Diagnostic, Risk Stratification and Prognostic Value of Novel Biomarkers in Patients With Heart Failure
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|ClinicalTrials.gov Identifier: NCT03727828|
Recruitment Status : Not yet recruiting
First Posted : November 1, 2018
Last Update Posted : November 1, 2018
|Condition or disease||Intervention/treatment|
|Heart Failure||Diagnostic Test: Patients with heart failure|
|Study Type :||Observational|
|Estimated Enrollment :||3000 participants|
|Official Title:||Diagnostic, Risk Stratification and Prognostic Value of Novel Biomarkers in Patients With Heart Failure: DRAGON-HF Study|
|Estimated Study Start Date :||November 15, 2018|
|Estimated Primary Completion Date :||December 1, 2020|
|Estimated Study Completion Date :||February 28, 2021|
Patients with heart failure
Patients with heart failure (HF) who are followed in the hospital or clinic setting, with optimization of medical therapy and blood collection.
Diagnostic Test: Patients with heart failure
Participants will have serial blood collection on medical therapy for heart failure
- Number of participants with cardiaovascular death after 5-year follow up [ Time Frame: 5 years ]The cardiovascular mortality after 5-year follow up will be assessed to detect prognostic values of circulating biomarkers
- Time to decompensated heart failure (HF) requiring in-patient admission or ER visit or IV diuretic therapy in the outpatient realm [ Time Frame: 5 years ]New onset of classic symptoms and signs of destabilized HF, including lower extremity edema, jugular venous distension, bibasilar crackles, orthopnea and paroxysmal nocturnal dyspnea.
- Comparison of new biomarker with NT-ProBNP on diagnostic value in patients with heart failure [ Time Frame: 1 year ]Compare the sensitivity and specificity of new biomarker with NT-ProBNP to assess the accuracy of diagnostic value in discriminating heart failure from non-heart failure participants.
- Change From Baseline in left ventricular ejection fraction [ Time Frame: 5 years ]Assess the change in left ventricular ejection fraction at the end of 5-year follow up.
- Change From Baseline in left ventricular end-systolic volume [ Time Frame: 5 years ]Assess the change in left ventricular end-systolic volume at the end of 5-year follow up.
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03727828
|Contact: Dachun Xu, Ph.Demail@example.com|
|Contact: Yuxi Sun, Ph.Dfirstname.lastname@example.org|
|Shanghai Tenth People's Hospital, Tongji University|
|Shanghai, Shanghai, China, 200072|
|Principal Investigator:||Dachun Xu, Ph.D||Shanghai 10th People's Hospital|