Primary Aldosteronism in Western Norway

NCT ID: NCT02832388

Last Updated: 2024-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-06-30

Study Completion Date

2030-12-31

Brief Summary

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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

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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.

Conditions

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Hyperaldosteronism

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Primary aldosteronism patients for cardiac MRI

A subgroup of primary aldosteronism (PA) patients perform a cardiac MRI, including stress-testing with adenosine, and are compared to a sex- and age-matched group of healthy controls who perform the same MRI procedure

No interventions assigned to this group

Healthy controls

Healthy controls that are age-and sex-matched to the subgroup of PA patients performing cardiac MRI, perform MRI including adenosine as stress-test.

No interventions assigned to this group

Primary aldosteronism patients diagnosed from 2013 onwards

All PA patients diagnosed or subtyped at Haukeland University from 2013 onwards are asked for inclusion in the main observational PA-study.

From 2025 onwards, PA patients diagnosed or subtyped at Oslo University hospital will also be included.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Verified diagnosis or strong suspicion of primary aldosteronism
* Age 18-85

Exclusion Criteria

* Active cancer disease at time of inclusion


* Asthma/chronic obstructive pulmonary disease ,
* Use of dipyridamole
* Claustrophobia
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Oslo University Hospital

OTHER

Sponsor Role collaborator

Helse Stavanger HF

OTHER_GOV

Sponsor Role collaborator

Helse Fonna

OTHER

Sponsor Role collaborator

University Hospital of North Norway

OTHER

Sponsor Role collaborator

St. Olavs Hospital

OTHER

Sponsor Role collaborator

Alesund Hospital

OTHER

Sponsor Role collaborator

Haukeland University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marianne A Grytaas, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Haukeland University Hospital

Anders P Jørgensen, MD PhD

Role: STUDY_DIRECTOR

Oslo University Hospital

Locations

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Haukeland University Hospital

Bergen, , Norway

Site Status RECRUITING

Oslo University Hospital

Oslo, , Norway

Site Status NOT_YET_RECRUITING

Countries

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Norway

Central Contacts

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Marianne A Grytaas, MD PhD

Role: CONTACT

+4741545435

Kristian Løvås, Prof., MD

Role: CONTACT

+4755977996

Facility Contacts

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Marianne Grytaas, MD

Role: primary

+4755970503

Kristian Løvås, Prof., MD

Role: backup

Other Identifiers

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2013/742

Identifier Type: -

Identifier Source: org_study_id

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