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

NCT07316075 | Enrolling By Invitation

• 1 other identifier: 2240/12.02.2025
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Abnormalities; Arterial Blood Pressure; Heart Rate; Congestive Heart Failure Chronic; Coronary Syndrome; Cerebrovascular Disease; Myocarditis, Pericarditis; Hyperlipidaemia; Diabete Mellitus

Keywords

pheochromocytoma; paraganglioma; cardiovascular risk; cerebrovascular risk; blood pressure; coronary syndrome; heart rate; metabiolic syndrome; hypelipidemia; diabetes

Outcome Measures

Primary Outcomes (6)

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

  Mean Systolic and diastolic BP (x3) in mmHg before and after any therapeutic intervention or follow-up

  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

  Mean heart rate before and after any therapeutic intervention or follow-up

  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

  Echocardiogram and estimation of fraction of ejection before and after any treatment or follow-up

  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

  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

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

• Incidence of cerebrovascular event permanent or transient

  Incidence of cerebrovascular disease, permanent or transient, and evaluation with cerebral MRI before and after any therapeutic intervention

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

• Incidence of myocarditis before and after any therapeutic intervention

  episode of myocarditis based on increased troponine, cardiac MRI and heart triplex before and after any intervention

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

Secondary Outcomes (2)

• 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

Other Outcomes (3)

• Changes of the Intima-Media Thickness and of Atheromatous Plaque before and after any intervention

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

• Changes of proBNP levels in the blood before and after any intervention

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

• Changes in troponine levels in the blood before and after any therapeutic intervention

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

Study Arms (3)

Patients with biochemically silent PPGLs

Patients with non-detectable levels of metanephrines/normetanephrines in the blood or in the urine via LC-MS.

Controls ( healthy individuals)

Healthy individuals with normal adrenal gland

Patients with secreting PPGLs

Patients with measurable levels of metanephrines or normetanephrines in the blood or urine ( \> 2-fold) via LC-MS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Any adult patient with a confirmed histopathological or imaging diagnosis of PPGL (biochemical silent vs secreting)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Laikο General Hospital, Athens: lead

Study Sites (1)

NKUA

Athens, Greece

Location

Related Publications (5)

• Zhou J, Xuan H, Miao Y, Hu J, Dai Y. Acute cardiac complications and subclinical myocardial injuries associated with pheochromocytoma and paraganglioma. BMC Cardiovasc Disord. 2021 Apr 21;21(1):203. doi: 10.1186/s12872-021-02013-6.

  PMID: 33882857 BACKGROUND

• Kumar A, Pappachan JM, Fernandez CJ. Catecholamine-induced cardiomyopathy: an endocrinologist's perspective. Rev Cardiovasc Med. 2021 Dec 22;22(4):1215-1228. doi: 10.31083/j.rcm2204130.

  PMID: 34957765 BACKGROUND

• Szatko A, Glinicki P, Gietka-Czernel M. Pheochromocytoma/paraganglioma-associated cardiomyopathy. Front Endocrinol (Lausanne). 2023 Jul 13;14:1204851. doi: 10.3389/fendo.2023.1204851. eCollection 2023.

  PMID: 37522121 BACKGROUND

• Y-Hassan S, Falhammar H. Cardiovascular Manifestations and Complications of Pheochromocytomas and Paragangliomas. J Clin Med. 2020 Jul 30;9(8):2435. doi: 10.3390/jcm9082435.

  PMID: 32751501 BACKGROUND

• Constantinescu G, Preda C, Constantinescu V, Siepmann T, Bornstein SR, Lenders JWM, Eisenhofer G, Pamporaki C. Silent pheochromocytoma and paraganglioma: Systematic review and proposed definitions for standardized terminology. Front Endocrinol (Lausanne). 2022 Oct 17;13:1021420. doi: 10.3389/fendo.2022.1021420. eCollection 2022.

  PMID: 36325453 BACKGROUND

MeSH Terms

Conditions

Cardiovascular Abnormalities; Angina, Unstable; Cerebrovascular Disorders; Myocarditis; Pericarditis; Hyperlipidemias; Diabetes Mellitus; Pheochromocytoma; Paraganglioma

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Angina Pectoris; Myocardial Ischemia; Heart Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cardiomyopathies; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Glucose Metabolism Disorders; Endocrine System Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 7, 2025
• First Posted: January 5, 2026
• Study Start: February 5, 2024
• Primary Completion: December 1, 2024
• Study Completion (Estimated): February 25, 2027
• Last Updated: January 5, 2026

Record last verified: 2025-12

Locations

GR (1)