 1.identify those persons with the genetic variant and HT that have PA,
2. 2.identify those persons with PA that have APAs/unilateral disease,
3. 3.identify how many patients with APAs/unilateral disease can be cured by surgery.

Conditions

Hypertension; Primary Aldosteronism; Genetic Predisposition to Disease

Outcome Measures

Primary Outcomes (1)

• Normal aldosterone-renin-ratio

  6 months following surgery

Secondary Outcomes (3)

• Blood pressure both systolic and diastolic

  6 months after surgery

• Number of antihypertensive drugs

  6 months following surgery

• Normal potassium level

  6 months postoperatively

Study Arms (2)

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

ACTIVE COMPARATOR

Unilateral adrenalectomy is offered

Procedure: Adrenalectomy

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

NO INTERVENTION

Medical treatment is offered

Interventions

Adrenalectomy PROCEDURE

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

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

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Linkoeping University: lead

Study Sites (1)

Linköping University Hospital

Linköping, Östergötland County, 58185, Sweden

Location

MeSH Terms

Conditions

Hypertension; Hyperaldosteronism; Genetic Predisposition to Disease

Interventions

Adrenalectomy

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases; Disease Susceptibility; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endocrine Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Study Record Dates

• First Submitted: September 12, 2025
• First Posted: September 18, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

SE (1)