Primary Aldosteronism in Western Norway

September 22, 2023 updated by: Haukeland University Hospital

Primary Aldosteronism: a Study of Diagnostic Approach and Treatment Outcome in Western Norway

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.

Study Overview

Status

Recruiting

Conditions

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 2020 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 2020 onwards, PA patients either diagnosed or performing subtyping with adrenal vein sampling at Oslo University Hospital will likewise be asked for study inclusion.

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 2022 onwards, PA patients diagnosed or subtyped at Oslo University hospital will also be included.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Long-term clinical outcome after surgical and medical treatment of PA
Time Frame: 5 years
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
Time Frame: 5 years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Echocardiographic assessment of left ventricular mass in PA patients before and after treatment
Time Frame: 3 years
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.
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
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.
3 years
Echocardiographic assessment of left ventricular systolic function measured as midwall shortening in PA patients before and after treatment
Time Frame: 3 years
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.
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
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.
5 years
Cardiac MRI assessment of left ventricular mass in PA patients before and after treatment
Time Frame: 3 years
Cardiac MRI is performed to assess change of left ventricular mass after specific PA treatment
3 years
Cardiac MRI assessment of myocardial fibrosis in PA patients compared with healthy controls
Time Frame: 3 years
Cardiac MRI with T1 mapping is performed to assess the presence of cardiac fibrosis in PA patients before and after specific PA treatment, compared with a control group of healthy controls
3 years
Cardiac MRI assessment of left coronary flow reserve
Time Frame: 3 years
Stress testing during cardiac MRI is performed in PA patients and a control group of healthy controls to assess the rate of reduced coronary flow reserve in PA patients before and after specific PA treatment, compared with a control group of healthy controls.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Marianne A Grytaas, MD PhD, Haukeland University Hospital
  • Study Director: Anders P Jørgensen, MD PhD, Oslo University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2030

Study Registration Dates

First Submitted

January 25, 2016

First Submitted That Met QC Criteria

July 11, 2016

First Posted (Estimated)

July 14, 2016

Study Record Updates

Last Update Posted (Actual)

September 25, 2023

Last Update Submitted That Met QC Criteria

September 22, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 2013/742

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hyperaldosteronism

Subscribe