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Primary Aldosteronism in Western Norway

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ClinicalTrials.gov Identifier: NCT02832388
Recruitment Status : Recruiting
First Posted : July 14, 2016
Last Update Posted : December 4, 2020
Sponsor:
Collaborators:
Oslo University Hospital
Helse Stavanger HF
Helse Fonna
University Hospital of North Norway
St. Olavs Hospital
Alesund Hospital
Information provided by (Responsible Party):
Haukeland University Hospital

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 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.


Condition or disease
Hyperaldosteronism

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.

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Primary Aldosteronism: a Study of Diagnostic Approach and Treatment Outcome in Western Norway
Study Start Date : June 2013
Estimated Primary Completion Date : December 2030
Estimated Study Completion Date : December 2030

Resource links provided by the National Library of Medicine


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 2020 onwards, PA patients diagnosed or subtyped at Oslo University hospital will also be included.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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. 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.

  4. 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. 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

  6. 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

  7. 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.


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.


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02832388


Contacts
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Contact: Marianne A Grytaas, MD PhD +4741545435 marianne.grytaas@helse-bergen.no
Contact: Kristian Løvås, Prof., MD +4755977996 kristian.lovas@helse-bergen.no

Locations
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Norway
Haukeland University Hospital Recruiting
Bergen, Norway, 5021
Contact: Marianne Grytaas, MD    +4755970503    marianne.grytaas@helse-bergen.no   
Contact: Kristian Løvås, Prof., MD       kristian.lovas@helse-bergen.no   
Oslo University Hospital Not yet recruiting
Oslo, Norway, 0424
Sponsors and Collaborators
Haukeland University Hospital
Oslo University Hospital
Helse Stavanger HF
Helse Fonna
University Hospital of North Norway
St. Olavs Hospital
Alesund Hospital
Investigators
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Principal Investigator: Marianne A Grytaas, MD PhD Haukeland University Hospital
Study Director: Anders P Jørgensen, MD PhD Oslo University Hospital
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Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT02832388    
Other Study ID Numbers: 2013/742
First Posted: July 14, 2016    Key Record Dates
Last Update Posted: December 4, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Hyperaldosteronism
Adrenocortical Hyperfunction
Adrenal Gland Diseases
Endocrine System Diseases