Chronic Heart FailureNCT02776384
Prognostic and Diagnostic Value of Biomarkers and Cardiac Functional Parameters in Patients With Chronic Heart Failure
An observational study of Chronic Heart Failure, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
The study aims to investigate whether disease progression in patients with chronic heart failure (CHF) can be assessed by new biomarkers, and determine their diagnostic value. The study also intends to describe comparison of echocardiography with cardiopulmonary function test in CHF patients, and relating these… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Heart Failure
- What is being tested?
- Observational study
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- Dec 2015to Dec 2025
- How long will I take part?
- 10 Years
- 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: patients who are diagnosed with chronic heart failure with either preserved or reduced ejection fraction in NYHA Ⅱ~Ⅳ
Who may be able to join
- Age ≥18 years
- with symptoms and signs in NYHA Ⅱ~Ⅳ
- with cardiac structural changes confirmed by echocardiography
Who cannot join
- with other severe diseases combined and will be alive for less than 12 months
- hard to participate in the investigation or accept the follow-up visits
- pregnant or lactating women
- during the acute phase of ST-elevation acute myocardial infarction, stroke, severe infection and other critical conditions
Trial locations and contacts
1 site in 1 country.
Rong Tao, Doctor contact
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200025
Rong Tao, rongtao@hotmail.com
Rong Tao
About this study
Official title: Prognostic and Diagnostic Value of Serial Biomarker Measurements, Echocardiographic Techniques and Cardiopulmonary Function Tests in Patients With Chronic Heart Failure.
The study aims to investigate whether disease progression in patients with chronic heart failure (CHF) can be assessed by new biomarkers, and determine their diagnostic value. The study also intends to describe comparison of echocardiography with cardiopulmonary function test in CHF patients, and relating these cardiac functional parameters to clinical outcome.
- Conditions
- Chronic Heart Failure
- Being tested
- Observational study
- Keywords
- Heart Failure, Biomarkers, Echocardiography, Cardiopulmonary Function Tests
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational studyOther
Also called no intervention
| Study group | Role | What they receive |
|---|---|---|
| chronic heart failure | patients who are diagnosed with chronic heart failure with either preserved or reduced ejection fraction Receives: Other: Observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
main adverse cardiovascular and cerebrovascular events, MACCE
MACCE includes all-cause mortality, cardiovascular mortality, nonfatal myocardial infarction, nonfatal stroke, target lesion revascularization and HF rehospitalization
Measured: 10 years
cardiovascular mortality
Measured: 10 years
Secondary outcomes (6)
all-cause mortality
Measured: 10 years
new myocardial infarction
Measured: 10 years
new stroke
Measured: 10 years
heart failure rehospitalization
Measured: 10 years
quality of life
described in quality of life scores
Measured: 10 years
worsening of renal function
either an increase of 0.3 mg/dl in serum creatinine or a 20% decrease in eGFR compared with baseline
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2016 (estimated)
- Study startDec 2015
- Primary completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Heart FailureStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe 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
- 1,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhang Qi, MD, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02776384
- Sponsor's protocol ID
- RJH-20151127
- Status last verified
- May 2016
- First submitted
- 15 May 2016
- Last updated
- 18 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic and Diagnostic Value of Serial Biomarker Measurements, Echocardiographic Techniques and Cardiopulmonary Function Tests in Patients With Chronic Heart Failure.
- ClinicalTrials.gov ID
- NCT02776384
- Acronym / sponsor ID
- RJH-20151127
- Conditions
- Chronic Heart Failure
- Keywords
- Heart Failure, Biomarkers, Echocardiography, Cardiopulmonary Function Tests
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Dec 2025 (estimated)
- First posted
- 18 May 2016 (estimated)
- 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 study aims to investigate whether disease progression in patients with chronic heart failure (CHF) can be assessed by new biomarkers, and determine their diagnostic value. The study also intends to describe comparison of echocardiography with cardiopulmonary function test in CHF patients, and relating these cardiac functional parameters to clinical outcome.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| chronic heart failure | – | Other: Observational studypatients who are diagnosed with chronic heart failure with either preserved or reduced ejection fraction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients who are diagnosed with chronic heart failure with either preserved or reduced ejection fraction in NYHA Ⅱ~Ⅳ
Key inclusion criteria (3 listed)
- Age ≥18 years
- with symptoms and signs in NYHA Ⅱ~Ⅳ
- with cardiac structural changes confirmed by echocardiography
Key exclusion criteria (4 listed)
- with other severe diseases combined and will be alive for less than 12 months
- hard to participate in the investigation or accept the follow-up visits
- pregnant or lactating women
- during the acute phase of ST-elevation acute myocardial infarction, stroke, severe infection and other critical conditions
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 |
|---|---|---|
| Observational studyAlso: no intervention | Other | chronic heart failure |
Primary outcome
main adverse cardiovascular and cerebrovascular events, MACCE
Time frame: 10 years
MACCE includes all-cause mortality, cardiovascular mortality, nonfatal myocardial infarction, nonfatal stroke, target lesion revascularization and HF rehospitalization
cardiovascular mortality
Time frame: 10 years
6 secondary outcomes
all-cause mortality
Time frame: 10 years
new myocardial infarction
Time frame: 10 years
new stroke
Time frame: 10 years
heart failure rehospitalization
Time frame: 10 years
quality of life
Time frame: 10 years
worsening of renal function
Time frame: 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2016.
- Individual participant dataSharing planned: Undecided
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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.
Rong Tao, Doctor contact
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 Chronic Heart Failure, run by Shanghai Jiao Tong University School of Medicine 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 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: status not confirmed, as of the sponsor's last update on 18 May 2016. 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 Rong Tao, Doctor (rongtao@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
main adverse cardiovascular and cerebrovascular events, MACCE (time frame: 10 years). 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?
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 18 May 2016.