Actively Recruiting

Age: 18Years - 85Years
All Genders
Healthy Volunteers
ID02832388

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

Led by Haukeland University Hospital · Updated on 2024-11-08

300

Participants Needed

2

Research Sites

N/A

Total Duration

On this page

Sponsors

H

Haukeland University Hospital

Lead Sponsor

O

Oslo University Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying patients with primary aldosteronism (PA) in Western and Mid-parts of Norway to understand the characteristics of these patients, the effects of PA on the heart before and after treatment, and long-term outcomes after treatment. The study includes a national registration of PA patients diagnosed or subtyped at Oslo University Hospital starting from 2022. This observational study aims to provide detailed information about PA and its treatment outcomes over time. Patients diagnosed with PA at Haukeland University Hospital since June 2013 are invited to join the study. Participants have baseline visits for clinical data registration and collection of blood and urine samples. A subgroup undergoes echocardiography before and one year after specific medical or surgical treatment for PA. Another subgroup participates in a cardiac MRI study using various imaging techniques including stress testing with adenosine, compared with healthy, age- and sex-matched controls. From 2025, PA patients diagnosed or subtyped at Oslo University Hospital will also be included. Participants attend regular follow-up visits after beginning treatment to monitor changes. The study measures long-term clinical and biochemical outcomes over five years, as well as heart function and structure using echocardiography and cardiac MRI over three years. Quality of life is also assessed. Healthy controls participate in the cardiac MRI substudy for comparison. The total participation time varies depending on the patient's subgroup and assessments.

CONDITIONS

Brief Title

Primary Aldosteronism in Western Norway

Who Can Participate

Age: 18Years - 85Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Verified diagnosis or strong suspicion of primary aldosteronism
  • Age 18-85
Not Eligible

You will not qualify if you...

  • Active cancer disease at time of inclusion
  • Asthma or chronic obstructive pulmonary disease for cardiac MRI subgroup
  • Use of dipyridamole for cardiac MRI subgroup
  • Claustrophobia for cardiac MRI subgroup

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Baseline visit

Participants undergo baseline clinical assessments and sample collections. Echocardiography is performed in a subgroup before treatment starts. A subgroup also undergoes cardiac MRI including stress testing with adenosine.

1 baseline visit (in-person)

Long-term Monitoring

Duration - Up to 5 years

Participants are followed up regularly after starting medical or surgical treatment, with clinical and biochemical assessments and repeated echocardiography or cardiac MRI in subgroups to assess treatment outcomes.

Regular follow-up visits over 5 years

Trial Site Locations

Total: 2 locations

1

Haukeland University Hospital

Bergen, Norway, 5021

Actively Recruiting

2

Oslo University Hospital

Oslo, Norway, 0424

Not Yet Recruiting

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Research Team

M

Marianne A Grytaas, MD PhD

K

Kristian Løvås, Prof., MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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