Catecholamine; OverproductionSYMPACTNCT04495231
Sympathetic Activity and Cardiometabolic Complications
An observational study of Catecholamine; Overproduction and Catecholamine; Secretion, run by University of Turin, Italy at 1 site in Italy.
Trial summary
Recent studies on catecholamine physiology have shown a direct correlation with arterial hypertension, overcoming the exclusive role in the diagnosis and follow-up of chromaffin tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Catecholamine; Overproduction, Catecholamine; Secretion, Metabolic Syndrome
- How many people
- 1,380 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2007to 1 Jul 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients who performed a 24h urinary metanephrines assay at the laboratory of "City of Health and Science" hospital in Turin between 2007 and 2015, with availability of full clinical data due to hospitalization at the same hospital contextually to the dosage or within ± 6 months. Exclusion criteria are specified in the appropriate section.
Who may be able to join
- Measurement of 24h urinary metanephrines at the laboratory of "City of Health and Science" hospital in Turin between 2007 and 2015
- Availability of contextual clinical patient data as collected in prospective registries of Piedmont region
Who cannot join
- Diagnosis of pheochromocytoma or paraganglioma (at the time of urinary metanephrines collection or within the following 5 years)
- Diagnosis of other forms of secondary hypertension
- Previous cardiovascular or cerebrovascular event
- Chronic heart failure
- eGFR < 50 ml/min (according to CKD-EPI)
- Liver cirrhosis
Show all 20Show fewer
- Acute conditions and/or hospitalization in ICU (at the time of urinary metanephrines collection)
- Assumption of acetaminophen during the day before the 24-hour urine collection
- Therapy with labetalol
- Therapy with sotalol
- Therapy with alpha-methyldopa
- Therapy with MAO inhibitors
- Therapy with tricyclic antidepressants
- Therapy with buspirone
- Therapy with phenoxybenzamine
- Therapy with sulfasalazine
- Therapy with L-Dopa
- Therapy with sympathomimetic drugs or other vasopressors
- Alcohol abuse
- Cocaine abuse
Trial locations and contacts
1 site in 1 country.
Italy1 site
Division of Endocrinology, Diabetology and Metabolism; University of Turin
Turin, Piedmont, 10126
About this study
Official title: Association Between Enhanced Sympathetic Activity and Cardiometabolic Complications: a Cross-sectional Study on Predictive Power of 24-hour Urinary Metanephrines (SYMPACT)
Recent studies on catecholamine physiology have shown a direct correlation with arterial hypertension, overcoming the exclusive role in the diagnosis and follow-up of chromaffin tumors.
Nevertheless, in literature, few studies explore and reveal the utility of testing metanephrines for the evaluation of sympathetic activity and its associated cardiometabolic complications in patients with essential hypertension.
Read the detailed description
Catecholamines (noradrenaline, adrenaline and dopamine) are adaptive and maladaptive stress hormones.
In the classic "fight or flight" mechanism, they activate behavioral and physiological processes that facilitate the overcoming of stress; for instance, challenged by a physical stressor, an organism responds to the threat either fighting and prevailing or accepting defeat and fleeing in avoidance.
In the pathological context, an excessive catecholamine secretion is typical of the chromaffin tissue tumors, determining a clinical picture characterized by blood pressure elevation, tachycardia, anxiety, pallor, sweating and headache.
COMT enzyme catalyzes the O-methylation of the 3-hydroxyl group of catecholamines. The O-methylated derivatives of noradrenaline, adrenaline and dopamine are normetanephrine, metanephrine and 3-methoxytyramine, respectively. The term "metanephrines" is generally used to collectively refer to the first two compounds.
Compared to catecholamines, metanephrines are characterized by longer half-life and more stable levels over time. Their superior accuracy for the diagnosis and follow-up of pheochromocytoma and paraganglioma (PPGL) has been widely proved.
Excluding patients with PPGL, however, metanephrines can be more broadly considered as reliable markers of the whole sympathetic system activity; therefore, their levels may be hypothesized to be associated to a higher rate of concurrent cardiometabolic complications and, if so, could be useful for the stratification of cardiovascular risk.
- Conditions
- Catecholamine; Overproduction, Catecholamine; Secretion, Metabolic Syndrome, Hypertensive Heart Disease, Hypertensive Kidney Disease, Diabetes Mellitus, Type 2
- Keywords
- Normetanephrine, Metanephrine, Sympathetic Nervous System, Cardiovascular System, Cardiometabolic Complications, Catecholamine; Overproduction, Catecholamine; Secretion, Metabolic Syndrome, Hypertensive Heart Disease, Hypertensive Kidney Disease, Diabetes Mellitus, Type 2, Hypertension,Essential
- Medical subject headings
- Metabolic Syndrome, Hypertensive Nephropathy, Diabetes Mellitus, Type 2, Essential Hypertension
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of left ventricular hypertrophy
The value of urinary metanephrines will be evaluated as a possible predictor of the presence of left ventricular hypertrophy
Measured: At baseline
Presence of chronic kidney disease
The value of urinary metanephrines will be evaluated as a possible predictor of the presence of chronic kidney disease
Measured: At baseline
Presence of type 2 diabetes mellitus
The value of urinary metanephrines will be evaluated as a possible predictor of the presence of type 2 diabetes mellitus
Measured: At baseline
Presence of metabolic syndrome
The value of urinary metanephrines will be evaluated as a possible predictor of the presence of metabolic syndrome
Measured: At baseline
Secondary outcomes (14)
Systolic blood pressure (SBP)
The value of urinary metanephrines will be evaluated as a possible predictor of systolic blood pressure values (mmHg)
Measured: At baseline
Diastolic blood pressure (DBP)
The value of urinary metanephrines will be evaluated as a possible predictor of diastolic blood pressure values (mmHg)
Measured: At baseline
Resting heart rate
The value of urinary metanephrines will be evaluated as a possible predictor of resting heart rate (bpm)
Measured: At baseline
eGFR
The value of urinary metanephrines will be evaluated as a possible predictor of eGFR values (ml/min, as estimated by CKD-EPI formula)
Measured: At baseline
Urinary albumin/creatinine ratio
The value of urinary metanephrines will be evaluated as a possible predictor of albumin/creatinine ratio values (mg/mmol)
Measured: At baseline
Fasting glucose
The value of urinary metanephrines will be evaluated as a possible predictor of fasting glucose values (mg/dl)
Measured: At baseline
Total cholesterol
The value of urinary metanephrines will be evaluated as a possible predictor of total cholesterol values (mg/dl)
Measured: At baseline
HDL cholesterol
The value of urinary metanephrines will be evaluated as a possible predictor of HDL cholesterol values (mg/dl)
Measured: At baseline
LDL cholesterol
The value of urinary metanephrines will be evaluated as a possible predictor of LDL cholesterol values (mg/dl, as estimated by Friedewald formula)
Measured: At baseline
Triglycerides
The value of urinary metanephrines will be evaluated as a possible predictor of triglycerides values (mg/dl)
Measured: At baseline
Body Mass Index (BMI)
The value of urinary metanephrines will be evaluated as a possible predictor of BMI values (kg/m2)
Measured: At baseline
Cardiovascular risk as estimated by Framingham Risk Score (FRS)
The value of urinary metanephrines will be evaluated as a possible predictor of cardiovascular risk as estimated by FRS; FRS is expressed as a percentage, with higher values indicating higher risk; patients in which the risk estimation is not applicable will be excluded from the analysis
Measured: At baseline
Cardiovascular risk as estimated by Systematic COronary Risk Evaluation (SCORE)
The value of urinary metanephrines will be evaluated as a possible predictor of cardiovascular risk as estimated by SCORE; SCORE is expressed as a percentage, with higher values indicating higher risk; patients in which the risk estimation is not applicable will be excluded from the analysis
Measured: At baseline
Cardiovascular risk as estimated by Progetto Cuore Score (english translation: "Heart Project Score")
The value of urinary metanephrines will be evaluated as a possible predictor of cardiovascular risk as estimated by Progetto Cuore Score; Progetto Cuore Score is expressed as a percentage, with higher values indicating higher risk; patients in which the risk estimation is not applicable will be excluded from the analysis
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2020
- Study start1 Sep 2007
- Primary completion1 Jul 2015
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Catecholamine; OverproductionStudies 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 1,380 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mauro Maccario, University of Turin, Italy
- Investigators
- Mauro Maccario, MD, Principal investigator, Endocrinology, Diabetology and Metabolism; University of TurinEzio Ghigo, MD, Study chair, Endocrinology, Diabetology and Metabolism; University of Turin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04495231
- Sponsor's protocol ID
- SympAct 1
- Acronym
- SYMPACT
- Status last verified
- Jul 2020
- First submitted
- 27 Jul 2020
- Last updated
- 31 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ton QV, Hammes SR. Recent insights on circulating catecholamines in hypertension. Curr Hypertens Rep. 2014 Dec;16(12):498. doi: 10.1007/s11906-014-0498-9.
PubMed 25304108Esler M. The sympathetic nervous system in hypertension: back to the future? Curr Hypertens Rep. 2015 Feb;17(2):11. doi: 10.1007/s11906-014-0519-8.
PubMed 25680900Coulson JM. The relationship between blood pressure variability and catecholamine metabolites: a pilot study. J Hum Hypertens. 2015 Jan;29(1):50-2. doi: 10.1038/jhh.2014.23. Epub 2014 Apr 3.
PubMed 24694800Lenders JW, Duh QY, Eisenhofer G, Gimenez-Roqueplo AP, Grebe SK, Murad MH, Naruse M, Pacak K, Young WF Jr; Endocrine Society. Pheochromocytoma and paraganglioma: an endocrine society clinical practice guideline. J Clin Endocrinol Metab. 2014 Jun;99(6):1915-42. doi: 10.1210/jc.2014-1498.
PubMed 24893135Okuyama Y, Sakata Y. [Device treatment approaches targeting the sympathetic nervous system in patients with resistant hypertension]. Nihon Rinsho. 2015 Nov;73(11):1857-63. Japanese.
PubMed 26619659Grassi G, Mark A, Esler M. The sympathetic nervous system alterations in human hypertension. Circ Res. 2015 Mar 13;116(6):976-90. doi: 10.1161/CIRCRESAHA.116.303604.
PubMed 25767284Rothwell PM, Howard SC, Dolan E, O'Brien E, Dobson JE, Dahlof B, Sever PS, Poulter NR. Prognostic significance of visit-to-visit variability, maximum systolic blood pressure, and episodic hypertension. Lancet. 2010 Mar 13;375(9718):895-905. doi: 10.1016/S0140-6736(10)60308-X.
PubMed 20226988Esler M, Lambert G, Jennings G. Increased regional sympathetic nervous activity in human hypertension: causes and consequences. J Hypertens Suppl. 1990 Dec;8(7):S53-7.
PubMed 1965656Eisenhofer G, Kopin IJ, Goldstein DS. Catecholamine metabolism: a contemporary view with implications for physiology and medicine. Pharmacol Rev. 2004 Sep;56(3):331-49. doi: 10.1124/pr.56.3.1.
PubMed 15317907Tank AW, Lee Wong D. Peripheral and central effects of circulating catecholamines. Compr Physiol. 2015 Jan;5(1):1-15. doi: 10.1002/cphy.c140007.
PubMed 25589262Goldstein DS, Eisenhofer G, Kopin IJ. Sources and significance of plasma levels of catechols and their metabolites in humans. J Pharmacol Exp Ther. 2003 Jun;305(3):800-11. doi: 10.1124/jpet.103.049270. Epub 2003 Mar 20.
PubMed 12649306Eisenhofer G, Friberg P, Pacak K, Goldstein DS, Murphy DL, Tsigos C, Quyyumi AA, Brunner HG, Lenders JW. Plasma metadrenalines: do they provide useful information about sympatho-adrenal function and catecholamine metabolism? Clin Sci (Lond). 1995 May;88(5):533-42. doi: 10.1042/cs0880533.
PubMed 7614812Masuo K, Kawaguchi H, Mikami H, Ogihara T, Tuck ML. Serum uric acid and plasma norepinephrine concentrations predict subsequent weight gain and blood pressure elevation. Hypertension. 2003 Oct;42(4):474-80. doi: 10.1161/01.HYP.0000091371.53502.D3. Epub 2003 Sep 2.
PubMed 12953019Dudenbostel T, Acelajado MC, Pisoni R, Li P, Oparil S, Calhoun DA. Refractory Hypertension: Evidence of Heightened Sympathetic Activity as a Cause of Antihypertensive Treatment Failure. Hypertension. 2015 Jul;66(1):126-33. doi: 10.1161/HYPERTENSIONAHA.115.05449. Epub 2015 May 18.
PubMed 25987662Flaa A, Aksnes TA, Kjeldsen SE, Eide I, Rostrup M. Increased sympathetic reactivity may predict insulin resistance: an 18-year follow-up study. Metabolism. 2008 Oct;57(10):1422-7. doi: 10.1016/j.metabol.2008.05.012.
PubMed 18803948
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Enhanced Sympathetic Activity and Cardiometabolic Complications: a Cross-sectional Study on Predictive Power of 24-hour Urinary Metanephrines (SYMPACT)
- ClinicalTrials.gov ID
- NCT04495231
- Acronym / sponsor ID
- SYMPACT / SympAct 1
- Conditions
- Catecholamine; Overproduction, Catecholamine; Secretion, Metabolic Syndrome, Hypertensive Heart Disease, Hypertensive Kidney Disease, Diabetes Mellitus, Type 2
- Keywords
- Normetanephrine, Metanephrine, Sympathetic Nervous System, Cardiovascular System, Cardiometabolic Complications, Catecholamine; Overproduction, Catecholamine; Secretion, Metabolic Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,380 participants (actual)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Study start
- 1 Sep 2007 (actual)
- Primary completion
- 1 Jul 2015 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 31 Jul 2020 (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.
Recent studies on catecholamine physiology have shown a direct correlation with arterial hypertension, overcoming the exclusive role in the diagnosis and follow-up of chromaffin tumors.
Nevertheless, in literature, few studies explore and reveal the utility of testing metanephrines for the evaluation of sympathetic activity and its associated cardiometabolic complications in patients with essential hypertension.
Detailed description
Catecholamines (noradrenaline, adrenaline and dopamine) are adaptive and maladaptive stress hormones.
In the classic "fight or flight" mechanism, they activate behavioral and physiological processes that facilitate the overcoming of stress; for instance, challenged by a physical stressor, an organism responds to the threat either fighting and prevailing or accepting defeat and fleeing in avoidance.
In the pathological context, an excessive catecholamine secretion is typical of the chromaffin tissue tumors, determining a clinical picture characterized by blood pressure elevation, tachycardia, anxiety, pallor, sweating and headache.
COMT enzyme catalyzes the O-methylation of the 3-hydroxyl group of catecholamines. The O-methylated derivatives of noradrenaline, adrenaline and dopamine are normetanephrine, metanephrine and 3-methoxytyramine, respectively. The term "metanephrines" is generally used to collectively refer to the first two compounds.
Compared to catecholamines, metanephrines are characterized by longer half-life and more stable levels over time. Their superior accuracy for the diagnosis and follow-up of pheochromocytoma and paraganglioma (PPGL) has been widely proved.
Excluding patients with PPGL, however, metanephrines can be more broadly considered as reliable markers of the whole sympathetic system activity; therefore, their levels may be hypothesized to be associated to a higher rate of concurrent cardiometabolic complications and, if so, could be useful for the stratification of cardiovascular risk.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who performed a 24h urinary metanephrines assay at the laboratory of "City of Health and Science" hospital in Turin between 2007 and 2015, with availability of full clinical data due to hospitalization at the same hospital contextually to the dosage or within ± 6 months. Exclusion criteria are specified in the appropriate section.
Key inclusion criteria (2 listed)
- Measurement of 24h urinary metanephrines at the laboratory of "City of Health and Science" hospital in Turin between 2007 and 2015
- Availability of contextual clinical patient data as collected in prospective registries of Piedmont region
Key exclusion criteria (20 listed)
- Diagnosis of pheochromocytoma or paraganglioma (at the time of urinary metanephrines collection or within the following 5 years)
- Diagnosis of other forms of secondary hypertension
- Previous cardiovascular or cerebrovascular event
- Chronic heart failure
- eGFR < 50 ml/min (according to CKD-EPI)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Presence of left ventricular hypertrophy
Time frame: At baseline
The value of urinary metanephrines will be evaluated as a possible predictor of the presence of left ventricular hypertrophy
Presence of chronic kidney disease
Time frame: At baseline
The value of urinary metanephrines will be evaluated as a possible predictor of the presence of chronic kidney disease
Presence of type 2 diabetes mellitus
Time frame: At baseline
The value of urinary metanephrines will be evaluated as a possible predictor of the presence of type 2 diabetes mellitus
Presence of metabolic syndrome
Time frame: At baseline
The value of urinary metanephrines will be evaluated as a possible predictor of the presence of metabolic syndrome
14 secondary outcomes
Systolic blood pressure (SBP)
Time frame: At baseline
Diastolic blood pressure (DBP)
Time frame: At baseline
Resting heart rate
Time frame: At baseline
eGFR
Time frame: At baseline
Urinary albumin/creatinine ratio
Time frame: At baseline
Fasting glucose
Time frame: At baseline
Total cholesterol
Time frame: At baseline
HDL cholesterol
Time frame: At baseline
LDL cholesterol
Time frame: At baseline
Triglycerides
Time frame: At baseline
Body Mass Index (BMI)
Time frame: At baseline
Cardiovascular risk as estimated by Framingham Risk Score (FRS)
Time frame: At baseline
Cardiovascular risk as estimated by Systematic COronary Risk Evaluation (SCORE)
Time frame: At baseline
Cardiovascular risk as estimated by Progetto Cuore Score (english translation: "Heart Project Score")
Time frame: At baseline
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 31 Jul 2020.
- Background: PubMed 25304108Ton QV, Hammes SR. Recent insights on circulating catecholamines in hypertension. Curr Hypertens Rep. 2014 Dec;16(12):498. doi: 10.1007/s11906-014-0498-9.
- Background: PubMed 25680900Esler M. The sympathetic nervous system in hypertension: back to the future? Curr Hypertens Rep. 2015 Feb;17(2):11. doi: 10.1007/s11906-014-0519-8.
- Background: PubMed 24694800Coulson JM. The relationship between blood pressure variability and catecholamine metabolites: a pilot study. J Hum Hypertens. 2015 Jan;29(1):50-2. doi: 10.1038/jhh.2014.23. Epub 2014 Apr 3.
- Background: PubMed 24893135Lenders JW, Duh QY, Eisenhofer G, Gimenez-Roqueplo AP, Grebe SK, Murad MH, Naruse M, Pacak K, Young WF Jr; Endocrine Society. Pheochromocytoma and paraganglioma: an endocrine society clinical practice guideline. J Clin Endocrinol Metab. 2014 Jun;99(6):1915-42. doi: 10.1210/jc.2014-1498.
- Background: PubMed 26619659Okuyama Y, Sakata Y. [Device treatment approaches targeting the sympathetic nervous system in patients with resistant hypertension]. Nihon Rinsho. 2015 Nov;73(11):1857-63. Japanese.
- Background: PubMed 25767284Grassi G, Mark A, Esler M. The sympathetic nervous system alterations in human hypertension. Circ Res. 2015 Mar 13;116(6):976-90. doi: 10.1161/CIRCRESAHA.116.303604.
- Background: PubMed 20226988Rothwell PM, Howard SC, Dolan E, O'Brien E, Dobson JE, Dahlof B, Sever PS, Poulter NR. Prognostic significance of visit-to-visit variability, maximum systolic blood pressure, and episodic hypertension. Lancet. 2010 Mar 13;375(9718):895-905. doi: 10.1016/S0140-6736(10)60308-X.
- Background: PubMed 1965656Esler M, Lambert G, Jennings G. Increased regional sympathetic nervous activity in human hypertension: causes and consequences. J Hypertens Suppl. 1990 Dec;8(7):S53-7.
- Background: PubMed 15317907Eisenhofer G, Kopin IJ, Goldstein DS. Catecholamine metabolism: a contemporary view with implications for physiology and medicine. Pharmacol Rev. 2004 Sep;56(3):331-49. doi: 10.1124/pr.56.3.1.
- Background: PubMed 25589262Tank AW, Lee Wong D. Peripheral and central effects of circulating catecholamines. Compr Physiol. 2015 Jan;5(1):1-15. doi: 10.1002/cphy.c140007.
- Background: PubMed 12649306Goldstein DS, Eisenhofer G, Kopin IJ. Sources and significance of plasma levels of catechols and their metabolites in humans. J Pharmacol Exp Ther. 2003 Jun;305(3):800-11. doi: 10.1124/jpet.103.049270. Epub 2003 Mar 20.
- Background: PubMed 7614812Eisenhofer G, Friberg P, Pacak K, Goldstein DS, Murphy DL, Tsigos C, Quyyumi AA, Brunner HG, Lenders JW. Plasma metadrenalines: do they provide useful information about sympatho-adrenal function and catecholamine metabolism? Clin Sci (Lond). 1995 May;88(5):533-42. doi: 10.1042/cs0880533.
- Individual participant dataSharing planned: No
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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.
Mauro Maccario, MD principal investigator
Endocrinology, Diabetology and Metabolism; University of Turin
Ezio Ghigo, MD study chair
Endocrinology, Diabetology and Metabolism; University of Turin
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 Catecholamine; Overproduction and Catecholamine; Secretion, run by University of Turin, Italy at 1 site in Italy.
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 2 inclusion and 20 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 31 Jul 2020. 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 Italy. 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?
Presence of left ventricular hypertrophy (time frame: At baseline). The study lists 4 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 NCT04495231, which also lists 23 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 31 Jul 2020.