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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
Sponsor:
Collaborators:
Tongji Hospital
First Affiliated Hospital, Sun Yat-Sen University
Nanfang Hospital of Southern Medical University
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Fuwai Hospital
Yangpu Hospital
Shanghai Municipal Hospital of Traditional Chinese Medicine
Huashan Hospital Baoshan Branch
Shanghai Zhongye Hospital
Shanghai BaoshanLuodianHospital
Shanghai Shibei Hospital
Nantong Sixth People's Hospital
Information provided by (Responsible Party):
Ya-Wei Xu, Shanghai 10th People's Hospital

Brief Summary:
The objective of this work is to investigate and then to sequence new biomarkers in the blood of patients with heart failure, and study their diagnostic, risk stratification and prognostic value.

Condition or disease Intervention/treatment
Heart Failure Diagnostic Test: Patients with heart failure

Detailed Description:
Blood samples (plasma or serum) for heart failure patients presenting dyspnea or edema and with increased NT-proBNP. The objective of this work is to investigate and then to sequence new proteins or microRNAs in the blood of these patients for diagnostic, risk stratification and prognostic purpose.

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Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Group/Cohort Intervention/treatment
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

healthy control



Primary Outcome Measures :
  1. 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

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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
Peripheral blood collected at various time points according to the study cohort.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients with heart failure.Patients presenting with shortness of breathor edema and with increased NT-proBNP.
Criteria

Inclusion Criteria:

  1. Age > 18 years of age
  2. Symptomatic (NYHA class II-IV) heart failure (as diagnosed by clinician, radiographic images, or abnormal natriuretic peptide level)
  3. Hospital admission, Emergency Department visit, or outpatient diuretic escalation of therapy for destabilized HF at least once in the 6 months prior to enrollment

Exclusion Criteria:

  1. Life expectancy <1 year due to causes other than HF such as advanced cancer
  2. Cardiac transplantation or revascularization indicated or expected within 6 months
  3. Severe obstructive or restrictive pulmonary disease, defined as a forced expiratory volume in 1 sec <1 L (when diagnosed as standard of care)
  4. Subject unable or unwilling to provide written informed consent
  5. Coronary revascularization (percutaneous coronary intervention or bypass surgery) within the previous 3 months
  6. Progressive neurological disease
  7. Pregnancy

Information from the National Library of Medicine

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


Contacts
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Contact: Dachun Xu, Ph.D 0086-18917684045 xdc77@tongji.edu.cn
Contact: Yuxi Sun, Ph.D 0086-15216718171 sunyuxitj10h@163.com

Locations
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China, Shanghai
Shanghai Tenth People's Hospital, Tongji University
Shanghai, Shanghai, China, 200072
Sponsors and Collaborators
Shanghai 10th People's Hospital
Tongji Hospital
First Affiliated Hospital, Sun Yat-Sen University
Nanfang Hospital of Southern Medical University
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Fuwai Hospital
Yangpu Hospital
Shanghai Municipal Hospital of Traditional Chinese Medicine
Huashan Hospital Baoshan Branch
Shanghai Zhongye Hospital
Shanghai BaoshanLuodianHospital
Shanghai Shibei Hospital
Nantong Sixth People's Hospital
Investigators
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Principal Investigator: Dachun Xu, Ph.D Shanghai 10th People's Hospital

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Responsible Party: Ya-Wei Xu, Professor, Shanghai 10th People's Hospital
ClinicalTrials.gov Identifier: NCT03727828     History of Changes
Other Study ID Numbers: DRAGON-HF
First Posted: November 1, 2018    Key Record Dates
Last Update Posted: November 1, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: IPD will be available with reasonable request.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases