Obstructive Sleep ApneaNCT06626906
Predictive Value of Sleep Apnea-specific PTT Response for Incident Subclinical Abnormalities in LV Structure and Function in Cohort of moderate-to Severe OSA
An observational study of Obstructive Sleep Apnea, run by Xu J.
Trial summary
This observational study aims to provide evidence for identifying those who mostly suffer from LV injury and will help construct an optimal strategy for clinical practice. The main question it aims to answer is: Could acute PTT response surrounding obstructive respiratory events predict the incidence of subclinical… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Echocardiography, Blood sampling for biomarker assays
- How many people
- 376 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2014to 31 May 2024
- 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: Inpatients aged 18 years and older, with moderate-to-severe OSA, who were diagnosed between January 1 2014, and December 31 2019 at The Affiliated Huaian No.1 People's Hospital of Nanjing Medical University, the First Affiliated Hospital of Nanjing Medical University, and the Affiliated Hospital of Xuzhou Medical University.
Who may be able to join
- ≥18 years old;
- Moderate to severe OSA(AHI≥15 times/hour).
Who cannot join
- baseline hypoxia;
- other sleep disorders;
- received regular CPAP treatment(on average of ≥ 4 hours for CPAP use per night during the retrospective period);
- the prevalent diseases at baseline might have influenced the results of echocardiographic results: hypertension chronic atrial fibrillation, atrioventricular block, bundle branch blocks, a permanent pacemaker, heart failure, valvular heart disease, pulmonary emboli, abnormal thyroid function, cardiomyopathies, pulmonary hypertension, use of digitalis, use of antiarrhythmic agents, use of beta-blockers, or use of calcium agonists affecting heart rate (HR), including verapamil and diltiazem.
About this study
Official title: Predictive Value of Sleep Apnea-specific Pulse Transit Time Response for Incident Subclinical Abnormalities in Left Ventricle Structure and Function in Cohort of moderate-to Severe Obstructive Sleep Apnea
This observational study aims to provide evidence for identifying those who mostly suffer from LV injury and will help construct an optimal strategy for clinical practice. The main question it aims to answer is:
Could acute PTT response surrounding obstructive respiratory events predict the incidence of subclinical abnormalities in LV structure and function in moderate-to-severe OSA patients? Participants who had undergone standard polysomnography and were diagnosed with moderate-to-severe OSA 5 years ago were required to complete the cardiac remodeling and function evaluation.
Read the detailed description
Obstructive sleep apnea (OSA) is a widely prevalent medical condition characterized by recurrent upper airway obstruction with intermittent hypoxia, sleep disruption, and increased ventilation. Serial studies have shown that OSA promotes oxidative stress, sympathetic activity, and intrathoracic pressure fluctuation, resulting in adverse cardiac structures and function. The cumulative data from observational studies have linked the apnea-hypopnea index (AHI), an indicator of OSA severity, with increased LV injury. As OSA is a highly heterogeneous disorder, with diverse pathways to disease, expression of disease, susceptibility to co-morbidities, and response to therapy. Hence, OSA is ideally suited to precision medicine approaches. While the current assessment relies on the AHI, this traditional metric poorly reflects the complex pathophysiological of OSA on cardiac injury.
Asymptotic cardiac dysfunction is not easily identified, and many sufferers remain undiagnosed in clinical practice. Focusing on recognition and treatment of subclinical cardiac injury early is a potentially powerful strategy to prevent progression to clinical or symptomatic heart failure. In OSA patients, the BP and heart rate (HR) changes occurring with obstructive events involve an initial decrease early in the event, a gradual increase during the terminal portion of the event, and an immediate surgeon resumption of ventilation. These acute hemodynamic and autonomic changes may be closely associated with the development and progression of cardiovascular disease. Whether this OSA-specific cardiovascular reactivity pattern is the potentially early warning indicator of cardiac injury is unknown.
A physiologic parameter termed pulse transit time (PTT) has been studied intensively as an indirect marker for variations in cardiovascular-related reactivity. It can be generally referred to as the time difference for a pulse wave to travel between two arterial sites. The speed at which this arterial pressure wave travels was used to assess nocturnal blood pressure variation, arterial stiffness changes, autonomic nervous response, and inspiratory effort. More experimentally focused investigations with PTT as a key measure in cardiovascular-related studies are being reported.
In the present study, the investigators examined acute PTT changes surrounding obstructive events, for PTT can be easily measured in standard polysomnography (PSG). The investigators hypothesized that the specific respiratory events PTT response would predict incident subclinical abnormalities in LV structure and function in a cohort of moderate-to-severe OSA without other confounded morbidities. The results of this study provide evidence for identifying those who mostly suffer from LV injury and will help construct an optimal strategy for clinical practice.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Echocardiography, Blood sampling for biomarker assays
- Keywords
- retrospective cohort, multicenter studies, observational study model
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Echocardiography, Blood sampling for biomarker assaysDiagnostic test
What is being measured
The primary outcome is the main question the study is designed to answer.
the cardiac remodeling evaluation
The echocardiogram was carried out using machines equipped with a 2.5-MHz probe. All 2D and Doppler images and measurements were obtained in agreement with the European Association of Echocardiography/American Society of Echocardiography guidelines.
Measures of LV remodeling included LV end-systolic (LVDs) in centimeters, and end-diastolic diameter (LVDd) in centimeters, interventricular septum thickness at end-diastole (IVSd) in centimeters, LV mass (LVM) in grams. LVM (LVMI) was calculated as the ratio of LVM in grams and body surface area in square meters. LVH was defined as an LVMI of 111 g/m2or 50 g/m2 in males and of 106 g/m2or 47 g/m2 in females.
Measured: from October 2023 to May 2024
the cardiac function evaluation
The echocardiogram was carried out using machines equipped with a 2.5-MHz probe. All 2D and Doppler images and measurements were obtained in agreement with the European Association of Echocardiography/American Society of Echocardiography guidelines.
Measures of LV diastolic function included the average of the septal and lateral mitral annular descent tissue Doppler velocity (E') in cm/s, early mitral inflow velocity E' in cm/s, and the ratio of E/E'. Measures of systolic function included LV ejection fraction (EF) in percentage using Simpson biplane method of disks in 2-chamber and 4-chamber apical views (a single view was used in cases where one view was technically suboptimal).
Measured: from October 2023 to May 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2024
- Study start1 Jan 2014
- Primary completion31 May 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies 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
- Retrospective
- Enrolment
- 376 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xu J
- Sponsor type
- University, hospital or other
- Collaborators
- The first affiliated Hospital of Nanjing Medical University, Jiangsu Province, The Affiliated Hospital of Xuzhou Medical University
- Responsible party
- Sponsor-investigator, Xu J, Huai'an No.1 People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06626906
- Sponsor's protocol ID
- YX-Z-2023-027-01
- Status last verified
- Oct 2024
- First submitted
- 26 Sep 2024
- Last updated
- 4 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Drager LF, Bortolotto LA, Figueiredo AC, Silva BC, Krieger EM, Lorenzi-Filho G. Obstructive sleep apnea, hypertension, and their interaction on arterial stiffness and heart remodeling. Chest. 2007 May;131(5):1379-86. doi: 10.1378/chest.06-2703.
PubMed 17494787Alomri RMA, Kennedy GA, Wali S, Alhejaili F, Zelko M, Robinson SR. Association between cognitive dysfunction and nocturnal peaks of blood pressure estimated from pulse transit time in obstructive sleep apnoea. Sleep Med. 2022 Feb;90:185-191. doi: 10.1016/j.sleep.2022.01.005. Epub 2022 Jan 10.
PubMed 35183866Nisbet LC, Yiallourou SR, Nixon GM, Biggs SN, Davey MJ, Trinder J, Walter LM, Horne RS. Characterization of the acute pulse transit time response to obstructive apneas and hypopneas in preschool children with sleep-disordered breathing. Sleep Med. 2013 Nov;14(11):1123-31. doi: 10.1016/j.sleep.2013.06.010. Epub 2013 Aug 3.
PubMed 24047534Nisbet LC, Nixon GM, Yiallourou SR, Biggs SN, Davey MJ, Trinder J, Walter LM, Horne RS. Sleep-disordered breathing does not affect nocturnal dipping, as assessed by pulse transit time, in preschool children: evidence for early intervention to prevent adverse cardiovascular effects? Sleep Med. 2014 Apr;15(4):464-71. doi: 10.1016/j.sleep.2013.11.787. Epub 2014 Feb 10.
PubMed 24684978Foo JY, Wilson SJ, Williams GR, Harris MA, Cooper DM. Pulse transit time changes observed with different limb positions. Physiol Meas. 2005 Dec;26(6):1093-102. doi: 10.1088/0967-3334/26/6/018. Epub 2005 Nov 7.
PubMed 16311456Kwon Y, Jacobs DR Jr, Lutsey PL, Brumback L, Chirinos JA, Mariani S, Redline S, Duprez DA. "Sleep disordered breathing and ECG R-wave to radial artery pulse delay, The Multi-Ethnic Study of Atherosclerosis". Sleep Med. 2018 Aug;48:172-179. doi: 10.1016/j.sleep.2018.05.005. Epub 2018 May 21.
PubMed 29960211Foo JY, Lim CS. Pulse transit time as an indirect marker for variations in cardiovascular related reactivity. Technol Health Care. 2006;14(2):97-108.
PubMed 16720953Parish JM, Somers VK. Obstructive sleep apnea and cardiovascular disease. Mayo Clin Proc. 2004 Aug;79(8):1036-46. doi: 10.4065/79.8.1036.
PubMed 15301332Imadojemu VA, Gleeson K, Gray KS, Sinoway LI, Leuenberger UA; New Collective Author. Obstructive apnea during sleep is associated with peripheral vasoconstriction. Am J Respir Crit Care Med. 2002 Jan 1;165(1):61-6. doi: 10.1164/ajrccm.165.1.2009062.
PubMed 11779731Ogilvie RP, Genuardi MV, Magnani JW, Redline S, Daviglus ML, Shah N, Kansal M, Cai J, Ramos AR, Hurwitz BE, Ponce S, Patel SR, Rodriguez CJ. Association Between Sleep Disordered Breathing and Left Ventricular Function: A Cross-Sectional Analysis of the ECHO-SOL Ancillary Study. Circ Cardiovasc Imaging. 2020 May;13(5):e009074. doi: 10.1161/CIRCIMAGING.119.009074. Epub 2020 May 15.
PubMed 32408831Bradley TD, Floras JS. Sleep apnea and heart failure: Part I: obstructive sleep apnea. Circulation. 2003 Apr 1;107(12):1671-8. doi: 10.1161/01.CIR.0000061757.12581.15. No abstract available.
PubMed 12668504Gottlieb DJ, Yenokyan G, Newman AB, O'Connor GT, Punjabi NM, Quan SF, Redline S, Resnick HE, Tong EK, Diener-West M, Shahar E. Prospective study of obstructive sleep apnea and incident coronary heart disease and heart failure: the sleep heart health study. Circulation. 2010 Jul 27;122(4):352-60. doi: 10.1161/CIRCULATIONAHA.109.901801. Epub 2010 Jul 12.
PubMed 20625114
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of Sleep Apnea-specific Pulse Transit Time Response for Incident Subclinical Abnormalities in Left Ventricle Structure and Function in Cohort of moderate-to Severe Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT06626906
- Acronym / sponsor ID
- YX-Z-2023-027-01
- Conditions
- Obstructive Sleep Apnea
- Keywords
- retrospective cohort, multicenter studies, observational study model
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 376 participants (actual)
- Lead sponsor
- Xu JUniversity, hospital or other
- Collaborators
- The first affiliated Hospital of Nanjing Medical University, Jiangsu Province, The Affiliated Hospital of Xuzhou Medical University
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 4 Oct 2024 (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.
This observational study aims to provide evidence for identifying those who mostly suffer from LV injury and will help construct an optimal strategy for clinical practice. The main question it aims to answer is:
Could acute PTT response surrounding obstructive respiratory events predict the incidence of subclinical abnormalities in LV structure and function in moderate-to-severe OSA patients? Participants who had undergone standard polysomnography and were diagnosed with moderate-to-severe OSA 5 years ago were required to complete the cardiac remodeling and function evaluation.
Detailed description
Obstructive sleep apnea (OSA) is a widely prevalent medical condition characterized by recurrent upper airway obstruction with intermittent hypoxia, sleep disruption, and increased ventilation. Serial studies have shown that OSA promotes oxidative stress, sympathetic activity, and intrathoracic pressure fluctuation, resulting in adverse cardiac structures and function. The cumulative data from observational studies have linked the apnea-hypopnea index (AHI), an indicator of OSA severity, with increased LV injury. As OSA is a highly heterogeneous disorder, with diverse pathways to disease, expression of disease, susceptibility to co-morbidities, and response to therapy. Hence, OSA is ideally suited to precision medicine approaches. While the current assessment relies on the AHI, this traditional metric poorly reflects the complex pathophysiological of OSA on cardiac injury.
Asymptotic cardiac dysfunction is not easily identified, and many sufferers remain undiagnosed in clinical practice. Focusing on recognition and treatment of subclinical cardiac injury early is a potentially powerful strategy to prevent progression to clinical or symptomatic heart failure. In OSA patients, the BP and heart rate (HR) changes occurring with obstructive events involve an initial decrease early in the event, a gradual increase during the terminal portion of the event, and an immediate surgeon resumption of ventilation. These acute hemodynamic and autonomic changes may be closely associated with the development and progression of cardiovascular disease. Whether this OSA-specific cardiovascular reactivity pattern is the potentially early warning indicator of cardiac injury is unknown.
A physiologic parameter termed pulse transit time (PTT) has been studied intensively as an indirect marker for variations in cardiovascular-related reactivity. It can be generally referred to as the time difference for a pulse wave to travel between two arterial sites. The speed at which this arterial pressure wave travels was used to assess nocturnal blood pressure variation, arterial stiffness changes, autonomic nervous response, and inspiratory effort. More experimentally focused investigations with PTT as a key measure in cardiovascular-related studies are being reported.
In the present study, the investigators examined acute PTT changes surrounding obstructive events, for PTT can be easily measured in standard polysomnography (PSG). The investigators hypothesized that the specific respiratory events PTT response would predict incident subclinical abnormalities in LV structure and function in a cohort of moderate-to-severe OSA without other confounded morbidities. The results of this study provide evidence for identifying those who mostly suffer from LV injury and will help construct an optimal strategy for clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Inpatients aged 18 years and older, with moderate-to-severe OSA, who were diagnosed between January 1 2014, and December 31 2019 at The Affiliated Huaian No.1 People's Hospital of Nanjing Medical University, the First Affiliated Hospital of Nanjing Medical University, and the Affiliated Hospital of Xuzhou Medical University.
Key inclusion criteria (2 listed)
- ≥18 years old;
- Moderate to severe OSA(AHI≥15 times/hour).
Key exclusion criteria (4 listed)
- baseline hypoxia;
- other sleep disorders;
- received regular CPAP treatment(on average of ≥ 4 hours for CPAP use per night during the retrospective period);
- the prevalent diseases at baseline might have influenced the results of echocardiographic results: hypertension chronic atrial fibrillation, atrioventricular block, bundle branch blocks, a permanent pacemaker, heart failure, valvular heart disease, pulmonary emboli, abnormal thyroid function, cardiomyopathies, pulmonary hypertension, use of digitalis, use of antiarrhythmic agents, use of beta-blockers, or use of calcium agonists affecting heart rate (HR), including verapamil and diltiazem.
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 |
|---|---|---|
| Echocardiography, Blood sampling for biomarker assays | Diagnostic test | – |
Primary outcome
the cardiac remodeling evaluation
Time frame: from October 2023 to May 2024
The echocardiogram was carried out using machines equipped with a 2.5-MHz probe. All 2D and Doppler images and measurements were obtained in agreement with the European Association of Echocardiography/American Society of Echocardiography guidelines. Measures of LV remodeling included LV end-systolic (LVDs) in centimeters, and end-diastolic diameter (LVDd) in centimeters, interventricular septum thickness at end-diastole (IVSd) in centimeters, LV mass (LVM) in grams. LVM (LVMI) was calculated as the ratio of LVM in grams and body surface area in square meters. LVH was defined as an LVMI of 111 g/m2or 50 g/m2 in males and of 106 g/m2or 47 g/m2 in females.
the cardiac function evaluation
Time frame: from October 2023 to May 2024
The echocardiogram was carried out using machines equipped with a 2.5-MHz probe. All 2D and Doppler images and measurements were obtained in agreement with the European Association of Echocardiography/American Society of Echocardiography guidelines. Measures of LV diastolic function included the average of the septal and lateral mitral annular descent tissue Doppler velocity (E') in cm/s, early mitral inflow velocity E' in cm/s, and the ratio of E/E'. Measures of systolic function included LV ejection fraction (EF) in percentage using Simpson biplane method of disks in 2-chamber and 4-chamber apical views (a single view was used in cases where one view was technically suboptimal).
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 4 Oct 2024.
- Background: PubMed 17494787Drager LF, Bortolotto LA, Figueiredo AC, Silva BC, Krieger EM, Lorenzi-Filho G. Obstructive sleep apnea, hypertension, and their interaction on arterial stiffness and heart remodeling. Chest. 2007 May;131(5):1379-86. doi: 10.1378/chest.06-2703.
- Results publication: PubMed 35183866Alomri RMA, Kennedy GA, Wali S, Alhejaili F, Zelko M, Robinson SR. Association between cognitive dysfunction and nocturnal peaks of blood pressure estimated from pulse transit time in obstructive sleep apnoea. Sleep Med. 2022 Feb;90:185-191. doi: 10.1016/j.sleep.2022.01.005. Epub 2022 Jan 10.
- Results publication: PubMed 24047534Nisbet LC, Yiallourou SR, Nixon GM, Biggs SN, Davey MJ, Trinder J, Walter LM, Horne RS. Characterization of the acute pulse transit time response to obstructive apneas and hypopneas in preschool children with sleep-disordered breathing. Sleep Med. 2013 Nov;14(11):1123-31. doi: 10.1016/j.sleep.2013.06.010. Epub 2013 Aug 3.
- Results publication: PubMed 24684978Nisbet LC, Nixon GM, Yiallourou SR, Biggs SN, Davey MJ, Trinder J, Walter LM, Horne RS. Sleep-disordered breathing does not affect nocturnal dipping, as assessed by pulse transit time, in preschool children: evidence for early intervention to prevent adverse cardiovascular effects? Sleep Med. 2014 Apr;15(4):464-71. doi: 10.1016/j.sleep.2013.11.787. Epub 2014 Feb 10.
- Results publication: PubMed 16311456Foo JY, Wilson SJ, Williams GR, Harris MA, Cooper DM. Pulse transit time changes observed with different limb positions. Physiol Meas. 2005 Dec;26(6):1093-102. doi: 10.1088/0967-3334/26/6/018. Epub 2005 Nov 7.
- Results publication: PubMed 29960211Kwon Y, Jacobs DR Jr, Lutsey PL, Brumback L, Chirinos JA, Mariani S, Redline S, Duprez DA. "Sleep disordered breathing and ECG R-wave to radial artery pulse delay, The Multi-Ethnic Study of Atherosclerosis". Sleep Med. 2018 Aug;48:172-179. doi: 10.1016/j.sleep.2018.05.005. Epub 2018 May 21.
- Results publication: PubMed 16720953Foo JY, Lim CS. Pulse transit time as an indirect marker for variations in cardiovascular related reactivity. Technol Health Care. 2006;14(2):97-108.
- Results publication: PubMed 15301332Parish JM, Somers VK. Obstructive sleep apnea and cardiovascular disease. Mayo Clin Proc. 2004 Aug;79(8):1036-46. doi: 10.4065/79.8.1036.
- Results publication: PubMed 11779731Imadojemu VA, Gleeson K, Gray KS, Sinoway LI, Leuenberger UA; New Collective Author. Obstructive apnea during sleep is associated with peripheral vasoconstriction. Am J Respir Crit Care Med. 2002 Jan 1;165(1):61-6. doi: 10.1164/ajrccm.165.1.2009062.
- Results publication: PubMed 32408831Ogilvie RP, Genuardi MV, Magnani JW, Redline S, Daviglus ML, Shah N, Kansal M, Cai J, Ramos AR, Hurwitz BE, Ponce S, Patel SR, Rodriguez CJ. Association Between Sleep Disordered Breathing and Left Ventricular Function: A Cross-Sectional Analysis of the ECHO-SOL Ancillary Study. Circ Cardiovasc Imaging. 2020 May;13(5):e009074. doi: 10.1161/CIRCIMAGING.119.009074. Epub 2020 May 15.
- Results publication: PubMed 12668504Bradley TD, Floras JS. Sleep apnea and heart failure: Part I: obstructive sleep apnea. Circulation. 2003 Apr 1;107(12):1671-8. doi: 10.1161/01.CIR.0000061757.12581.15. No abstract available.
- Results publication: PubMed 20625114Gottlieb DJ, Yenokyan G, Newman AB, O'Connor GT, Punjabi NM, Quan SF, Redline S, Resnick HE, Tong EK, Diener-West M, Shahar E. Prospective study of obstructive sleep apnea and incident coronary heart disease and heart failure: the sleep heart health study. Circulation. 2010 Jul 27;122(4):352-60. doi: 10.1161/CIRCULATIONAHA.109.901801. Epub 2010 Jul 12.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea, run by Xu J.
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 4 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 4 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
the cardiac remodeling evaluation (time frame: from October 2023 to May 2024). The study lists 2 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 NCT06626906, which also lists 12 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 4 Oct 2024.