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Surgery of Subclinical Cortisol Secreting Adrenal Incidentalomas

NCT02364089 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2023-07-20

No results posted yet for this study

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.

Conditions

  • Adrenal Incidentalomas

Interventions

PROCEDURE

Laparoscopic surgical removal of the adrenal tumor

DRUG

Standardized medical treatment of hypertension by SAHR

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.

Sponsors & Collaborators

  • University Hospital, Bordeaux

    lead OTHER

Principal Investigators

  • Eric FRISON, Dr · University Hospital, Bordeaux

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-09
Primary Completion
2022-03-09
Completion
2022-11-23

Countries

  • France
  • Germany
  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02364089 on ClinicalTrials.gov