Hypertension,NephropathyPhase 4NCT03692013
Nighttime Losartan in Continous Ambulatory Peritoneal Dialysis (NVCAPD)
A Phase 4 study testing Losartan in people with Hypertension,Nephropathy, run by Fifth Affiliated Hospital, Sun Yat-Sen University.
Trial summary
Hypertension is one of the most important independent risk factors for the prognosis of continous ambulatory peritoneal dialysis patients. The incident rate is high and the control rate is low. Nocturnal hypertension has been paid more attention in recent years. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypertension,Nephropathy
- What is being tested?
- Losartan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2018to 1 Dec 2023
- Phase
- Phase 4
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over 18 years old and <75 years.
- Diagnosed as chronic kidney disease 5th stage in accordance with the KDIGO guide 2012 (egfr < 15 ml/ (min 1.73m2)).
- Accept 3-5 bags daily, continous ambulatory peritoneal dialysis for >3 months.
- Ambulatory blood pressure monitoring indicates nighttime systolic blood pressure (SBP) > 120mmHg and / or diastolic blood pressure (DBP) > 70mmHg.
Who cannot join
- Night learning or work, irregular rest for a long time.
- Moderate and severe edema in difficult to correct
- Persistent atrial fibrillation.
- Severe anemia and severe dystrophy.
- Patients with postural hypotension or symptomatic hypotension.
- Severe side effects or contraindications of valsartan treatment.
Show all 12Show fewer
- Treatment of corticosteroids or other hormones at present.
- Unable to cooperate or unable to tolerate ambulatory blood pressure monitoring.
- Ineffective ambulatory blood pressure data.
- The clinical data were incomplete during the treatment period; end-point events occurred within 6 months or follow-up time was less than 6 months.
- In the first 3 months before admission, there were obvious cardiovascular and cerebrovascular diseases such as coronary syndrome, myocardial infarction or stroke.
- There were complications such as vascular disease, infection and bleeding within 1 months.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Nighttime Losartan on Prognosis of Nocturnal Hypertension Patients Undergoing Continous Ambulatory Peritoneal Dialysis
Hypertension is one of the most important independent risk factors for the prognosis of continous ambulatory peritoneal dialysis patients. The incident rate is high and the control rate is low. Nocturnal hypertension has been paid more attention in recent years. Compared to daytime blood pressure, nocturnal blood pressure is an independent and efficient prognostic indicator of hypertensive deaths and cardiovascular events, but it is lack of evidence about its impact on prognosis in peritoneal dialysis patients and the effective treatment program. Our previous cohort study suggests that the incidence of nocturnal hypertension in patients with chronic kidney disease is up to 71.22%, with a significant increase as the decline of renal function, and more severe target organ damage in patients with nocturnal hypertension: the decrease of glomerular filtration rate, left ventricular hypertrophy, and the increase of all cause death and cardiovascular death. Our small sample size study show that night time antihypertensive drugs can better control blood pressure and delay the development of left ventricular hypertrophy. These preliminary results suggest that nocturnal hypertension is closely related to the prognosis of chronic renal disease. Taking antihypertensive drugs at night is one of the options for controlling nocturnal hypertension. However, it is not clear whether taking antihypertensive drugs at night can improve the prognosis of maintenance peritoneal dialysis patients with nocturnal hypertension. To this end, the investigators collect continous ambulatory peritoneal dialysis patients with nocturnal hypertension, and propose a time selective use of losartan to intervene in nocturnal hypertension. By comparing the difference in the effects of losartan on the prognosis of maintenance peritoneal dialysis patients during the day or night, to further clarify the role of nocturnal hypertension in the prognosis of maintenance peritoneal dialysis patients, whether controlling nocturnal hypertension can improve the prognosis of maintenance peritoneal dialysis patients. The completion of study will optimize the prevention and treatment of hypertension in maintenance peritoneal dialysis patients, and provide an evidence for precise prevention and treatment of nocturnal hypertension in maintenance peritoneal dialysis patients.
- Conditions
- Hypertension,Nephropathy
- Being tested
- Losartan
- Keywords
- Nocturnal hypertension,Peritoneal dialysis,Losartan
- Medical subject headings
- Hypertensive Nephropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LosartanDrug
Also called Cozaar
Participants will be divided into 2 groups as daytime group and nighttime group The participants in daytime group will take 100-200mg Losartan in the morning between 6AM to 8AM. The participants in nighttime group will take 100-200mg Losartan at night between 9PM to 11PM .
| Study group | Role | What they receive |
|---|---|---|
| nighttime group | Experimental | patients with nocturnal hypertension taking losartan at nighttime Receives: Drug: Losartan |
| daytime group | Active comparator | patients with nocturnal hypertension taking losartan at daytime Receives: Drug: Losartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
all-cause mortality
Rate of death caused by all causes
Measured: 5 years
Secondary outcomes (3)
cardiovascular mortality
Rate of death caused by cardiovascular events, such as myocardial infarction,arrythmia and heart failure
Measured: 5 years
cerebrovascular mortality
Rate of death caused by cerebral vascular events, such as stroke
Measured: 5 years
incidence of cardiocerebral vascular events
Incidence of cardiovascular and cerebrovascular events that require hospitalization and lead to death or non death, including myocardial infarction, heart failure, stroke,vascular reconstruction,peripheral vascular disease, and non-traumatic amputation
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2018
- Study start1 Dec 2018 (estimated)
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Hypertension,NephropathyStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fifth Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Third Affiliated Hospital, Sun Yat-Sen University
- Responsible party
- Principal investigator, Cheng Wang, Fifth Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Cheng Wang, Director, Principal investigator, Nephrology Department, the Fifth Affiliated Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03692013
- Sponsor's protocol ID
- Losartan
- Status last verified
- Nov 2018
- First submitted
- 29 Sep 2018
- Last updated
- 5 Nov 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jager KJ, Merkus MP, Dekker FW, Boeschoten EW, Tijssen JG, Stevens P, Bos WJ, Krediet RT. Mortality and technique failure in patients starting chronic peritoneal dialysis: results of The Netherlands Cooperative Study on the Adequacy of Dialysis. NECOSAD Study Group. Kidney Int. 1999 Apr;55(4):1476-85. doi: 10.1046/j.1523-1755.1999.00353.x.
PubMed 10201013Udayaraj UP, Steenkamp R, Caskey FJ, Rogers C, Nitsch D, Ansell D, Tomson CR. Blood pressure and mortality risk on peritoneal dialysis. Am J Kidney Dis. 2009 Jan;53(1):70-8. doi: 10.1053/j.ajkd.2008.08.030. Epub 2008 Nov 22.
PubMed 19027213Foley RN, Parfrey PS. Cardiovascular disease and mortality in ESRD. J Nephrol. 1998 Sep-Oct;11(5):239-45.
PubMed 9831236Cocchi R, Degli Esposti E, Fabbri A, Lucatello A, Sturani A, Quarello F, Boero R, Bruno M, Dadone C, Favazza A, Scanziani R, Tommasi A, Giangrande A. Prevalence of hypertension in patients on peritoneal dialysis: results of an Italian multicentre study. Nephrol Dial Transplant. 1999 Jun;14(6):1536-40. doi: 10.1093/ndt/14.6.1536.
PubMed 10383021Menon MK, Naimark DM, Bargman JM, Vas SI, Oreopoulos DG. Long-term blood pressure control in a cohort of peritoneal dialysis patients and its association with residual renal function. Nephrol Dial Transplant. 2001 Nov;16(11):2207-13. doi: 10.1093/ndt/16.11.2207.
PubMed 11682669Buckalew VM Jr, Berg RL, Wang SR, Porush JG, Rauch S, Schulman G. Prevalence of hypertension in 1,795 subjects with chronic renal disease: the modification of diet in renal disease study baseline cohort. Modification of Diet in Renal Disease Study Group. Am J Kidney Dis. 1996 Dec;28(6):811-21. doi: 10.1016/s0272-6386(96)90380-7.
PubMed 8957032Mancia G, Fagard R, Narkiewicz K, Redon J, Zanchetti A, Bohm M, Christiaens T, Cifkova R, De Backer G, Dominiczak A, Galderisi M, Grobbee DE, Jaarsma T, Kirchhof P, Kjeldsen SE, Laurent S, Manolis AJ, Nilsson PM, Ruilope LM, Schmieder RE, Sirnes PA, Sleight P, Viigimaa M, Waeber B, Zannad F; Task Force for the Management of Arterial Hypertension of the European Society of Hypertension and the European Society of Cardiology. 2013 ESH/ESC Practice Guidelines for the Management of Arterial Hypertension. Blood Press. 2014 Feb;23(1):3-16. doi: 10.3109/08037051.2014.868629. Epub 2013 Dec 20. No abstract available.
PubMed 24359485Hodgkinson J, Mant J, Martin U, Guo B, Hobbs FD, Deeks JJ, Heneghan C, Roberts N, McManus RJ. Relative effectiveness of clinic and home blood pressure monitoring compared with ambulatory blood pressure monitoring in diagnosis of hypertension: systematic review. BMJ. 2011 Jun 24;342:d3621. doi: 10.1136/bmj.d3621.
PubMed 21705406Parati G, Ochoa JE, Salvi P, Lombardi C, Bilo G. Prognostic value of blood pressure variability and average blood pressure levels in patients with hypertension and diabetes. Diabetes Care. 2013 Aug;36 Suppl 2(Suppl 2):S312-24. doi: 10.2337/dcS13-2043. No abstract available.
PubMed 23882065Mancia G, Zanchetti A, Agabiti-Rosei E, Benemio G, De Cesaris R, Fogari R, Pessina A, Porcellati C, Rappelli A, Salvetti A, Trimarco B. Ambulatory blood pressure is superior to clinic blood pressure in predicting treatment-induced regression of left ventricular hypertrophy. SAMPLE Study Group. Study on Ambulatory Monitoring of Blood Pressure and Lisinopril Evaluation. Circulation. 1997 Mar 18;95(6):1464-70. doi: 10.1161/01.cir.95.6.1464.
PubMed 9118514Cuspidi C, Sala C, Valerio C, Negri F, Mancia G. Nocturnal blood pressure in untreated essential hypertensives. Blood Press. 2011 Dec;20(6):335-41. doi: 10.3109/08037051.2011.587280. Epub 2011 Jun 9.
PubMed 21651423Hoshide S, Ishikawa J, Eguchi K, Ojima T, Shimada K, Kario K. Masked nocturnal hypertension and target organ damage in hypertensives with well-controlled self-measured home blood pressure. Hypertens Res. 2007 Feb;30(2):143-9. doi: 10.1291/hypres.30.143.
PubMed 17460384Yano Y, Kario K. Nocturnal blood pressure and cardiovascular disease: a review of recent advances. Hypertens Res. 2012 Jul;35(7):695-701. doi: 10.1038/hr.2012.26. Epub 2012 Mar 1.
PubMed 22378470Clement DL, De Buyzere ML, De Bacquer DA, de Leeuw PW, Duprez DA, Fagard RH, Gheeraert PJ, Missault LH, Braun JJ, Six RO, Van Der Niepen P, O'Brien E; Office versus Ambulatory Pressure Study Investigators. Prognostic value of ambulatory blood-pressure recordings in patients with treated hypertension. N Engl J Med. 2003 Jun 12;348(24):2407-15. doi: 10.1056/NEJMoa022273.
PubMed 12802026Hansen TW, Li Y, Boggia J, Thijs L, Richart T, Staessen JA. Predictive role of the nighttime blood pressure. Hypertension. 2011 Jan;57(1):3-10. doi: 10.1161/HYPERTENSIONAHA.109.133900. Epub 2010 Nov 15.
PubMed 21079049
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Nighttime Losartan on Prognosis of Nocturnal Hypertension Patients Undergoing Continous Ambulatory Peritoneal Dialysis
- ClinicalTrials.gov ID
- NCT03692013
- Acronym / sponsor ID
- Losartan
- Conditions
- Hypertension,Nephropathy
- Keywords
- Nocturnal hypertension,Peritoneal dialysis,Losartan
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Fifth Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Collaborators
- Third Affiliated Hospital, Sun Yat-Sen University
- Study start
- 1 Dec 2018 (estimated)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 2 Oct 2018 (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.
Hypertension is one of the most important independent risk factors for the prognosis of continous ambulatory peritoneal dialysis patients. The incident rate is high and the control rate is low. Nocturnal hypertension has been paid more attention in recent years. Compared to daytime blood pressure, nocturnal blood pressure is an independent and efficient prognostic indicator of hypertensive deaths and cardiovascular events, but it is lack of evidence about its impact on prognosis in peritoneal dialysis patients and the effective treatment program. Our previous cohort study suggests that the incidence of nocturnal hypertension in patients with chronic kidney disease is up to 71.22%, with a significant increase as the decline of renal function, and more severe target organ damage in patients with nocturnal hypertension: the decrease of glomerular filtration rate, left ventricular hypertrophy, and the increase of all cause death and cardiovascular death. Our small sample size study show that night time antihypertensive drugs can better control blood pressure and delay the development of left ventricular hypertrophy. These preliminary results suggest that nocturnal hypertension is closely related to the prognosis of chronic renal disease. Taking antihypertensive drugs at night is one of the options for controlling nocturnal hypertension. However, it is not clear whether taking antihypertensive drugs at night can improve the prognosis of maintenance peritoneal dialysis patients with nocturnal hypertension. To this end, the investigators collect continous ambulatory peritoneal dialysis patients with nocturnal hypertension, and propose a time selective use of losartan to intervene in nocturnal hypertension. By comparing the difference in the effects of losartan on the prognosis of maintenance peritoneal dialysis patients during the day or night, to further clarify the role of nocturnal hypertension in the prognosis of maintenance peritoneal dialysis patients, whether controlling nocturnal hypertension can improve the prognosis of maintenance peritoneal dialysis patients. The completion of study will optimize the prevention and treatment of hypertension in maintenance peritoneal dialysis patients, and provide an evidence for precise prevention and treatment of nocturnal hypertension in maintenance peritoneal dialysis patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nighttime group | Experimental | Drug: Losartanpatients with nocturnal hypertension taking losartan at nighttime |
| daytime group | Active comparator | Drug: Losartanpatients with nocturnal hypertension taking losartan at daytime |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age over 18 years old and <75 years.
- Diagnosed as chronic kidney disease 5th stage in accordance with the KDIGO guide 2012 (egfr < 15 ml/ (min 1.73m2)).
- Accept 3-5 bags daily, continous ambulatory peritoneal dialysis for >3 months.
- Ambulatory blood pressure monitoring indicates nighttime systolic blood pressure (SBP) > 120mmHg and / or diastolic blood pressure (DBP) > 70mmHg.
Key exclusion criteria (12 listed)
- Night learning or work, irregular rest for a long time.
- Moderate and severe edema in difficult to correct
- Persistent atrial fibrillation.
- Severe anemia and severe dystrophy.
- Patients with postural hypotension or symptomatic hypotension.
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 |
|---|---|---|
| LosartanAlso: CozaarParticipants will be divided into 2 groups as daytime group and nighttime group The participants in daytime group will take 100-200mg Losartan in the morning between 6AM to 8AM. The participants in nighttime group will take 100-200mg Losartan at night between 9PM to 11PM . | Drug | daytime group, nighttime group |
Primary outcome
all-cause mortality
Time frame: 5 years
Rate of death caused by all causes
3 secondary outcomes
cardiovascular mortality
Time frame: 5 years
cerebrovascular mortality
Time frame: 5 years
incidence of cardiocerebral vascular events
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2018.
- Background: PubMed 10201013Jager KJ, Merkus MP, Dekker FW, Boeschoten EW, Tijssen JG, Stevens P, Bos WJ, Krediet RT. Mortality and technique failure in patients starting chronic peritoneal dialysis: results of The Netherlands Cooperative Study on the Adequacy of Dialysis. NECOSAD Study Group. Kidney Int. 1999 Apr;55(4):1476-85. doi: 10.1046/j.1523-1755.1999.00353.x.
- Background: PubMed 19027213Udayaraj UP, Steenkamp R, Caskey FJ, Rogers C, Nitsch D, Ansell D, Tomson CR. Blood pressure and mortality risk on peritoneal dialysis. Am J Kidney Dis. 2009 Jan;53(1):70-8. doi: 10.1053/j.ajkd.2008.08.030. Epub 2008 Nov 22.
- Background: PubMed 9831236Foley RN, Parfrey PS. Cardiovascular disease and mortality in ESRD. J Nephrol. 1998 Sep-Oct;11(5):239-45.
- Background: PubMed 10383021Cocchi R, Degli Esposti E, Fabbri A, Lucatello A, Sturani A, Quarello F, Boero R, Bruno M, Dadone C, Favazza A, Scanziani R, Tommasi A, Giangrande A. Prevalence of hypertension in patients on peritoneal dialysis: results of an Italian multicentre study. Nephrol Dial Transplant. 1999 Jun;14(6):1536-40. doi: 10.1093/ndt/14.6.1536.
- Background: PubMed 11682669Menon MK, Naimark DM, Bargman JM, Vas SI, Oreopoulos DG. Long-term blood pressure control in a cohort of peritoneal dialysis patients and its association with residual renal function. Nephrol Dial Transplant. 2001 Nov;16(11):2207-13. doi: 10.1093/ndt/16.11.2207.
- Background: PubMed 8957032Buckalew VM Jr, Berg RL, Wang SR, Porush JG, Rauch S, Schulman G. Prevalence of hypertension in 1,795 subjects with chronic renal disease: the modification of diet in renal disease study baseline cohort. Modification of Diet in Renal Disease Study Group. Am J Kidney Dis. 1996 Dec;28(6):811-21. doi: 10.1016/s0272-6386(96)90380-7.
- Background: PubMed 24359485Mancia G, Fagard R, Narkiewicz K, Redon J, Zanchetti A, Bohm M, Christiaens T, Cifkova R, De Backer G, Dominiczak A, Galderisi M, Grobbee DE, Jaarsma T, Kirchhof P, Kjeldsen SE, Laurent S, Manolis AJ, Nilsson PM, Ruilope LM, Schmieder RE, Sirnes PA, Sleight P, Viigimaa M, Waeber B, Zannad F; Task Force for the Management of Arterial Hypertension of the European Society of Hypertension and the European Society of Cardiology. 2013 ESH/ESC Practice Guidelines for the Management of Arterial Hypertension. Blood Press. 2014 Feb;23(1):3-16. doi: 10.3109/08037051.2014.868629. Epub 2013 Dec 20. No abstract available.
- Background: PubMed 21705406Hodgkinson J, Mant J, Martin U, Guo B, Hobbs FD, Deeks JJ, Heneghan C, Roberts N, McManus RJ. Relative effectiveness of clinic and home blood pressure monitoring compared with ambulatory blood pressure monitoring in diagnosis of hypertension: systematic review. BMJ. 2011 Jun 24;342:d3621. doi: 10.1136/bmj.d3621.
- Background: PubMed 23882065Parati G, Ochoa JE, Salvi P, Lombardi C, Bilo G. Prognostic value of blood pressure variability and average blood pressure levels in patients with hypertension and diabetes. Diabetes Care. 2013 Aug;36 Suppl 2(Suppl 2):S312-24. doi: 10.2337/dcS13-2043. No abstract available.
- Background: PubMed 9118514Mancia G, Zanchetti A, Agabiti-Rosei E, Benemio G, De Cesaris R, Fogari R, Pessina A, Porcellati C, Rappelli A, Salvetti A, Trimarco B. Ambulatory blood pressure is superior to clinic blood pressure in predicting treatment-induced regression of left ventricular hypertrophy. SAMPLE Study Group. Study on Ambulatory Monitoring of Blood Pressure and Lisinopril Evaluation. Circulation. 1997 Mar 18;95(6):1464-70. doi: 10.1161/01.cir.95.6.1464.
- Background: PubMed 21651423Cuspidi C, Sala C, Valerio C, Negri F, Mancia G. Nocturnal blood pressure in untreated essential hypertensives. Blood Press. 2011 Dec;20(6):335-41. doi: 10.3109/08037051.2011.587280. Epub 2011 Jun 9.
- Background: PubMed 17460384Hoshide S, Ishikawa J, Eguchi K, Ojima T, Shimada K, Kario K. Masked nocturnal hypertension and target organ damage in hypertensives with well-controlled self-measured home blood pressure. Hypertens Res. 2007 Feb;30(2):143-9. doi: 10.1291/hypres.30.143.
- 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.
Cheng Wang, Director principal investigator
Nephrology Department, the Fifth Affiliated Hospital of Sun Yat-Sen University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Losartan in people with Hypertension,Nephropathy, run by Fifth Affiliated Hospital, Sun Yat-Sen University.
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 4 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 5 Nov 2018. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lin Lin, Doctor (0086 756 2528701, 861282392@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
all-cause mortality (time frame: 5 years). 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 NCT03692013, which also lists 19 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 5 Nov 2018.