PET scan with [68Ga]Ga-PentixaFor compared to adrenal vein sampling in a research to compare hypertension outcomes in patients with primary aldosteronism

Phase 1

• Conditions: Primary Aldosteronism; MedDRA version: 20.1Level: PTClassification code 10036692Term: Primary hyperaldosteronismSystem Organ Class: 10014698 - Endocrine disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2021-003460-27-NL
• Lead Sponsor: Radboudumc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-12-17
• Last Update Posted: 10 January 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 281

Inclusion Criteria

- The patient has a diagnosis of primary aldosteronism, confirmed by an elevated aldosterone/rennin ratio (ARR) and an intravenous salt-loading test (according to the Endocrine Society guidelines)(1)
- Age over 18 years at time of consent
- Signed informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 281
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 281

Exclusion Criteria

- Refusal by the patients to undergo AVS, [68Ga]Ga-PentixaFor PET/CT, CT, or adrenalectomy
- Suspicion of familial hyperaldosteronism type 1 (FH-1) or type 3 (FH-3)
- Suspicion of adrenocortical carcinoma
- Severe comorbidity potentially interfering with treatment or health-related quality of life
- Requirement of medication interfering with the study protocol
- Any medical condition present that in the opinion of the investigator will affect patients’ clinical status.
- Pregnancy or lactation
•Estimated glomerular filtration rate (eGFR) < 40 ml/min/1.73m²

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified