Clinical trial NCT02832388: Primary Aldosteronism in Western Norway
Official title: Primary Aldosteronism: a Study of Diagnostic Approach and Treatment Outcome in Western Norway
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hyperaldosteronism
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
Collaborators: name: Oslo University Hospital
name: Helse Stavanger HF
name: Helse Fonna
name: University Hospital of North Norway
name: St. Olavs Hospital
name: Alesund Hospital
First posted: 2016-07-14
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study 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.

Brief summary: 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.

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

Primary outcomes:
measure: Long-term clinical outcome after surgical and medical treatment of PA
timeFrame: 5 years
measure: Long-term biochemical outcome after surgical treatment of PA
timeFrame: 5 years
Secondary outcomes:
measure: Echocardiographic assessment of left ventricular mass in PA patients before and after treatment
timeFrame: 3 years
measure: Echocardiographic assessment of left ventricular systolic function measured as global longitudinal strain in PA patients before and after treatment
timeFrame: 3 years
measure: Echocardiographic assessment of left ventricular systolic function measured as midwall shortening in PA patients before and after treatment
timeFrame: 3 years
measure: Incidence of reduced quality of life in PA patients before and after treatment, assessed by Short Form Health Surveys (SF-36/RAND-36)
timeFrame: 5 years
measure: Cardiac MRI assessment of left ventricular mass in PA patients before and after treatment
timeFrame: 3 years
measure: Cardiac MRI assessment of myocardial fibrosis in PA patients compared with healthy controls
timeFrame: 3 years
measure: Cardiac MRI assessment of left coronary flow reserve
timeFrame: 3 years
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Haukeland University Hospital
name: Marianne A Grytaas, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oslo University Hospital
name: Anders P Jørgensen, MD PhD
role: STUDY_DIRECTOR
References: