A Proof-of-Concept Study Evaluating the Safety and Efficacy of Bilateral Partial Adrenalectomy in Patients with Bilateral Primary Aldosteronism

A Proof-of-Concept Study Evaluating the Safety and Efficacy of Bilateral Partial Adrenalectomy in Patients with Bilateral Primary Aldosteronism - BALANCE

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00037790

Enrollment

Registered

2025-11-05

Start date

2026-05-01

Completion date

Unknown

Last updated

2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

E26.0

Interventions

Group 1: Bilateral partial adrenalectomy (“adrenal debulking”): laparoscopic surgery removing the hyperfunctioning tissue while preserving =33% of total adrenal volume (bilateral partial or unilateral

follow-up up to 12 months.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Confirmed bilateral primary aldosteronism according to Endocrine Society guidelines Nodular adrenal morphology on CT or MRI imaging Willingness to undergo surgical intervention Written informed consent Cohort I: Resistant hypertension under maximum tolerable medical therapy including a mineralocorticoid receptor antagonist (MRA) or persistent hypokalemia High cardiovascular comorbidity burden, defined as at least one major adverse cardiac event (MACE) or two cardiovascular risk factors ((pre-)diabetes, hyperlipidemia, renal impairment) Significantly impaired quality of life Cohort II: Severe resistant hypertension under maximum tolerable medical therapy including an MRA, or persistent hypokalemia, or intolerance to standard MRA treatment Significantly impaired quality of life Cohort III: Preference for surgical intervention over long-term medical MRA therapy

Exclusion criteria

Exclusion criteria: Confirmed diagnosis of unilateral PA based on current Endocrine Society guidelines Normal appearing adrenals on CT or MRI Pregnancy Severe renal impairment (eGFR < 30 mL/min/1.73m2) Active malignancy Contraindications to surgery or general anesthesia Inability to give informed written consent

Design outcomes

Primary

Measure	Time frame
Safety: 30-day postoperative morbidity and mortality (including bleeding, infection, organ injury, hemodynamic complications, adrenal insufficiency).	—

Secondary

Measure	Time frame
Blood pressure control, biochemical remission, quality of life, MACE, adrenal function, overall mortality	—

Countries

Germany

Contacts

Public ContactMatthias Oettle

LMU Klinikum

matthias.oettle@med.uni-muenchen.de+4989440052317

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 11, 2026