PheochromocytomaPheoCardNCT05082311
Cardiac and Vascular Changes in Pheochromocytoma and Paraganglioma
An observational study of Pheochromocytoma and Paraganglioma, run by Sanjay Gandhi Postgraduate Institute of Medical Sciences at 1 site in India.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 7 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pheochromocytoma, Paraganglioma, Cardiovascular Morbidity
- What is being tested?
- Observational study
- How many people
- 55 participants
- Where
- 1 siteIndia
- Study dates
- 19 Jan 2019to 31 Jan 2022
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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 7 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study group will include 50 biochemically and histopathology proven Pheochromocytoma /Paraganglioma patients, who after 1 to 3 weeks of α-adrenoceptor blockade with oral prazosin will 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
India1 site
Sanjay Gandhi Postgraduate Institute of Medical Sciences
Lucknow, Uttar Pradesh, 226014
About this study
Official title: Prospective Cohort Study of Objective Cardiac and Vascular Changes in Pheochromocytoma and Paraganglioma and Their Reversal Following Curative Surgery
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
Read the detailed description
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
- Conditions
- Pheochromocytoma, Paraganglioma, Cardiovascular Morbidity
- Being tested
- Observational study
- Keywords
- Pheochromocytoma, Paraganglioma, Cardio vascular manifestations, Cardiomyopathy, Speckle Tracking echocardiography
- Medical subject headings
- Pheochromocytoma, Paraganglioma, Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational studyOther
This is an observational study
| Study group | Role | What they receive |
|---|---|---|
| Patients with Pheochromocytoma/Paraganglioma (secretory, extra adrenal pheochromocytoma) | Patients included in this cohort (n=50) are those who are diagnosed of Pheochromocytoma / Paraganglioma, willing to consent for the study and not on α-blockade at the time of recruitment into study, while can be on any other anti hypertensives
Patients in this group, besides the usual evaluation of Pheochromocytoma / Paraganglioma, will also undergo detailed cardiac and vascular evaluation, which will be done at diagnosis, at 7- 10 days of α-blockade, and 7 days, 3 and 6 months post adrenalectomy/ Paraganglioma excision The cardiovascular 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 Receives: Other: Observational study | |
| Essential Hypertensive Groups | This is a contemporary age- and gender-matched control group This group includes 10 newly detected (within 3 months) Essential Hypertensive patients, who will undergo treatment with standard anti- HT medications Cardiac evaluation will be done at baseline and after 3 months of anti hypertensive medications Receives: Other: Observational study | |
| Healthy Individuals | This is a contemporary age- and gender-matched control group This group includes 10 Healthy individuals (normal in physical examination, ECG , Echo), that include hospital staff nurses, technicians, doctors whom would be requested to volunteer Cardiac evaluation will be done at the start of study and after 6 months Receives: Other: Observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Systolic function indices measurement by 2D-Echocardiography from Baseline versus after alpha blockade and after surgery
Left ventricle end systolic and end diastolic diameter in millimeter
Measured: at baseline (Day 1), at Day 7- 10 after initiation of α-blockade, and 7 days, 3 and 6 months post adrenalectomy/ Paraganglioma excision
Change of Systolic function indices measurement by 2D-Echocardiography from baseline versus after alpha blockade and after surgery
Left ventricle end systolic and end diastolic volume dimensions in milliliter
Measured: at baseline (day 1), at Day 7- 10 after initiation of α-blockade, and 7 days, 3 and 6 months post adrenalectomy/ Paraganglioma excision
Change of Systolic function index measurement by 2D-Echocardiography from Baseline at after alpha blockade and at after surgery
Left ventricle Ejection fraction by Simpsons method in percentage
Measured: at baseline (Day1), at Day 7- 10 after initiation of α-blockade, and 7 days, 3 and 6 months post adrenalectomy/ Paraganglioma excision
Change of Diastolic function index measurement by pulsed wave doppler echocardiography from baseline versus after alpha blockade and after surgery
Peak velocities of the early (E) and Late phase (A) of the mitral valve inflow pattern and their ratio in centimeter per second
Measured: at baseline (Day 1), at Day 7- 10 after initiation of α-blockade, and 7 days, 3 and 6 months after adrenalectomy/ Paraganglioma excision
Change of Diastolic function indices measurement by pulsed wave doppler echocardiography from baseline versus after alpha blockade and after surgery
Flow rate across mitral valve in centimeter per second and deceleration time in millisecond
Measured: at baseline (day 1), at day 7- 10 after initiation of α-blockade, and 7 days, 3 and 6 months after adrenalectomy/ Paraganglioma excision
Change in Speckle tracking echocardiographic parameters at Baseline versus after alpha blockade and at after surgery
Left ventricle global longitudinal strain in percentage
Measured: at baseline (Day 1), at Day 7- 10 after initiation of α-blockade, and 7 days, 3 and 6 months post adrenalectomy/ Paraganglioma excision
Change in Speckle tracking echocardiographic parameters from Baseline in comparison to after alpha blockade and after surgery
Left ventricle global circumferential strain in percentage
Measured: at baseline (Day 1), at Day 7- 10 after initiation of α-blockade, and 7 days, 3 and 6 months post surgery
Change in Vascular Function indices by doppler Ultrasonography of the brachial artery from baseline at after alpha blockade and at after surgery
Flow mediated dilation of brachial artery diameter pre and post sublingual isosorbide dinitrate in millimeter
Measured: at baseline (Day 1), at Day 7- 10 after initiation of α-blockade, and 7 days, 3 and 6 months post adrenalectomy/ Paraganglioma excision
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2021
- Study start19 Jan 2019
- Primary completion30 Nov 2021
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for PheochromocytomaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Sanjay Gandhi Postgraduate Institute of Medical Sciences
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Gaurav Agarwal, Sanjay Gandhi Postgraduate Institute of Medical Sciences
- Investigators
- Gaurav Agarwal, MS,DNB,PDC, Principal investigator, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05082311
- Sponsor's protocol ID
- 2018-185-Mch-EXP-4
- Acronym
- PheoCard
- Status last verified
- Feb 2022
- First submitted
- 25 Jul 2021
- Last updated
- 10 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Agarwal G, Sadacharan D, Kapoor A, Batra A, Dabadghao P, Chand G, Mishra A, Agarwal A, Verma AK, Mishra SK. Cardiovascular dysfunction and catecholamine cardiomyopathy in pheochromocytoma patients and their reversal following surgical cure: results of a prospective case-control study. Surgery. 2011 Dec;150(6):1202-11. doi: 10.1016/j.surg.2011.09.001.
PubMed 22136841Agarwal G, Mishra AK, Kapoor A, Agarwal A, Bhatia E, Mishra SK. Reversal of catecholamine induced cardiomyopathy in a patient with bilateral malignant pheochromocytoma. J Assoc Physicians India. 2001 Dec;49:1193-6.
PubMed 11996444Ding L, Zhu WL, Zeng ZP, Li HZ, Ji J, Fang LG, Sun JP. Subclinical left ventricular systolic dysfunction detected by two-dimensional speckle tracking echocardiography in patients with pheochromocytoma and paraganglioma and preserved ejection fraction. Echocardiography. 2018 Feb;35(2):184-189. doi: 10.1111/echo.13752. Epub 2017 Nov 22.
PubMed 29168209Vishvak Chanthar KMM, Khanna R, Agarwal G, Rout SR, Kapoor A, Sabaretnam M, Chand G, Mishra A, Agarwal A, Mishra SK. Cardiac Changes and Their Reversal Following Curative Surgery in Pheochromocytoma: PheoCard Prospective Cohort Study. World J Surg. 2023 Feb;47(2):304-311. doi: 10.1007/s00268-022-06731-6. Epub 2022 Oct 10.
PubMed 36210362
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort Study of Objective Cardiac and Vascular Changes in Pheochromocytoma and Paraganglioma and Their Reversal Following Curative Surgery
- ClinicalTrials.gov ID
- NCT05082311
- Acronym / sponsor ID
- PheoCard / 2018-185-Mch-EXP-4
- Conditions
- Pheochromocytoma, Paraganglioma, Cardiovascular Morbidity
- Keywords
- Pheochromocytoma, Paraganglioma, Cardio vascular manifestations, Cardiomyopathy, Speckle Tracking echocardiography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Sanjay Gandhi Postgraduate Institute of Medical SciencesOther government
- Study start
- 19 Jan 2019 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 18 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with Pheochromocytoma/Paraganglioma (secretory, extra adrenal pheochromocytoma) | – | Other: Observational studyPatients included in this cohort (n=50) are those who are diagnosed of Pheochromocytoma / Paraganglioma, willing to consent for the study and not on α-blockade at the time of recruitment into study, while can be on any other anti hypertensives Patients in this group, besides the usual evaluation of Pheochromocytoma / Paraganglioma, will also undergo detailed cardiac and vascular evaluation, which will be done at diagnosis, at 7- 10 days of α-blockade, and 7 days, 3 and 6 months post adrenalectomy/ Paraganglioma excision The cardiovascular 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 |
| Essential Hypertensive Groups | – | Other: Observational studyThis is a contemporary age- and gender-matched control group This group includes 10 newly detected (within 3 months) Essential Hypertensive patients, who will undergo treatment with standard anti- HT medications Cardiac evaluation will be done at baseline and after 3 months of anti hypertensive medications |
| Healthy Individuals | – | Other: Observational studyThis is a contemporary age- and gender-matched control group This group includes 10 Healthy individuals (normal in physical examination, ECG , Echo), that include hospital staff nurses, technicians, doctors whom would be requested to volunteer Cardiac evaluation will be done at the start of study and after 6 months |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study group will include 50 biochemically and histopathology proven Pheochromocytoma /Paraganglioma patients, who after 1 to 3 weeks of α-adrenoceptor blockade with oral prazosin will 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.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational studyThis is an observational study | Other | Essential Hypertensive Groups, Healthy Individuals, Patients with Pheochromocytoma/Paraganglioma (secretory, extra adrenal pheochromocytoma) |
Primary outcome
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
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
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2022.
- Results publication: PubMed 22136841Agarwal G, Sadacharan D, Kapoor A, Batra A, Dabadghao P, Chand G, Mishra A, Agarwal A, Verma AK, Mishra SK. Cardiovascular dysfunction and catecholamine cardiomyopathy in pheochromocytoma patients and their reversal following surgical cure: results of a prospective case-control study. Surgery. 2011 Dec;150(6):1202-11. doi: 10.1016/j.surg.2011.09.001.
- Results publication: PubMed 11996444Agarwal G, Mishra AK, Kapoor A, Agarwal A, Bhatia E, Mishra SK. Reversal of catecholamine induced cardiomyopathy in a patient with bilateral malignant pheochromocytoma. J Assoc Physicians India. 2001 Dec;49:1193-6.
- Results publication: PubMed 29168209Ding L, Zhu WL, Zeng ZP, Li HZ, Ji J, Fang LG, Sun JP. Subclinical left ventricular systolic dysfunction detected by two-dimensional speckle tracking echocardiography in patients with pheochromocytoma and paraganglioma and preserved ejection fraction. Echocardiography. 2018 Feb;35(2):184-189. doi: 10.1111/echo.13752. Epub 2017 Nov 22.
- Derived from this study: PubMed 36210362Vishvak Chanthar KMM, Khanna R, Agarwal G, Rout SR, Kapoor A, Sabaretnam M, Chand G, Mishra A, Agarwal A, Mishra SK. Cardiac Changes and Their Reversal Following Curative Surgery in Pheochromocytoma: PheoCard Prospective Cohort Study. World J Surg. 2023 Feb;47(2):304-311. doi: 10.1007/s00268-022-06731-6. Epub 2022 Oct 10.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gaurav Agarwal, MS,DNB,PDC principal investigator
Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pheochromocytoma and Paraganglioma, run by Sanjay Gandhi Postgraduate Institute of Medical Sciences at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05082311, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2022.