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Enrolling by invitationNCT07316075Updated Jan 5, 2026

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

An observational study in Cardiovascular Abnormalities, Arterial Blood Pressure and Heart Rate, sponsored by Laikο General Hospital, Athens. Enrolling by invitation at 1 site in Greece. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-05.

Sponsored by Laikο General Hospital, Athens · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
50
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • 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
03

In context

Cardiovascular Abnormalities

64 studies on the registry are indexed under Cardiovascular Abnormalities; 15 are open to participants now.

This study's planned enrollment of 50 is below the median of 100 across 25 observational studies indexed under Cardiovascular Abnormalities.

Browse Cardiovascular Abnormalities studies →

Lead sponsor

Laikο General Hospital, Athens is the lead sponsor of 8 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. 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

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

  2. 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

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

  3. 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

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

  4. 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

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

  5. 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

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

  6. 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

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

Secondary outcomes

  1. Changes in the levels of blood Hb1Ac before and after any therapeutic intervention

    Measurement of Hb1AC % in the blood

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

  2. Changes in the concentrations of cholesterol, LDL and HDL in the blood before and after any intervention

    Measurement of blood cholesterol in mg/dl, HDL in mg/dl and LDL in mg/dl before and after any therapeutic intervention

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

Other outcomes

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

    Triplex of carotides with measurement in mm of Intima-Media Thickness and of Atheromatous Plaque (appearance, surface)before and after any intervention

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

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

    Mesurement of proBNP at blood analysis (pg/ml)

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

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

    Measurement of troponine levels (ng/ml) in the blood

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

07

Study locations

1 site
  • NKUA
    Athens, Greece
08

References and documents

Publications

  • 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. PubMed 33882857 ↗
  • 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. PubMed 34957765 ↗
  • 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. PubMed 37522121 ↗
  • 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. PubMed 32751501 ↗
  • 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. PubMed 36325453 ↗

Individual participant data

Plan to share: Undecided — Personal protection data

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07316075
Lead sponsor
Laikο General Hospital, Athens
Responsible party
Anna Angelousi (Associate Professor, Laikο General Hospital, Athens) — Principal investigator
First posted
Jan 5, 2026
Start date
Feb 5, 2024
Primary completion
Dec 1, 2024
Completion
Feb 25, 2027 (estimated)
Last update
Jan 5, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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