Primary Aldosteronism in Western Norway
ConditionHyperaldosteronism
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-85
SponsorHaukeland University Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Verified diagnosis or strong suspicion of primary aldosteronism
Age 18-85
Disqualifiers
Active cancer disease at time of inclusion
Asthma/chronic obstructive pulmonary disease ,
Use of dipyridamole
Claustrophobia
Trial population
Patients with primary aldosteronism diagnosed or subtyped at Haukeland University hospital from 2013 onwards. From Autumn 2020 onwards, patients diagnosed or subtyped at Oslo University Hospital are additionally included.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
300 Participants
are grouped into 3 trial groupsGroup A: Primary aldosteronism patients for cardiac MRI
Group B: Healthy controls
Group C: Primary aldosteronism patients diagnosed from 2013 onwards
Trial outcomes
Primary outcomes
1
Long-term clinical outcome after surgical and medical treatment of PA
Systolic and diastolic blood pressure (mm Hg) will be measured after specific PA treatment for estimation of clinical blood pressure outcome. In adrenalectomized patients clinical outcome will be determined following the international standardized Primary Aldosteronism Surgery Outcome (= PASO) criteria.
Time frame
5 years2
Long-term biochemical outcome after surgical treatment of PA
Biochemical outcome after unilateral adrenalectomy will be determined by measurement of aldosterone (pmol/L), direct renin-concentration (mIE/L) for estimation of aldosterone/renin-ratio and potassium (mmol/L) in blood, following the international standardized PASO (primary aldosteronism surgery outcome) criteria.
Time frame
5 yearsSecondary outcomes
1
Echocardiographic assessment of left ventricular mass in PA patients before and after treatment
Echocardiography is applied to assess the rate of increased left ventricular mass (g/m2.7 )before and after specific PA treatment. Data will be compared with a control group of patients with primary hypertension (HT), participating in the FAT-associated CardiOvasculaR dysfunction (FATCOR) study, which is a study cohort established at the European Society of Hypertension Excellence Centre in Bergen.
Time frame
3 years2
Echocardiographic assessment of left ventricular systolic function measured as global longitudinal strain in PA patients before and after treatment
Echocardiography is applied to assess the rate of reduced left ventricular systolic myocardial function assessed as global longitudinal strain, before and after specific PA treatment. Data will be compared with a control group of primary hypertension participating in the FAT-associated CardiOvasculaR dysfunction (FATCOR) study, which is a study cohort established at the European Society of Hypertension Excellence Centre in Bergen.
Time frame
3 years3
Echocardiographic assessment of left ventricular systolic function measured as midwall shortening in PA patients before and after treatment
Echocardiography is applied to assess the rate of reduced left ventricular systolic myocardial function before and after specific PA treatment, measured as midwall shortening (%). Data will be compared with a control group of primary hypertension participating in the FAT-associated CardiOvasculaR dysfunction (FATCOR) study, which is a study cohort established at the European Society of Hypertension Excellence Centre in Bergen.
Time frame
3 years4
Incidence of reduced quality of life in PA patients before and after treatment, assessed by Short Form Health Surveys (SF-36/RAND-36)
Quality of life is measured in PA patients before, 1 year and 5 years after specific PA treatment, measured by the approved quality of life Short Form Health Surveys SF-36 and RAND-36, to detect the incidence of reduced quality of life compared with results from the healthy population. SF-36 was used in the period 2013-2016, and has from 2016 onwards been replaced by RAND-36.
Time frame
5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Haukeland University Hospital
Lead sponsor
Oslo University Hospital
Collaborator
Helse Stavanger HF
Collaborator
Helse Fonna
Collaborator
University Hospital of North Norway
Collaborator
St. Olavs Hospital
Collaborator
Alesund Hospital
Collaborator
Source ClinicalTrials.gov