Overnight Dexamethasone in Primary Aldosteronism Screening in Patients on Interfering Therapy (the ODEPRASC Study)

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

The goal of this observational study is to learn whether screening for primary aldosteronism can be improved among patients on chronic blood pressure-lowering medications by ordering intake of 1 mg of dexamethasone prior to hormonal examinations. Primary aldosteronism is a condition, in which an adrenal gland steroid aldosterone is released in excessive amounts; it commonly causes hypertension but requires specific therapy different from usually prescribed in other forms of hypertension. Dexamethasone is a synthetic steroid used for both therapeutic and diagnostic purposes. A single 1 mg dexamethasone dose taken at 11 p.m. in order to measure hormone concentrations the following morning (so called overnight 1-mg dexamethasone test) is a commonly applied test in the work-up of adrenal disorders. The main question the project aims to answer is: Can screening for primary aldosteronism be improved among patients receiving blood pressure-lowering medications with overnight 1-mg dexamethasone intake? Participants will undergo changes in their chronic medication to be able to definitely rule out or confirm primary aldosteronism in blood hormonal examinations. These modifications and modifications are not part of the research project. For this project participants will be asked to * undergo the 1-mg dexamethasone test one to three times in order to compare hormonal concentrations before and after it, * collect urine for 24 hours to determine aldosterone in the urine sample after medications interfering in aldosterone release are temporarily withdrawn.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 75
Healthy Volunteers: f
View:

• suspected or diagnosed HT,

• age between 40 and 75,

• available aldosterone and renin result at the time of one-day clinic stay,

• scheduled 1-mg-DXM test (indicated for possible mild autonomous cortisol secretion, MACS),

• presence of an adrenal lesion with radiologic features of adrenocortical adenoma/hyperplasia.

Locations
Other Locations
Poland
Department of Endocrinology and Internal Medicine, University Clinical Center, Medical University of Gdansk
RECRUITING
Gdansk
Contact Information
Primary
Piotr Kmiec, M.D., Ph.D.
piotrkmiec@gumed.edu.pl
0048 585844809
Backup
Renata Swiatkowska-Stodulska, Professor, MD, Ph.D.
rensto@gumed.edu.pl
0049 585844800
Time Frame
Start Date: 2024-10-22
Estimated Completion Date: 2026-10-31
Participants
Target number of participants: 240
Treatments
Post-DXM ARR development cohort
Data from the first half of participants data will be used to generate post-DXM ARR (and possibly Ald) thresholds, which will be subsequently temporally validated in the confirmatory cohort.
Post-DXM ARR confirmatory cohort
Post-DXM ARR thresholds will be applied among participants of the confirmatory cohort, however, these will also undergo the medication withdrawal, OSLT, and other PA confirmatory tests if indicated.
Related Therapeutic Areas
Sponsors
Leads: Medical University of Gdansk

This content was sourced from clinicaltrials.gov