HyperaldosteronismNCT02832388
Primary Aldosteronism in Western Norway
An observational study of Hyperaldosteronism, run by Haukeland University Hospital at 2 sites in Norway.
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… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperaldosteronism
- How many people
- 300 participants
- Where
- 2 sitesNorway
- Study dates
- Jun 2013to Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Verified diagnosis or strong suspicion of primary aldosteronism
- Age 18-85
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Norway2 sites, 2 recruiting
- Recruiting
Haukeland University Hospital
Bergen, 5021
Marianne Grytaas, MD, +4755970503, marianne.grytaas@helse-bergen.no
Kristian Løvås, Prof., MD, kristian.lovas@helse-bergen.no
- Not yet recruiting
Oslo University Hospital
Oslo, 0424
About this study
Official title: 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.
Read the 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 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
- Hyperaldosteronism
- Medical subject headings
- Hyperaldosteronism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 5 years
Secondary outcomes (7)
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.
Measured: 3 years
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.
Measured: 3 years
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.
Measured: 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)
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.
Measured: 5 years
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
Measured: 3 years
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
Measured: 3 years
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2016 (estimated)
- Study startJun 2013
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperaldosteronismStudies of the same condition, open and under way.
- More trials run by Haukeland University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Oslo University Hospital, Helse Stavanger HF, Helse Fonna, University Hospital of North Norway, St. Olavs Hospital, Alesund Hospital
- Responsible party
- Sponsor
- Investigators
- Marianne A Grytaas, MD PhD, Principal investigator, Haukeland University HospitalAnders P Jørgensen, MD PhD, Study director, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02832388
- Sponsor's protocol ID
- 2013/742
- Status last verified
- Nov 2024
- First submitted
- 25 Jan 2016
- Last updated
- 8 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Aldosteronism: a Study of Diagnostic Approach and Treatment Outcome in Western Norway
- ClinicalTrials.gov ID
- NCT02832388
- Acronym / sponsor ID
- 2013/742
- Conditions
- Hyperaldosteronism
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Collaborators
- Oslo University Hospital, Helse Stavanger HF, Helse Fonna, University Hospital of North Norway, St. Olavs Hospital, Alesund Hospital
- Study start
- Jun 2013
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 14 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Verified diagnosis or strong suspicion of primary aldosteronism
- Age 18-85
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
7 secondary outcomes
Echocardiographic assessment of left ventricular mass in PA patients before and after treatment
Time frame: 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
Echocardiographic assessment of left ventricular systolic function measured as midwall shortening in PA patients before and after treatment
Time frame: 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
Cardiac MRI assessment of left ventricular mass in PA patients before and after treatment
Time frame: 3 years
Cardiac MRI assessment of myocardial fibrosis in PA patients compared with healthy controls
Time frame: 3 years
Cardiac MRI assessment of left coronary flow reserve
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marianne A Grytaas, MD PhD principal investigator
Haukeland University Hospital
Anders P Jørgensen, MD PhD study director
Oslo University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperaldosteronism, run by Haukeland University Hospital at 2 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marianne A Grytaas, MD PhD (+4741545435, marianne.grytaas@helse-bergen.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long-term clinical outcome after surgical and medical treatment of PA (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2024.