Primary Aldosteronism in Western Norway

NCT02832388 | Recruiting

• 1 other identifier: 2013/742
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 2

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.

Conditions

Hyperaldosteronism

Outcome Measures

Primary Outcomes (2)

• 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.

  5 years

• 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.

  5 years

Secondary Outcomes (7)

• Echocardiographic assessment of left ventricular mass in PA patients before and after treatment

  3 years

• Echocardiographic assessment of left ventricular systolic function measured as global longitudinal strain in PA patients before and after treatment

  3 years

• Echocardiographic assessment of left ventricular systolic function measured as midwall shortening in PA patients before and after treatment

  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)

  5 years

• Cardiac MRI assessment of left ventricular mass in PA patients before and after treatment

  3 years

Study Arms (3)

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

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.

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.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Asthma/chronic obstructive pulmonary disease ,
• Use of dipyridamole
• Claustrophobia

Sponsors & Collaborators

• Haukeland University Hospital: lead
• Oslo University Hospital: collaborator
• Helse Stavanger HF: collaborator
• Helse Fonna: collaborator
• University Hospital of North Norway: collaborator
• St. Olavs Hospital: collaborator
• Alesund Hospital: collaborator

Study Sites (2)

Haukeland University Hospital

Bergen, 5021, Norway

RECRUITING

Oslo University Hospital

Oslo, 0424, Norway

NOT YET RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood and urine samples are collected from each study participants for routine biochemistry and for biopanning. Additional saliva and hair samples may be sampled.

MeSH Terms

Conditions

Hyperaldosteronism

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases

Study Officials

• Marianne A Grytaas, MD PhD

  Haukeland University Hospital

  PRINCIPAL INVESTIGATOR

• Anders P Jørgensen, MD PhD

  Oslo University Hospital

  STUDY DIRECTOR

Central Study Contacts

Marianne A Grytaas, MD PhD

CONTACT

+4741545435; marianne.grytaas@helse-bergen.no

Kristian Løvås, Prof., MD

CONTACT

+4755977996; kristian.lovas@helse-bergen.no

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2016
• First Posted: July 14, 2016
• Study Start: June 1, 2013
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: November 8, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

NO (2)