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NCT03105531Completed

Screening for Primary Aldosteronism in a Population of Patients With Hypertension

Source: ClinicalTrials.gov · Last updated 4 Dec 2023

Brief summary (registry, in English)

Primary aldosteronism (PA) is an under-diagnosed cause of arterial hypertension. Cardiovascular morbidity and mortality in hypertension rises significantly for patients who have aldosterone overproduction when compared with those with primary hypertension and the same level of blod pressure elevation. The classical signs of PA such as severe hypertension and hypokalemia may be absent, why screening in defined risk groups has been recommended. Screening has not been systematically implemented in Sweden, probably due to expensive, time and effort-consuming clinical routine protocols and low awareness of the problem among clinicians. The prevalence of PA in patients with hypertension in Sweden has not been studied adequately, and few studies from Northern Europe have addressed the problem. The primary objective is to investigate prevalence of PA among patients with hypertension in primary care and to implement and assess optimal treatment. Discovered cases of PA will go through routine clinical work-up in order to distinguish the subtype of PA, which includes computed tomography of adrenals and adrenal vein sampling (AVS) in those willing and fit for surgical treatment. Treatment will be then chosen depending on the PA subtype. Those with unilateral disease who are willing and fit for surgery will be offered unilateral minimally invasive adrenalectomy. Patients who oppose or have contraindications to operative treatment, as well as patients with bilateral disease will be offered medical treatment with mineralocorticoid receptor antagonists (MRA). Study participants will be then followed up one year after surgery or initiation of specific medical treatment. Please se outcome measures for relevant description of those. Blood samples will be collected from patients with confirmed PA to be stored in a biobank for potential future genetical and biochemical studies. A subgroup of patients with PA will undergo adrenal-specific positron-emission tomography to assess the possibility to un-invasively diagnose and subtype PA.

Status (registry)
Completed
Study type
Observational
Enrollment
1183 (actual)
First submitted
27 Mar 2017
Start date
7 Apr 2017
Primary completion date
28 Nov 2023
Lead sponsor
Uppsala University
NCT number
NCT03105531

What you commit to

  • Study type: Observational
  • Participants enrolled: 1183
  • From 7 Apr 2017 to the primary completion date, 28 Nov 2023
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • pregnancy

Who the study is looking for

  • participants must have Swedish personal number (that gives right to all kinds of necessary planned health care)

Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Uppsala University, the Department of Surgical Sciences
Coordinator of this site? Confirm its status
UppsalaSwedenUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.