NCT05082311: PheoCard

Cardiac and Vascular Changes in Pheochromocytoma and Paraganglioma

Completed Last updated 10 February 2022

What this trial tests

trial testing Observational study in Pheochromocytoma in 55 participants. Completed in 31 January 2022.

Timeline

19 January 2019

Primary endpoint
30 November 2021

31 January 2022

Quick facts

Lead sponsor	Sanjay Gandhi Postgraduate Institute of Medical Sciences
Status	Completed
Study type	OBSERVATIONAL
Enrollment	55
Start date	19 January 2019
Primary completion	30 November 2021
Estimated completion	31 January 2022
Sites	1 location across India

Drugs / interventions tested

• Observational study — full drug profile →

Conditions studied

• Pheochromocytoma — all drugs for Pheochromocytoma →
• Paraganglioma — all drugs for Paraganglioma →
• Cardiovascular Morbidity — all drugs for Cardiovascular Morbidity →

Sponsor

Sanjay Gandhi Postgraduate Institute of Medical Sciences

Who can join

7 and older, any sex, with Pheochromocytoma or Paraganglioma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

PHEOCHROMOCYTOMA (PCC)/ PARAGANGLIOMA are catecholamine secreting tumors with varied manifestations. Besides hypertension, PCC patients may have subclinical to overt cardiac and vascular dysfunction, which are important to recognize to minimize perioperative morbidity and mortality. Cardiovascular (CV) dysfunction can be in the form of hypertension, left ventricular (LV) hypertrophy, heart failure, cardiomyopathy, dysrhythmias, angina and Myocardial infarction. Literature search revealed a few retrospective and a few prospective studies, including one prospective follow up study conducted at SGPGIMS to document CV changes in PCC. Our institutional study was the first to document the nature and extent of CV dysfunction and cardiomyopathy and their reversal after surgical cure. The studies revealed that PCC patients had significantly higher LV mass index, higher LV diastolic dysfunction, subclinical impaired LV systolic function. Earlier studies postulated apparent improvement in various cardiac indices even with selective α-blockade and continued after surgical cure, with near normalization at 3 -6 months postoperatively. Detailed cardiac and vascular evaluation in PCC patients can be of help in preoperative optimization of cardiac risk and may provide prognostic information The literature on PCC-mediated CV dysfunction and catecholamine cardiomyopathy is largely limited to case reports and retrospective studies, with few reports of their reversal after curative PCC operations. Whether the duration of disease influence the function of heart was not apparently addressed in earlier trials. Trials that established the differences in the degree of cardiac dysfunction between normotensive and hypertensive PCC patients involved smaller proportion of study subjects. Sub clinical changes in endomyocardium was presumed but not objectively assessed and hence its reversal after surgical cure is uncertain.

The aim of this research is to study the cardiac and vascular changes in Pheochromocytoma/ Paraganglioma patients and their reversal following curative surgery

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Cardiac Changes and Their Reversal Following Curative Surgery in Pheochromocytoma: PheoCard Prospective Cohort Study.
   Vishvak Chanthar KMM, Khanna R, Agarwal G, Rout SR, et al · · 2023 · cited 5× · PMID 36210362 · DOI 10.1007/s00268-022-06731-6