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NCT Number: NCT05082311

Cardiac and Vascular Changes in Pheochromocytoma and Paraganglioma

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

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Key information

Conditions

Pheochromocytoma Cardiomyopathies Cardiovascular Diseases Cardiovascular Morbidity Heart Diseases Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Paraganglioma

Age range

7 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sanjay Gandhi Postgraduate Institute of Medical Sciences

Lucknow, Uttar Pradesh, 226014, India

About this study

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

This prospective, case-control study is conducted at SGPGIMS, Lucknow, India, tertiary care referral institute, between January 2019 and September 2021 after approval from institutional ethics committee. The study group includes 50 biochemically and histopathology proven PCC /Paraganglioma patients, who after 1 to 3 weeks of α-adrenoceptor blockade with oral prazosin undergo primary laparoscopic or open surgery. Cure of hypercatecholaminism will be documented by normal 24-hour urinary fractionated metanephrine values at 7-10 days postoperatively.

Two contemporary age- and gender-matched control groups includes 10 newly detected (withtin 3 months) Essential Hypertensive (E-HT) patients, who will undergo treatment with standard anti- HT medications and 10 Healthy individuals (normal in physical examination, ECG , Echo), that include hospital staff nurses, technicians, doctors whom would be requested to volunteer.

METHODOLOGY

Patients in the study group, besides the usual evaluation of PCC, also undergo detailed cardiac and vascular evaluation, at diagnosis, at 7- 10 days of α-blockade, and 7 days, 3 and 6 months post adrenalectomy/ Paraganglioma excision and in control groups - E-HT controls, cardiac evaluation is done at diagnosis and after 3 months of anti HT medications ; in Healthy individuals, cardiac evaluation is done at the start of study and after 6 months.

The CV evaluation includes 2D-echocardiography, speckle tracking Echo (for measuring global longitudinal strain), serum NT-proBNP estimation and flow mediated vasodilatory studies by Doppler Ultrasonography of the brachial artery to assess the endothelial dependent and smooth muscle dependent vasodilatory responses

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients diagnosed of Pheochromocytoma (PCC) / Paraganglioma (secretory, extra adrenal PCC) Patients willing to consent for the study Patients not on α-blockade at the time of recruitment into study, can be on any other anti hypertensives

Exclusion criteria

  • Non-secretory Paraganglioma Patients who refuse consent, not compliant in follow up Patients who are on α- blockade already Essential Hypertensives with compounding comorbidities that could interfere with cardio vascular evaluation

Treatment and study plan

observational study

Other

This is an observational study

Primary outcomes

  1. Change of Systolic function indices measurement by 2D-Echocardiography from Baseline versus after alpha blockade and after surgery

    Time frame: at baseline (Day 1), at Day 7- 10 after initiation of α-blockade, and 7 days, 3 and 6 months post adrenalectomy/ Paraganglioma excision

    Left ventricle end systolic and end diastolic diameter in millimeter

  2. Change of Systolic function indices measurement by 2D-Echocardiography from baseline versus after alpha blockade and after surgery

    Time frame: at baseline (day 1), at Day 7- 10 after initiation of α-blockade, and 7 days, 3 and 6 months post adrenalectomy/ Paraganglioma excision

    Left ventricle end systolic and end diastolic volume dimensions in milliliter

  3. Change of Systolic function index measurement by 2D-Echocardiography from Baseline at after alpha blockade and at after surgery

    Time frame: at baseline (Day1), at Day 7- 10 after initiation of α-blockade, and 7 days, 3 and 6 months post adrenalectomy/ Paraganglioma excision

    Left ventricle Ejection fraction by Simpsons method in percentage

  4. Change of Diastolic function index measurement by pulsed wave doppler echocardiography from baseline versus after alpha blockade and after surgery

    Time frame: at baseline (Day 1), at Day 7- 10 after initiation of α-blockade, and 7 days, 3 and 6 months after adrenalectomy/ Paraganglioma excision

    Peak velocities of the early (E) and Late phase (A) of the mitral valve inflow pattern and their ratio in centimeter per second

  5. Change of Diastolic function indices measurement by pulsed wave doppler echocardiography from baseline versus after alpha blockade and after surgery

    Time frame: at baseline (day 1), at day 7- 10 after initiation of α-blockade, and 7 days, 3 and 6 months after adrenalectomy/ Paraganglioma excision

    Flow rate across mitral valve in centimeter per second and deceleration time in millisecond

  6. Change in Speckle tracking echocardiographic parameters at Baseline versus after alpha blockade and at after surgery

    Time frame: at baseline (Day 1), at Day 7- 10 after initiation of α-blockade, and 7 days, 3 and 6 months post adrenalectomy/ Paraganglioma excision

    Left ventricle global longitudinal strain in percentage

  7. Change in Speckle tracking echocardiographic parameters from Baseline in comparison to after alpha blockade and after surgery

    Time frame: at baseline (Day 1), at Day 7- 10 after initiation of α-blockade, and 7 days, 3 and 6 months post surgery

    Left ventricle global circumferential strain in percentage

  8. Change in Vascular Function indices by doppler Ultrasonography of the brachial artery from baseline at after alpha blockade and at after surgery

    Time frame: at baseline (Day 1), at Day 7- 10 after initiation of α-blockade, and 7 days, 3 and 6 months post adrenalectomy/ Paraganglioma excision

    Flow mediated dilation of brachial artery diameter pre and post sublingual isosorbide dinitrate in millimeter

Sponsors and collaborators

Lead sponsor

Sanjay Gandhi Postgraduate Institute of Medical Sciences

Other Gov

Registry information

Official study title

Prospective Cohort Study of Objective Cardiac and Vascular Changes in Pheochromocytoma and Paraganglioma and Their Reversal Following Curative Surgery

Acronym: PheoCard

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Oct 18, 2021
Registry last updated
Feb 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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