By InvitationNot Applicable

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

Greece50 participantsStarted 2024-02-05

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * All PHEOs/PGLs patients should be asymptomatic, with confirmed histopathological analysis for those who had surgery or with positive specific imaging functional studies (MIBG, 68Ga DOTATATE, Octreoscan, Tektrotyde) * Data about the plasma or urine levels of catecholamines, normetanephrines, metanephrines and methoxytyramine (for PGL) levels should be available for every patient and should be lower than the upper normal values measured with LC-MS (supplementary data about CgA, NSE levels can be also included) * Available data for the "required" cardiovascular paraclinical or metabolic parameters should be available pre-surgery or at the time of diagnosis or at follow-up for the "not operable" tumors as well as post any treatment Exclusion Criteria: * Patients with ambiguous diagnosis of PHEOs/PGLs (absence of histological report and non-specific imaging findings) * Catecholamines, normetanephrines and metanephrines (and methoxytyramine levels for PGL) levels higher than the upper limit range * No available data of the required parameters

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Changes in arterial blood pressure (BP) in mmHg before and after any therapeutic intervention

Timeframe: Baseline at diagnosis and 6 months post any intervention or follow-up

Changes in the heart rate (pulsation/min) before and after any therapeutic intervention or follow-up

Timeframe: Baseline at diagnosis and 6 months post any intervention or follow-up

Changes in the fraction of ejection of the heart estimated by cardiac triplex before and after any treatment

Timeframe: Baseline at diagnosis and 6 months post any intervention or follow-up

Incidence (number) and characterisation of coronary syndrome (angina, cardiac infarction) before and after any intervention or follow-up

Timeframe: Baseline at diagnosis and 6 months post any intervention or follow-up

Incidence of cerebrovascular event permanent or transient

Timeframe: Baseline at diagnosis and 6 months post any intervention or follow-up

Incidence of myocarditis before and after any therapeutic intervention

Timeframe: Baseline at diagnosis and 6 months post any intervention or follow-up

Trial details

NCT IDNCT07316075

SponsorLaikο General Hospital, Athens

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-12-01

View on ClinicalTrials.gov More Cardiovascular Abnormalities trials