Heart FailureNCT03461107
Evaluation of Clinical and Genetic Modifiers of Long-term Survival in Heart Failure
An observational study of Heart Failure, run by Tongji Hospital at 1 site in China.
Trial summary
The purpose of this study is to evaluate the beta-adrenergic receptor gene polymorphisms in the long-term effects of beta-blockade in patients with chronic heart failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- How many people
- 2,500 participants
- Where
- 1 siteChina
- Study dates
- 18 Apr 2016to 31 Dec 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: 2500 outpatients or hospitalized patients with chronic heart failure will be enrolled in this study.
Who may be able to join
- 18 years of age or older;
- Patients are required to have chronic heart failure (NYHA II-IV) with a left ventricular ejection fraction lower than 40%;
- Patients are voluntary and signed informed consent.
Who cannot join
- Pregnant women or plan to;
- Participate in any drug clinical trials within 3 months;
- Serious neurological disease (Alzheimer's disease, Parkinson syndrome, progressive lower limbs or deaf patients);
- Previous history of cancer or tumor, or pathological examination confirmed precancerous lesions;
- Patients refused to comply with the requirements of this study to complete the research work;
- According to the researchers, patients can not complete the study or not to comply with the requirements of this study (because of the reasons for the management or other reasons).
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital
Wuhan, Hubei, 430030
Li Ni, Doctor, 86-27-83663280, nili@tjh.tjmu.edu.cn
About this study
Official title: Evaluation of Beta-adrenergic Receptor Gene Polymorphisms in the Long-term Effects of Beta-blockade in Patients With Chronic Heart Failure
The purpose of this study is to evaluate the beta-adrenergic receptor gene polymorphisms in the long-term effects of beta-blockade in patients with chronic heart failure.
- Conditions
- Heart Failure
- Being tested
- No intervention
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
| Study group | Role | What they receive |
|---|---|---|
| patients with heart failure | Not described Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular death
Measured: up to 24 months
Heart transplantation
Measured: up to 24 months
Secondary outcomes (3)
All cause death
Measured: up to 24 months
Heart failure recuring
Measured: up to 24 months
Readmission because of cardiovascular diseases
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2018
- Study start18 Apr 2016
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- 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
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dao Wen Wang, Tongji Hospital
- Investigators
- Dao Wen Wang, doctor, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03461107
- Sponsor's protocol ID
- TJ-HF-ARB
- Status last verified
- Apr 2019
- First submitted
- 5 Mar 2018
- Last updated
- 10 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhao C, Jiang X, Peng L, Zhang Y, Li H, Zhang Q, Wang Y, Yang F, Wu J, Wen Z, He Z, Shen J, Chen C, Wang DW. Glimepiride, a novel soluble epoxide hydrolase inhibitor, protects against heart failure via increasing epoxyeicosatrienoic acids. J Mol Cell Cardiol. 2023 Dec;185:13-25. doi: 10.1016/j.yjmcc.2023.10.009. Epub 2023 Oct 21.
PubMed 37871528Zhao Y, Li H, Du H, Yin Z, He M, Fan J, Nie X, Sun Y, Hou H, Dai B, Zhang X, Cai Y, Jin K, Ding N, Wen Z, Chang J, Chen C, Wang DW. A Kaposi's sarcoma-associated herpes virus-encoded microRNA contributes to dilated cardiomyopathy. Signal Transduct Target Ther. 2023 Jun 9;8(1):226. doi: 10.1038/s41392-023-01434-3.
PubMed 37291118Peng L, Song Z, Zhao C, Abuduwufuer K, Wang Y, Wen Z, Ni L, Li C, Yu Y, Zhu Y, Jiang H, Shen J, Jiang X, Chen C, Zhang X, Wang DW. Increased Soluble Epoxide Hydrolase Activity Positively Correlates with Mortality in Heart Failure Patients with Preserved Ejection Fraction: Evidence from Metabolomics. Phenomics. 2022 Oct 27;3(1):34-49. doi: 10.1007/s43657-022-00069-8. eCollection 2023 Feb.
PubMed 36939801Wei H, Zhao M, Wu J, Li C, Huang M, Gao J, Zhang Q, Ji L, Wang Y, Zhao C, Dong E, Zheng L, Wang DW. Association of Systemic Trimethyllysine With Heart Failure With Preserved Ejection Fraction and Cardiovascular Events. J Clin Endocrinol Metab. 2022 Nov 25;107(12):e4360-e4370. doi: 10.1210/clinem/dgac519.
PubMed 36062477Hu D, Xiao L, Li S, Hu S, Sun Y, Wang Y, Wang DW. Prediction of HF-Related Mortality Risk Using Genetic Risk Score Alone and in Combination With Traditional Risk Factors. Front Cardiovasc Med. 2021 Apr 26;8:634966. doi: 10.3389/fcvm.2021.634966. eCollection 2021.
PubMed 33981732Hu D, Li S, Hu S, Sun Y, Xiao L, Li C, Wang J, Wang Y, Ni L, Zhao C, Wang DW. A Common Missense Variant in OMA1 Associated with the Prognosis of Heart Failure. Cardiovasc Drugs Ther. 2020 Jun;34(3):345-356. doi: 10.1007/s10557-020-06960-8.
PubMed 32236861Hu D, Huang J, Hu S, Zhang Y, Li S, Sun Y, Li C, Cui G, Wang DW. A common variant of RIP3 promoter region is associated with poor prognosis in heart failure patients by influencing SOX17 binding. J Cell Mol Med. 2019 Aug;23(8):5317-5328. doi: 10.1111/jcmm.14408. Epub 2019 May 31.
PubMed 31148336
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Beta-adrenergic Receptor Gene Polymorphisms in the Long-term Effects of Beta-blockade in Patients With Chronic Heart Failure
- ClinicalTrials.gov ID
- NCT03461107
- Acronym / sponsor ID
- TJ-HF-ARB
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 18 Apr 2016 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 9 Mar 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.
The purpose of this study is to evaluate the beta-adrenergic receptor gene polymorphisms in the long-term effects of beta-blockade in patients with chronic heart failure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with heart failure | – | Other: No intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 2500 outpatients or hospitalized patients with chronic heart failure will be enrolled in this study.
Key inclusion criteria (3 listed)
- 18 years of age or older;
- Patients are required to have chronic heart failure (NYHA II-IV) with a left ventricular ejection fraction lower than 40%;
- Patients are voluntary and signed informed consent.
Key exclusion criteria (6 listed)
- Pregnant women or plan to;
- Participate in any drug clinical trials within 3 months;
- Serious neurological disease (Alzheimer's disease, Parkinson syndrome, progressive lower limbs or deaf patients);
- Previous history of cancer or tumor, or pathological examination confirmed precancerous lesions;
- Patients refused to comply with the requirements of this study to complete the research work;
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 |
|---|---|---|
| No intervention | Other | patients with heart failure |
Primary outcome
Cardiovascular death
Time frame: up to 24 months
Heart transplantation
Time frame: up to 24 months
3 secondary outcomes
All cause death
Time frame: up to 24 months
Heart failure recuring
Time frame: up to 24 months
Readmission because of cardiovascular diseases
Time frame: up to 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2019.
- Derived from this study: PubMed 37871528Zhao C, Jiang X, Peng L, Zhang Y, Li H, Zhang Q, Wang Y, Yang F, Wu J, Wen Z, He Z, Shen J, Chen C, Wang DW. Glimepiride, a novel soluble epoxide hydrolase inhibitor, protects against heart failure via increasing epoxyeicosatrienoic acids. J Mol Cell Cardiol. 2023 Dec;185:13-25. doi: 10.1016/j.yjmcc.2023.10.009. Epub 2023 Oct 21.
- Derived from this study: PubMed 37291118Zhao Y, Li H, Du H, Yin Z, He M, Fan J, Nie X, Sun Y, Hou H, Dai B, Zhang X, Cai Y, Jin K, Ding N, Wen Z, Chang J, Chen C, Wang DW. A Kaposi's sarcoma-associated herpes virus-encoded microRNA contributes to dilated cardiomyopathy. Signal Transduct Target Ther. 2023 Jun 9;8(1):226. doi: 10.1038/s41392-023-01434-3.
- Derived from this study: PubMed 36939801Peng L, Song Z, Zhao C, Abuduwufuer K, Wang Y, Wen Z, Ni L, Li C, Yu Y, Zhu Y, Jiang H, Shen J, Jiang X, Chen C, Zhang X, Wang DW. Increased Soluble Epoxide Hydrolase Activity Positively Correlates with Mortality in Heart Failure Patients with Preserved Ejection Fraction: Evidence from Metabolomics. Phenomics. 2022 Oct 27;3(1):34-49. doi: 10.1007/s43657-022-00069-8. eCollection 2023 Feb.
- Derived from this study: PubMed 36062477Wei H, Zhao M, Wu J, Li C, Huang M, Gao J, Zhang Q, Ji L, Wang Y, Zhao C, Dong E, Zheng L, Wang DW. Association of Systemic Trimethyllysine With Heart Failure With Preserved Ejection Fraction and Cardiovascular Events. J Clin Endocrinol Metab. 2022 Nov 25;107(12):e4360-e4370. doi: 10.1210/clinem/dgac519.
- Derived from this study: PubMed 33981732Hu D, Xiao L, Li S, Hu S, Sun Y, Wang Y, Wang DW. Prediction of HF-Related Mortality Risk Using Genetic Risk Score Alone and in Combination With Traditional Risk Factors. Front Cardiovasc Med. 2021 Apr 26;8:634966. doi: 10.3389/fcvm.2021.634966. eCollection 2021.
- Derived from this study: PubMed 32236861Hu D, Li S, Hu S, Sun Y, Xiao L, Li C, Wang J, Wang Y, Ni L, Zhao C, Wang DW. A Common Missense Variant in OMA1 Associated with the Prognosis of Heart Failure. Cardiovasc Drugs Ther. 2020 Jun;34(3):345-356. doi: 10.1007/s10557-020-06960-8.
- Derived from this study: PubMed 31148336Hu D, Huang J, Hu S, Zhang Y, Li S, Sun Y, Li C, Cui G, Wang DW. A common variant of RIP3 promoter region is associated with poor prognosis in heart failure patients by influencing SOX17 binding. J Cell Mol Med. 2019 Aug;23(8):5317-5328. doi: 10.1111/jcmm.14408. Epub 2019 May 31.
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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.
Dao Wen Wang, doctor principal investigator
Tongji Hospital
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 Heart Failure, run by Tongji Hospital at 1 site in China.
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 3 inclusion and 6 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 10 Apr 2019. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Li Ni, doctor (86-27-83663280, nili@tjh.tjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular death (time frame: up to 24 months). 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 NCT03461107, which also lists 7 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 Apr 2019.