Primary Aldosteronism in Western Norway

Hyperaldosteronism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02832388
• Other study ID #: 2013/742
• Status: Recruiting
• Start date: June 2013
• Est. completion date: December 2030

Study information

• Verified date: September 2023
• Source: Haukeland University Hospital
• Contact: Marianne A Grytaas, MD PhD
• Phone: +4741545435
• Email: marianne.grytaas[@]helse-bergen.no
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2030
• Est. primary completion date: December 2030
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Hyperaldosteronism

Locations

Country	Name	City	State
Norway	Haukeland University Hospital	Bergen
Norway	Oslo University Hospital	Oslo

Sponsors (7)

Lead Sponsor	Collaborator
Haukeland University Hospital	Alesund Hospital, Helse Fonna, Helse Stavanger HF, Oslo University Hospital, St. Olavs Hospital, University Hospital of North Norway

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Echocardiographic assessment of left ventricular mass in PA patients before and after treatment	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
Secondary	Echocardiographic assessment of left ventricular systolic function measured as global longitudinal strain in PA patients before and after treatment	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
Secondary	Echocardiographic assessment of left ventricular systolic function measured as midwall shortening in PA patients before and after treatment	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
Secondary	Incidence of reduced quality of life in PA patients before and after treatment, assessed by Short Form Health Surveys (SF-36/RAND-36)	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
Secondary	Cardiac MRI assessment of left ventricular mass in PA patients before and after treatment	Cardiac MRI is performed to assess change of left ventricular mass after specific PA treatment	3 years
Secondary	Cardiac MRI assessment of myocardial fibrosis in PA patients compared with healthy controls	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
Secondary	Cardiac MRI assessment of left coronary flow reserve	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