Heart FailureNCT03797742
A Clinical Follow-up Study of Heart Failure Patients.
An observational study of Heart Failure, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
Heart failure (HF), a current worldwide pandemic with an unacceptable high level of morbidity and mortality, brings an enormous medical and societal burden. Chronic HF is characterized by progressive alteration of cardiac structure and function. Read more about this study
- Who is it for?
- Ages 15 to 80 years
- Conditions the study is for
- Heart Failure
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 1 Dec 2022
- 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 15 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The inpatient in the department of cardiology of Zhongshan Hospital, Fudan University will be selected.
Who may be able to join
- LVEF≤ 55%
- enlarged left ventricular end-diastolic dimension
- ICM group: with history of MI or revascularization; ≥ 75% stenosis of LM or proximal LAD; ≥ 75% stenosis of two or more epicardial vessels.
- symptomatic heart failure
Who cannot join
- Known malignant tumour diseases
- Pregnancy or lactation period；
- Investigators think not suitable to participate in this trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital
Shanghai
Zhangwei Chen, +8602164041990, chen.zhangwei@zs-hospital.sh.cn
About this study
Heart failure (HF), a current worldwide pandemic with an unacceptable high level of morbidity and mortality, brings an enormous medical and societal burden. Chronic HF is characterized by progressive alteration of cardiac structure and function. But the molecular mechanism of these alterations is still not well-established and needs to be discussed further. HF is a highly heterogeneous disease that can be caused by a multiple of diseases. Dilated cardiomyopathy (DCM) and ischemic cardiomyopathy (ICM) are the main causes of this syndrome. Although HF is the common manifestation of DCM and ICM, the etiology and pathogenesis are different. Understanding the different pathophysiological mechanisms will contribute to the prevention and individualized therapy of heart failure. Therefore, this study aims to observation the different characteristics of the molecular biology and clinical courses in DCM and ICM patients.
- Conditions
- Heart Failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| NC | Patients without heart failure. | |
| DCM | Dilated cardiomyopathy patients. | |
| ICM | Ischemic cardiomyopathy patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
NYHA functional class
NYHA cardiac functional class
Measured: one year after enrolled
All-cause mortality
All-cause mortality during follow-up
Measured: one year after enrolled
Secondary outcomes (3)
hospitalization for cardiac causes
hospitalization for cardiac causes during follow-up
Measured: one year after enrolled
left ventricular end-diastolic dimension(LVEDD) dilates.
left ventricular structure changes:left ventricular end-diastolic dimension(LVEDD) dilates.
Measured: one year after enrolled
left ventricular ejection fraction reduces
left ventricular function changes:left ventricular ejection fraction reduces
Measured: one year after enrolled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2019
- Study start1 Jan 2018
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03797742
- Sponsor's protocol ID
- HF201801
- Status last verified
- Jan 2019
- First submitted
- 1 Jan 2019
- Last updated
- 9 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Follow-up Study of Heart Failure Patients.
- ClinicalTrials.gov ID
- NCT03797742
- Acronym / sponsor ID
- HF201801
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 9 Jan 2019 (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.
Heart failure (HF), a current worldwide pandemic with an unacceptable high level of morbidity and mortality, brings an enormous medical and societal burden. Chronic HF is characterized by progressive alteration of cardiac structure and function. But the molecular mechanism of these alterations is still not well-established and needs to be discussed further. HF is a highly heterogeneous disease that can be caused by a multiple of diseases. Dilated cardiomyopathy (DCM) and ischemic cardiomyopathy (ICM) are the main causes of this syndrome. Although HF is the common manifestation of DCM and ICM, the etiology and pathogenesis are different. Understanding the different pathophysiological mechanisms will contribute to the prevention and individualized therapy of heart failure. Therefore, this study aims to observation the different characteristics of the molecular biology and clinical courses in DCM and ICM patients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NC | – | –Patients without heart failure. |
| DCM | – | –Dilated cardiomyopathy patients. |
| ICM | – | –Ischemic cardiomyopathy patients. |
Who may qualify
- Ages
- 15 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The inpatient in the department of cardiology of Zhongshan Hospital, Fudan University will be selected.
Key inclusion criteria (4 listed)
- LVEF≤ 55%
- enlarged left ventricular end-diastolic dimension
- ICM group: with history of MI or revascularization; ≥ 75% stenosis of LM or proximal LAD; ≥ 75% stenosis of two or more epicardial vessels.
- symptomatic heart failure
Key exclusion criteria (3 listed)
- Known malignant tumour diseases
- Pregnancy or lactation period；
- Investigators think not suitable to participate in this trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
NYHA functional class
Time frame: one year after enrolled
NYHA cardiac functional class
All-cause mortality
Time frame: one year after enrolled
All-cause mortality during follow-up
3 secondary outcomes
hospitalization for cardiac causes
Time frame: one year after enrolled
left ventricular end-diastolic dimension(LVEDD) dilates.
Time frame: one year after enrolled
left ventricular ejection fraction reduces
Time frame: one year after enrolled
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2019.
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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.
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 Shanghai Zhongshan 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 4 inclusion and 3 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 9 Jan 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 Zhangwei Chen (+86 021 64041990, chen.zhangwei@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NYHA functional class (time frame: one year after enrolled). 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 9 Jan 2019.