Actively Recruiting
Dynamic Hormone Profiling and Multimodal Data Capture in Primary Aldosteronism
Led by Haukeland University Hospital · Updated on 2024-07-11
80
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
H
Haukeland University Hospital
Lead Sponsor
U
University of Bergen
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to develop a new diagnostic method for primary aldosteronism (PA), a common cause of secondary hypertension with higher risk of organ damage if left untreated. The study focuses on evaluating dynamic multisteroid adrenal hormone patterns using 24-hour microdialysis in patients suspected or confirmed to have PA. The goal is to create a sensitive, fast, and easy-to-use diagnostic process by combining hormone profiling with monitoring of blood pressure, tissue glucose, sleep, activity, and food intake. Participants will use the U-Rhythm microdialysis system to collect subcutaneous tissue fluid for 24 hours. This device captures dynamic hormone levels, which are then analyzed using advanced laboratory techniques. Data collection occurs during daily activities and specific diagnostic tests like saline infusion and dexamethasone suppression. Some participants may undergo repeated sampling after treatment to assess changes over time. During the study, participants will have simultaneous monitoring of blood pressure, glucose, sleep patterns, activity levels, and meals alongside hormone sampling. Researchers will measure hormone rhythmicity and its relationship with these factors, including effects of diagnostic tests and cortisol co-secretion. The main outcome is to assess the rhythmic hormone patterns from 2024 to 2028. The study lasts several years, with ongoing data collection to understand hormone fluctuations and improve PA diagnosis.
CONDITIONS
Brief Title
Dynamic Hormone Profiling and Multimodal Data Capture in Primary Aldosteronism
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 70 years
- Suspected primary aldosteronism admitted for diagnostic saline infusion testing or confirmed diagnosis based on Endocrine Society criteria
- Able to provide written informed consent
You will not qualify if you...
- Age below 18 or above 70 years
- Pregnancy
- Known adrenal failure
- Currently on steroid therapy (oral, inhaled, parenteral, or topical) or other medications affecting hormone levels that could interfere with the study
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to several days depending on testing schedule
Participants undergo 24-hour dynamic microdialysis sampling from subcutaneous tissue fluid and simultaneous measurements of blood pressure, glucose, activity level, meals, and sleep pattern during various testing conditions including daily life activities, saline infusion suppression testing, and dexamethasone suppression testing.
1 to 3 visits for microdialysis sampling and testing
Duration - Up to several years until study completion in 2028
Participants may undergo repeated microdialysis sampling and assessments post treatment to monitor hormone rhythmicity and related parameters over time.
Additional visits depending on post-treatment follow-up schedule
Trial Site Locations
Total: 1 location
1
Haukeland University Hospital
Bergen, Norway, 5021
Actively Recruiting
Research Team
M
Marianne Aardal Grytaas, MD PhD
K
Kristian Løvås, MD PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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