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
An erratum to this article was published (Lancet Diabetes Endocrinol, Aug 2025 ↗)
Primary result · Reduction in antihypertensive treatment with normal HBPMResult — go to the resultAdjusted risk difference 0.34 95% CI 0.11–0.58Authors' conclusion
MACS associated with unilateral adrenal incidentalomas is responsible for secondary hypertension that can be safely improved by minimally-invasive adrenalectomy.
Study context
- Population
- Adults with hypertension and mild autonomous cortisol secretion (MACS) with unilateral adrenal incidentalomas, after run-in confirming hypertension by home blood pressure measurements (HBPM) and BP normalised with standardised stepped-care antihypertensive treatment; 17 university hospitals in France, Italy and Germany; median age 63.3 years, 69% femalerandomly assigned
- Participants
- 52 adults
- Comparison
- Adrenalectomy vs conservative management
- Adrenalectomyn = 26
- Conservative managementn = 26reference
- Primary endpoint
- Proportion of normotensive participants by HBPM who reduced antihypertensive treatment, ITT population
- Follow-up
- Study completion (13 months)
Methodological detailsmulticentre, superiority, open-label, parallel, stratified block randomisation, Enrolled April 9, 2015 to Nov 23, 2022; 78 enrolled, 23 underwent adrenalectomy and completed; 25 completed conservative management
- Multicentre
- Superiority
- Open-label
- Parallel
- Stratified block randomisation
- Enrolled April 9, 2015 to Nov 23, 2022; 78 enrolled
- 23 underwent adrenalectomy and completed; 25 completed conservative management
Primary result
As reported in the abstract
Reduction in antihypertensive treatment with normal HBPM · study completion
Adjusted risk difference
0.34
95% CI 0.11–0.58
P = 0.0038
Events by treatment group
Adrenalectomyvs Conservative management
adjusted risk difference 0.34 (95% CI 0.11–0.58); P = 0.0038
Secondary outcomes
| Outcome | Adrenalectomy | Conservative management | Estimate | P value | |
|---|---|---|---|---|---|
| Still needing antihypertensive treatment · study completion | 43% | 96% | adjusted RD −0.58 (95% CI −0.78 to −0.38) | P < 0.0001 | |
| Antihypertensive treatment step · study completionMean | 0.8 (SD 1.1) | 3.0 (SD 1.4) | adjusted difference −2.05 (95% CI −2.61 to −1.50) | P < 0.0001 | |
| −4−202Difference (linear scale) |
| Outcome | Adrenalectomy | Conservative management |
|---|---|---|
| Normal systolic HBPM and no antihypertensive treatment · study completion | 52% | 0 events |
- Still needing antihypertensive treatment: of 23 and 25 participants
- Normal systolic HBPM and no antihypertensive treatment: Adrenalectomy: of 23
Systolic BP on 24 h ambulatory blood pressure measurement (ABPM)
- Similar results of smaller magnitude
Safety
Serious adverse events
- Serious adverse events — Surgery-related serious adverse events (post-surgical wall pain and hypotension)
- 3 events in 3 (13%) participants
- Serious adverse events: of 23 and 26 participants
Original publication
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. Published 12 May 2025. doi:10.
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