NCT02364089

Brief Summary

The general objective is to evaluate the consequences of surgical removal of SCSI on hypertension and cardiovascular risk factors in order to determine on an evidence-based basis if surgical excision of SCSI is preferable to an intensive medical regimen in patients with hypertension.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2015

Longer than P75 for not_applicable

Geographic Reach
3 countries

17 active sites

Status
completed

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

First Submitted

Initial submission to the registry

January 28, 2015

Completed
19 days until next milestone

First Posted

Study publicly available on registry

February 16, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

April 9, 2015

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 9, 2022

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 23, 2022

Completed
Last Updated

July 20, 2023

Status Verified

July 1, 2023

Enrollment Period

6.9 years

First QC Date

January 28, 2015

Last Update Submit

July 18, 2023

Conditions

Adrenal Incidentalomas

Keywords

Adrenal IncidentalomaSubclinical Cushing's syndromeHypertensionCardiovascular Risk FactorsMetabolic SyndromeSurgery of adrenal tumor

Outcome Measures

Primary Outcomes (1)

  • Blood pressure value and SAHR step 12 months after inclusion

    Treatment response will defined as a reduction of at least 1 step of SAHR at the end of the study, with BP maintained within the study objectives (\<135 mm Hg systolic and \<85 mm Hg diastolic) according to self-measurement at home.

    13 months

Secondary Outcomes (10)

  • Antihypertensive treatment score and daily drug dose

    12 months

  • Incidence of complications in the two strategies.

    12 months

  • Direct costs of the two strategies.

    12 months

  • Assessment of predictive factors for the success of surgery on BP

    12 months

  • number of patients requiring antihypertensive treatment

    12 months

  • +5 more secondary outcomes

Study Arms (2)

Surgery followed by intensive medical care

EXPERIMENTAL

Laparoscopic surgical removal of the adrenal tumor

Procedure: Laparoscopic surgical removal of the adrenal tumor

Intensive medical treatment only

ACTIVE COMPARATOR

Standardized medical treatment of hypertension by SAHR.

Drug: Standardized medical treatment of hypertension by SAHR

Interventions

Laparoscopic surgical removal of the adrenal tumorPROCEDURE
Surgery followed by intensive medical care
Standardized medical treatment of hypertension by SAHRDRUG

Standardized anti-hypertensive drug regimen has been established according to international recommendations and includes the following steps: * step 1: Angiotensin converting enzyme inhibitor (ACE-I) or angiotensin II receptor antagonist (ARBs) at half-dose (Ranipril 5mg or Ibesartan 150 mg ) * step 2: CEI or ARA2 at full dose (Ranipril 10 mg or Ibesartan 300 mg) * step 3: Add-on of Amlodipine 10 mg or Diltiazem LP 300 mg * step 4: Add-on of Indapamide LP 1.5 mg * step 5: Add-on of Spironolactone 25 mg * step 6: Add-on of Bisoprolol 10 mg * step 7: Add-on of Prazosine LP 5mg/day.

Intensive medical treatment only

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≤ 80 years.
  • Unilateral SCSI:
  • Incidentally discovered adrenal tumor with attenuation \< 20 UH and/or relative wash-out (\> 40%) or absolute wash-out (\> 60%) of contrast media and size ≥ 2 cm. Tumors that do not fulfil these criteria might be included if their size is ≤ 4 cm, do not exhibit signs of malignancy (necrosis areas, large and irregular rims) and are stable in size after ≥ 6 months of follow-up.
  • Impaired 1 mg dexamethasone suppression (Cortisol \> 138 nmol/L or 5 µg/dL), OR Impaired 1 mg dexamethasone suppression (Cortisol \> 50 nmol/L or 1.8 µg/dL) AND one biochemical abnormalities among:
  • h00 plasma ACTH \< 2.2 pmol/L or plasma ACTH following CRH injection ≤ 6.6 pmol/L,
  • midnight plasma cortisol \> 150 nmol/L,
  • increased late evening salivary cortisol,
  • UFC between 1 and 2.0 x N.
  • Treated BP (and confirmed using an automated home BP monitoring) OR increased BP (≥ 135/85 mmHg) none treated, using an automated home BP monitoring.

You may not qualify if:

  • Age \> 80 y,
  • Bilateral SCSI, Warning: Contralateral nodular formations \< 10 mm are considered as negligible,
  • Incidentally discovered adrenal tumor size \< 2 cm,
  • Malignant hypertension, stroke, pulmonary oedema or myocardial infarction during the previous year,
  • Malignant hypertension during the Run-in period,
  • Obligatory beta blocker treatment. Patients receiving betablocker treatment for other purpose than hypertension can be included. However, to be included, patients should need at least an extrastep of hypertensive treatment in order to allow the SAHR decrease following randomisation. The dose of betablocker has to stay the same during all the study.
  • UFC \> ULN x 2.0 N,
  • h00 plasma ACTH \> 20 pg/ml (4.4 pmol/L),
  • Chronic renal insufficiency (clearance \< 30 mL/min)
  • Dissipation of the biological endocrine criteria for SCSI at the end of the Run-In period,
  • Intake of exogenous corticoids or drugs that interfere with dexamethasone metabolism,
  • Pregnancy,
  • Childbearing woman with no contraceptive effective method (HAS criteria - 77),
  • Adverse pathological conditions responsible for reduced life expectancy.
  • Spontaneous resolution of biological features of SCSI
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Service de Médecine Interne, Endocrinologie et Nutrition - CHU de Strasbourg

Strasbourg, Alsace, 67000, France

Location

Service Endocrinologie, Diabétologie, maladies métaboliques - CHU de Bordeaux

Pessac, Aquitaine, 33600, France

Location

Service d'Endocrinologie - Niveau 18 - Caen CHU Côte de Nacre

Caen, Basse-Normandie, 14000, France

Location

Service d'Endocrinologie, Diabétologie, Nutrition - CHU d'Amiens

Amiens, Haut de France, 80000, France

Location

Endocrinologie, Diabète et Maladies Métaboliques - CHU de Rouen

Rouen, Haute-Normandie, 76000, France

Location

Service d'Endocrinologie, Diabétologie et Métabolisme - CHRU de LILLE

Lille, Hauts-de-France, 59000, France

Location

Service d'Endocrinologie et Maladies Métabolique - CHU de Toulouse

Toulouse, Midi-Pyrénées, 31000, France

Location

Département Endocrinologie-Diabétologie -Nutrition - CHU d'ANGERS

Angers, Pays de la Loire Region, 49000, France

Location

CIC Endocrinologie-Nutrition - CHU de Nantes

Nantes, Pays de la Loire Region, 44000, France

Location

Service d'Endocrinologie, Diabète et Maladies Métaboliques - Assistance publique - Hôpitaux de Marseille

Marseille, Provence-Alpes-Côte d'Azur Region, 13000, France

Location

CHU de Poitiers

Poitiers, 86021, France

Location

Service d'Endocrinologie et des Maladies de la Reproduction- Assistance Publique - Hôpitaux de Paris - Hôpial Bicêtre

Le Kremlin-Bicêtre, Île-de-France Region, 94275, France

Location

Assistance Publique - Hôpitaux de Paris - Hôpital COCHIN

Paris, Île-de-France Region, 75014, France

Location

Service d'Hypertension et de Médecine Vasculaire - Assistance Publique - Hôpitaux de Paris - Hôpital européen Georges Pompidou

Paris, Île-de-France Region, 75908, France

Location

Endokrinologie, Diabetes und Ernährungsmedizin, Campus Mitte, Medizinische Klinik - Charité - Universitätsmedizin Berlin

Berlin, 10117, Germany

Location

Department of Internal Medicine I, Endocrine and Diabetes Uni -University Hospital Würzburg

Würzburg, 97080, Germany

Location

S Orsola-Malpighi Hospital

Bologna, 40138, Italy

Location

Related Publications (1)

  • Tabarin A, Espiard S, Deutschbein T, Amar L, Vezzossi D, Di Dalmazi G, Reznik Y, Young J, Desailloud R, Goichot B, Drui D, Assie G, Lefebvre H, Mai K, Castinetti F, Laboureau S, Terzolo M, Ferriere A, Georget A, Frison E, Vantyghem MC, Fassnacht M, Gosse P; CHIRACIC Collaborators. Surgery for the treatment of arterial hypertension in patients with unilateral adrenal incidentalomas and mild autonomous cortisol secretion (CHIRACIC): a multicentre, open-label, superiority randomised controlled trial. Lancet Diabetes Endocrinol. 2025 Jul;13(7):580-590. doi: 10.1016/S2213-8587(25)00062-2. Epub 2025 May 12.

    PMID: 40373786DERIVED

MeSH Terms

Conditions

Adrenal incidentalomaHypertensionMetabolic Syndrome

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Eric FRISON, Dr

    University Hospital, Bordeaux

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2015

First Posted

February 16, 2015

Study Start

April 9, 2015

Primary Completion

March 9, 2022

Study Completion

November 23, 2022

Last Updated

July 20, 2023

Record last verified: 2023-07

Locations

IT(1)DE(2)FR(14)