Multicenter Study on Cardiovascular and Metabolic Complications in Patients With Biochemically Silent Pheochromocytomas and Paragangliomas
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Changes in arterial blood pressure (BP) in mmHg before and after any therapeutic intervention
Study Overview
Brief 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
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Changes in arterial blood pressure (BP) in mmHg before and after any therapeutic intervention
Time Frame: Baseline at diagnosis and 6 months post any intervention or follow-up
Mean Systolic and diastolic BP (x3) in mmHg before and after any therapeutic intervention or follow-up
Changes in the heart rate (pulsation/min) before and after any therapeutic intervention or follow-up
Time Frame: Baseline at diagnosis and 6 months post any intervention or follow-up
Mean heart rate before and after any therapeutic intervention or follow-up
Changes in the fraction of ejection of the heart estimated by cardiac triplex before and after any treatment
Time Frame: Baseline at diagnosis and 6 months post any intervention or follow-up
Echocardiogram and estimation of fraction of ejection before and after any treatment or follow-up
Incidence (number) and characterisation of coronary syndrome (angina, cardiac infarction) before and after any intervention or follow-up
Time Frame: Baseline at diagnosis and 6 months post any intervention or follow-up
Incidence of an episode of coronary syndrome, like angina or cardiac infarction and evaluation of the electrocardiogram (changes of ST waves or Q waves or Left blovk branch) and signs of ventricule hypokinesia or akinesia in the heart triplex before and after any treatment or follow-up
Incidence of cerebrovascular event permanent or transient
Time Frame: Baseline at diagnosis and 6 months post any intervention or follow-up
Incidence of cerebrovascular disease, permanent or transient, and evaluation with cerebral MRI before and after any therapeutic intervention
Incidence of myocarditis before and after any therapeutic intervention
Time Frame: Baseline at diagnosis and 6 months post any intervention or follow-up
episode of myocarditis based on increased troponine, cardiac MRI and heart triplex before and after any intervention
Secondary Outcomes
- Changes in the levels of blood Hb1Ac before and after any therapeutic intervention(Baseline at diagnosis and 6 months post any intervention or follow-up)
- Changes in the concentrations of cholesterol, LDL and HDL in the blood before and after any intervention(Baseline at diagnosis and 6 months post any intervention or follow-up)
Investigators
Anna Angelousi
Associate Professor
Laikο General Hospital, Athens