Clinical trial · Observational
Multicenter Study on Cardiovascular and Metabolic Complications in Patients With Biochemically Silent Pheochromocytomas and Paragangliomas
NCT07316075CI-TRIAL-00100098enrolling by invitationClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Arterial Blood Pressure | — | UNRESOLVED | — |
| Cardiovascular Abnormalities | — | UNRESOLVED | — |
| Cerebrovascular Disease | — | UNRESOLVED | — |
| Congestive Heart Failure Chronic | — | UNRESOLVED | — |
| Coronary Syndrome | — | UNRESOLVED | — |
| Diabete Mellitus | — | UNRESOLVED | — |
| Heart Rate | — | UNRESOLVED | — |
| Hyperlipidaemia | — | UNRESOLVED | — |
| Myocarditis, Pericarditis | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (3)
- label
- Patients with biochemically silent PPGLs
- description
- Patients with non-detectable levels of metanephrines/normetanephrines in the blood or in the urine via LC-MS.
- label
- Controls ( healthy individuals)
- description
- Healthy individuals with normal adrenal gland
- label
- Patients with secreting PPGLs
- description
- Patients with measurable levels of metanephrines or normetanephrines in the blood or urine ( \> 2-fold) via LC-MS
Primary outcomes (6)
- measure
- 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
- description
- Mean Systolic and diastolic BP (x3) in mmHg before and after any therapeutic intervention or follow-up
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (5)
- BACKGROUNDZhou 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
- BACKGROUNDKumar 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
- BACKGROUNDSzatko 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
- BACKGROUNDY-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
- BACKGROUNDConstantinescu 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