Cardiovascular AbnormalitiesNCT07316075
Multicenter Study on Cardiovascular and Metabolic Complications in Patients With Biochemically Silent Pheochromocytomas and Paragangliomas
An observational study of Cardiovascular Abnormalities and Arterial Blood Pressure, run by Laikο General Hospital, Athens at 1 site in Greece.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Abnormalities, Arterial Blood Pressure, Heart Rate
- How many people
- 50 participants
- Where
- 1 siteGreece
- Study dates
- 5 Feb 2024to 25 Feb 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Any adult patient with a confirmed histopathological or imaging diagnosis of PPGL (biochemical silent vs secreting)
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
- Conditions
- Cardiovascular Abnormalities, Arterial Blood Pressure, Heart Rate, Congestive Heart Failure Chronic, Coronary Syndrome, Cerebrovascular Disease
- Keywords
- pheochromocytoma, paraganglioma, cardiovascular risk, cerebrovascular risk, blood pressure, coronary syndrome, heart rate, metabiolic syndrome, hypelipidemia, diabetes
- Medical subject headings
- Cardiovascular Abnormalities, Angina, Unstable, Cerebrovascular Disorders, Myocarditis, Pericarditis, Hyperlipidemias, Diabetes Mellitus, Pheochromocytoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measurement of Hb1AC % in the blood
Measured: 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
Measurement of blood cholesterol in mg/dl, HDL in mg/dl and LDL in mg/dl before and after any therapeutic intervention
Measured: Baseline at diagnosis and 6 months post any intervention or follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2026
- Study start5 Feb 2024
- Primary completion1 Dec 2024
- Study completion25 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular AbnormalitiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laikο General Hospital, Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Angelousi, Laikο General Hospital, Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07316075
- Sponsor's protocol ID
- 2240/12.02.2025
- Status last verified
- Dec 2025
- First submitted
- 7 Dec 2025
- Last updated
- 5 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Personal protection data
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 33882857Kumar 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 34957765Szatko 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 37522121Y-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 32751501Constantinescu 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