Adrenal Incidentalomas Clinical Trial
— CHIRACICOfficial title:
Surgery of Subclinical Cortisol Secreting Adrenal Incidentalomas
Verified date | July 2023 |
Source | University Hospital, Bordeaux |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 78 |
Est. completion date | November 23, 2022 |
Est. primary completion date | March 9, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - 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: - 08h00 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. Exclusion Criteria: - 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, - 8h00 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. Exclusion criteria after the Run-In period: - Spontaneous resolution of biological features of SCSI - Hypertension not confirmed with standard blood pressure self-measurement device - Hypertension not controlled (= 135/85 mmHg) at the end of the Run-In period - Malignant hypertension (> 175/115 mmHg) - Patient receiving betablocker and not receiving at least an extrastep of hypertensive treatment of the SAHR |
Country | Name | City | State |
---|---|---|---|
France | Service d'Endocrinologie, Diabétologie, Nutrition - CHU d'Amiens | Amiens | Haut De France |
France | Département Endocrinologie-Diabétologie -Nutrition - CHU d'ANGERS | Angers | Pays De La Loire |
France | Service d'Endocrinologie - Niveau 18 - Caen CHU Côte de Nacre | Caen | Basse-Normandie |
France | Service d'Endocrinologie et des Maladies de la Reproduction- Assistance Publique - Hôpitaux de Paris - Hôpial Bicêtre | Le Kremlin Bicêtre | ILE DE France |
France | Service d'Endocrinologie, Diabétologie et Métabolisme - CHRU de LILLE | Lille | Nord-Pas-de-Calais |
France | Service d'Endocrinologie, Diabète et Maladies Métaboliques - Assistance publique - Hôpitaux de Marseille | Marseille | Provence-Alpes-Côte d'Azur |
France | CIC Endocrinologie-Nutrition - CHU de Nantes | Nantes | Pays De La Loire |
France | Assistance Publique - Hôpitaux de Paris - Hôpital COCHIN | Paris | ILE DE France |
France | Service d'Hypertension et de Médecine Vasculaire - Assistance Publique - Hôpitaux de Paris - Hôpital européen Georges Pompidou | Paris | ILE DE France |
France | Service Endocrinologie, Diabétologie, maladies métaboliques - CHU de Bordeaux | Pessac | Aquitaine |
France | CHU de Poitiers | Poitiers | |
France | Endocrinologie, Diabète et Maladies Métaboliques - CHU de Rouen | Rouen | Haute-Normandie |
France | Service de Médecine Interne, Endocrinologie et Nutrition - CHU de Strasbourg | Strasbourg | Alsace |
France | Service d'Endocrinologie et Maladies Métabolique - CHU de Toulouse | Toulouse | Midi-Pyrénées |
Germany | Endokrinologie, Diabetes und Ernährungsmedizin, Campus Mitte, Medizinische Klinik - Charité - Universitätsmedizin Berlin | Berlin | |
Germany | Department of Internal Medicine I, Endocrine and Diabetes Uni -University Hospital Würzburg | Würzburg | |
Italy | S Orsola-Malpighi Hospital | Bologna |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Bordeaux |
France, Germany, Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Antihypertensive treatment score and daily drug dose | 12 months | ||
Secondary | Incidence of complications in the two strategies. | 12 months | ||
Secondary | Direct costs of the two strategies. | 12 months | ||
Secondary | Assessment of predictive factors for the success of surgery on BP | age, family history of hypertension, duration of hypertension, kidney function, biochemical endocrine abnormalities, urinary steroid profile | 12 months | |
Secondary | number of patients requiring antihypertensive treatment | 12 months | ||
Secondary | 24 hours ambulatory blood pressure monitoring values | At inclusion (day 0) and at 12 months | ||
Secondary | Blood glucose and lipid lowering agents values | 12 months | ||
Secondary | Cardiovascular risk factors/markers level | Comparison of the two therapeutic strategies with regard to cardiovascular risk factors/markers: BMI, body composition evaluated by DEXA, abdominal fat evaluated on CT-scan, fasting blood glucose and insulin, HbA1C, HOMA-IR (homeostasis model of assessment of insulin resistance) and OGTT (oral glucose tolerance test), blood lipids, pro-inflammatory adipokines | 12 months | |
Secondary | Number of patients with persistent diabetes, dyslipidemia and metabolic syndrome | 12 months | ||
Secondary | Evaluation of quality of life | Comparison of the two therapeutic strategies with regard to quality of life | At inclusion and 12 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
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