Menu
Enrolling by invitation NCT07181213

Genetic Predisposition to High Blood Pressure

No phase Interventional Hypertension Primary Aldosteronism Genetic Predisposition to Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Adrenalectomy.
Who it may be relevant to
Registry conditions: Hypertension, Primary Aldosteronism, Genetic Predisposition to Disease. Basic parameters: from 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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. 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.

Interventions

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

Primary outcome measures

  • Normal aldosterone-renin-ratio [Time frame: 6 months following surgery]
Secondary outcome measures (3)
  • Blood pressure both systolic and diastolic [Time frame: 6 months after surgery]
  • Number of antihypertensive drugs [Time frame: 6 months following surgery]
  • Normal potassium level [Time frame: 6 months postoperatively]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Single group
Masking
Open label
Primary purpose
Screening

Study locations

Sweden · 1 center
  • Linköping University Hospital — Linköping

Identifiers

NCT: NCT07181213 · Dnr 2024-07874-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗