NCT05766085

Brief Summary

The goal of this observational study is to evaluate, between patients with arterial hypertension and non hypertensive control group,

  • the prevalence of hidden hypercortisolism
  • the relationship between organ damage and oxidative stress level, cortisol secretion degree, sensitivity and peripheral activity

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
290

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 15, 2021

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

February 27, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 13, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

March 13, 2023

Status Verified

March 1, 2023

Enrollment Period

2.8 years

First QC Date

February 27, 2023

Last Update Submit

March 10, 2023

Conditions

HypercortisolismArterial Hypertension

Keywords

hypertensionhidden hypercortisolismhypercortisolismcortisol sensitivity

Outcome Measures

Primary Outcomes (1)

  • Prevalence of hidden hypercortisolism (HidHyCo)

    The presence of HidHyCo will be evaluated through the determination of cortisol levels at 9.00 am after taking 1 mg of dexamethasone the previous evening at 11.00 pm (1mgDST). In case of 1mgDST \>1.8 µg/dL the patient will repeat the test and, if the result is confirmed, the patients is considered to have HidHyCo.

    At baseline

Secondary Outcomes (5)

  • Evaluation of organ damage

    At baseline

  • Evaluation of oxidative stress level

    At baseline

  • Evaluation of cortisol secretion degree

    At baseline

  • Evaluation of glucocorticoid sensitivity

    At baseline

  • Evaluation of glucocorticoid peripheral activity

    At baseline

Study Arms (2)

hypertension

Those patients suffering from arterial hypertension

Diagnostic Test: Dexamethasone suppression test

no hypertension

Those patients without arterial hypertension

Diagnostic Test: Dexamethasone suppression test

Interventions

Dexamethasone suppression testDIAGNOSTIC_TEST

Determination of cortisol levels at 9.00 am after taking 1 mg of dexamethasone the previous evening at 11.00 pm (1mg DST)

hypertensionno hypertension

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Hypertension group: patients with hypertension referred to the cardiology clinics of Istituto Auxologico Italiano, Milan No hypertension group: patients without hypertension referred to endocrinology clinics of Istituto Auxologico Italiano for other diseases (e.g. euthyroid nodular goiter or chronic lymphocytic euthyroid thyroiditis)

You may qualify if:

  • Hypertension group: arterial hypertension
  • No hypertension group: absence of arterial hypertension

You may not qualify if:

  • body mass index (BMI) \>30 kg/m2
  • active smoking (\>20 cigarettes/day)
  • pregnancy/lactation
  • hypertension associated with family history of hypertension and cerebrovascular events before 40 years of age
  • sleep apnea
  • hypertension appearance in pre-pubertal age
  • hypokalemia
  • hypertension in the setting of an incidental adrenal mass
  • classic signs and symptoms of hypercortisolism (lunar facies, striae, hypertrichosis, skin atrophy, hump)
  • proven endocrine hypertension (pheochromocytoma, hyperaldosteronism, hyperparathyroidism, acromegaly, hyperthyroidism)
  • renovascular hypertension
  • diseases or conditions associated with increased activity of the hypothalamic-pituitary- adrenal axis and/or oxidative stress, such as type 2 diabetes, rheumatoid arthritis, severe rheumatic/autoimmune diseases, severe hematological diseases, alcoholism, depressive syndrome, chronic renal failure (GFR \<45 ml/min), severe hypovitaminosis D (25OHvitaminD \<10 ng/dL)
  • therapies that interfere with the activity of the HPA axis (i.e. glucocorticoids, antidepressants).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Auxologico Italiano IRCCS

Milan, MI, 20145, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma and serum

MeSH Terms

Conditions

Cushing SyndromeHypertension

Condition Hierarchy (Ancestors)

Adrenocortical HyperfunctionAdrenal Gland DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Carmen Aresta, MD

    Istituto Auxologico Italiano IRCCS

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Carmen Aresta, MD

CONTACT

+3902619112506c.aresta@auxologico.it

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2023

First Posted

March 13, 2023

Study Start

April 15, 2021

Primary Completion

February 1, 2024

Study Completion

February 1, 2024

Last Updated

March 13, 2023

Record last verified: 2023-03

Locations

IT(1)