Chronic Heart FailureNCT02812797
Prognostic Value of Adipokine Levels of Patients With Chronic Heart Failure
An observational study of Chronic Heart Failure, run by Chongqing Medical University at 1 site in China.
Trial summary
The purpose of this study is to determine whether expressions of adipokines can provide prognostic information concerning patients with chronic heart failure. Read more about this study
- Who is it for?
- Ages 12 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Heart Failure
- How many people
- 98 participants
- Where
- 1 siteChina
- Study dates
- Jun 2016to Jan 2020
- How long will I take part?
- 1 Year
- 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 12 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients With Chronic Heart Failure
Who may be able to join
- Patients who are giving open chest surgical treatment with a history of chronic heart failure (NYHA II ~ IV) more than 6 months.
- Patients from whom informed consent has been properly obtained in writing prior to start of the trial.
Who cannot join
- Patients with concurrent infection or any documented inflammatory illness, such as arthritis or connective tissue diseases,or any other malignancy.
- Patients with a history of cardiomyopathy.
- Patients with Chronic arrhythmia.
- Pregnant women
- Severe hepatic dysfunction or End-stage renal failure.
- Uncontrolled hypertension.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400000
About this study
The purpose of this study is to determine whether expressions of adipokines can provide prognostic information concerning patients with chronic heart failure.
- Conditions
- Chronic Heart Failure
- Keywords
- Adipokines, Chronic Heart Failure, Prognosis
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
Measured: Change from Baseline at 3, 6 and 12 months
Secondary outcomes (5)
New York Heart Association (NYHA) Classification
Measured: Week:4
re-hospitalization
Heart failure with re-hospitalization is documented by at least one of the following: worse exercise tolerance and respiratory distress with NYHA class III or IV symptoms, presence of pulmonary rales, or chest radiography showing pulmonary congestion, which needs an augmented decongestive regimen with oral or intravenous medications during an in-hospital stay.
Measured: Change from Baseline at 3, 6 and 12 months
plasma brain natriuretic peptide (BNP) concentration
Measured: Week:4
Cardiovascular death
Measured: Change from Baseline at 3, 6 and 12 months
Cardiac transplantation
Measured: Change from Baseline at 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionAug 2019
- Study completionJan 2020
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.
- 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
- 98 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dongying Zhang, Chongqing Medical University
- Investigators
- Dongying Zhang, doctor, Study director, Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02812797
- Sponsor's protocol ID
- 2016-38-2
- Status last verified
- Mar 2020
- First submitted
- 20 Jun 2016
- Last updated
- 4 Mar 2020
- 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 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of Adipokine Levels of Patients With Chronic Heart Failure
- ClinicalTrials.gov ID
- NCT02812797
- Acronym / sponsor ID
- 2016-38-2
- Conditions
- Chronic Heart Failure
- Keywords
- Adipokines, Chronic Heart Failure, Prognosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Chongqing Medical UniversityUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- Aug 2019 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 24 Jun 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 purpose of this study is to determine whether expressions of adipokines can provide prognostic information concerning patients with chronic heart failure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 12 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients With Chronic Heart Failure
Key inclusion criteria (2 listed)
- Patients who are giving open chest surgical treatment with a history of chronic heart failure (NYHA II ~ IV) more than 6 months.
- Patients from whom informed consent has been properly obtained in writing prior to start of the trial.
Key exclusion criteria (6 listed)
- Patients with concurrent infection or any documented inflammatory illness, such as arthritis or connective tissue diseases,or any other malignancy.
- Patients with a history of cardiomyopathy.
- Patients with Chronic arrhythmia.
- Pregnant women
- Severe hepatic dysfunction or End-stage renal failure.
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
All-cause mortality
Time frame: Change from Baseline at 3, 6 and 12 months
5 secondary outcomes
New York Heart Association (NYHA) Classification
Time frame: Week:4
re-hospitalization
Time frame: Change from Baseline at 3, 6 and 12 months
plasma brain natriuretic peptide (BNP) concentration
Time frame: Week:4
Cardiovascular death
Time frame: Change from Baseline at 3, 6 and 12 months
Cardiac transplantation
Time frame: Change from Baseline at 3, 6 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Chronic Heart Failure
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
Not yet recruiting
Community Health Worker Nutrition Self-Management Support for Cardio-Kidney-Metabolic Health
Hypertension (HTN), CKD - Chronic Kidney Disease
RecruitingPhase 4
The Effects of Low-Dose Versus High-Dose Intravenous IRON Therapy With Ferric DerisomaltOSE in Patients With Chronic Heart Failure and Iron Deficiency
Heart Failure, Iron Deficiency
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
RecruitingObservational study
Norepinephrine in the Management of General Anesthesia-Induced Arterial Hypotension in Chronic Heart Failure Patients
Hypotension
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.
Dongying Zhang, doctor study director
Chongqing Medical University
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 Chongqing Medical University 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 2 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: finished, as of the sponsor's last update on 4 Mar 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (time frame: Change from Baseline at 3, 6 and 12 months). 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 4 Mar 2020.