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Enrolling By InvitationNCT07316075

Multicenter Study on Cardiovascular and Metabolic Complications in Patients With Biochemically Silent Pheochromocytomas and Paragangliomas

Status
Enrolling By Invitation
Phase
Study type
Observational
Enrollment
50 (estimated)
Sponsor
Laikο General Hospital, Athens · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

Summary

The aim of the study is to characterise the cardiovascular and metabolic complications pre- and post-surgery of patients with biochemically negative PPGL and to compare them with normal individuals and patients with secreting PPGLs age and sex matched.

Detailed description

Pheochromocytomas (PHEO) and Paragangliomas (PGL) represent a group of tumors associated with increased cardiometabolic morbidities and mortality. The secretory components of PHEOs/PGLs are well-established risk factors for cardiovascular events and the Endocrine Society Clinical Practice Guidelines have implemented specific instructions for their management and their follow-up. However, data regarding the cardiovascular risk in PHEOs and PGLs asymptomatic patients with the normal biochemical profile are sparse and debating. The incidence of cardiovascular complications and the long-term morbidity in this group of patients is not well-characterized complicating the therapeutic approach or the necessity of pre-operative a-blockade as well as the optimal follow-up, regarding the duration and the need for cardiovascular examination. Aim Primary outcome v To characterize the cardiovascular and metabolic complications of patients with biochemically negative PPGLs and to compare them with individuals age and sex-matched with normal adrenals (controls) as well as with patients with secreting PHEOs/PGLs. Secondary outcome v To study also the sub-mentioned parameters post-treatment

Conditions

Timeline

Start date
2024-02-05
Primary completion
2024-12-01
Completion
2027-02-25
First posted
2026-01-05
Last updated
2026-01-05

Locations

1 site across 1 country: Greece

Source: ClinicalTrials.gov record NCT07316075. Inclusion in this directory is not an endorsement.