Primary Aldosteronism in Western Norway
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
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Hyperaldosteronism. Basic parameters: 18 years — 85 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
- Norway
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Primary Aldosteronism: a Study of Diagnostic Approach and Treatment Outcome in Western Norway
Overview
In this study the investigators aim to identify and include consecutively patients with primary aldosteronism (PA) diagnosed in the Western and Mid-parts of Norway, to describe the characteristics of these patients, to explore the cardiac effects of PA before and after specific treatment, and to identify long-term outcomes after treatment. One subgroup of the PA patients perform echocardiography to assess left ventricular systolic myocardial function before and after treatment. One subgroup of PA patients perform cardiac MRI to assess myocardial mass, myocardial fibrosis and myocardial function in rest and during stress, before and after treatment. For the cardiac MRI substudy, the PA patients are compared with a group of healthy controls, also included in the study. From 2022 onwards, PA patients diagnosed or subtyped with adrenal vein sampling at Oslo University Hospital will additionally be included in the study, thereby providing a national registration of PA patients.
Detailed description
From June 2013, all newly diagnosed patients with primary aldosteronism (PA) either diagnosed at Haukeland University Hospital (HUS) or admitted to HUS for subtype testing with adrenal vein sampling, have been asked for inclusion in the study. All included patients have a base-line study visit where clinical information is registered, and baseline blood and urine samples are collected. Echocardiography will be performed in a subgroup of patients before and 1 year after start of specific PA treatment. After start of definite medical or surgical treatment the patients are followed up with regularly new study visits. From 2025 onwards, PA patients diagnosed or subtyped with adrenal vein sampling at Oslo University Hospital will additionally be included in the study, thereby providing a national registration of PA patients.
A subgroup of the included PA study patients also perform a Cardiac MRI. Cine-MRI, velocity-encoded MRI, MRI images during continuous adenosine infusion and MRI images after gadolinium contrast injection are performed, and compared to a group of age- and sex-matched healthy controls.
From 2025 onwards, PA patients either diagnosed or performing subtyping with adrenal vein sampling at Oslo University Hospital will likewise be asked for study inclusion.
Primary outcome measures
- Long-term clinical outcome after surgical and medical treatment of PA [Time frame: 5 years]
- Long-term biochemical outcome after surgical treatment of PA [Time frame: 5 years]
Secondary outcome measures (7)
- Echocardiographic assessment of left ventricular mass in PA patients before and after treatment [Time frame: 3 years]
- Echocardiographic assessment of left ventricular systolic function measured as global longitudinal strain in PA patients before and after treatment [Time frame: 3 years]
- Echocardiographic assessment of left ventricular systolic function measured as midwall shortening in PA patients before and after treatment [Time frame: 3 years]
- Incidence of reduced quality of life in PA patients before and after treatment, assessed by Short Form Health Surveys (SF-36/RAND-36) [Time frame: 5 years]
- Cardiac MRI assessment of left ventricular mass in PA patients before and after treatment [Time frame: 3 years]
- Cardiac MRI assessment of myocardial fibrosis in PA patients compared with healthy controls [Time frame: 3 years]
- Cardiac MRI assessment of left coronary flow reserve [Time frame: 3 years]
Eligibility criteria
Inclusion criteria
- Verified diagnosis or strong suspicion of primary aldosteronism
- Age 18-85
Exclusion criteria
- Active cancer disease at time of inclusion
Exclusion criteria for subgroup of primary aldosteronism-patients and healthy controls who perform cardiac MRI:
- Asthma/chronic obstructive pulmonary disease ,
- Use of dipyridamole
- Claustrophobia
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Norway · 2 centers
- Haukeland University Hospital — Bergen
- Oslo University Hospital — Oslo
Identifiers
NCT: NCT02832388 · 2013/742