Acute Decompensated Heart FailureNCT04390919
Prognostic Factors of Patients With ADHF
An observational study of Acute Decompensated Heart Failure, run by Chongqing Medical University.
Trial summary
To explore the prognostic indicators for patients with ADHF Read more about this study
- Who is it for?
- Ages 18 to 94 years
- Conditions the study is for
- Acute Decompensated Heart Failure
- What is being tested?
- elevated monocyte count
- How many people
- 362 participants
- Where
- No sites listed yet
- Study dates
- 2 Aug 2011to 16 Feb 2015
- 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 to 94 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ADHF patient diagnosed in the department of cardiovascular medicine in the first affiliated hospital of chongqing medical university
Who may be able to join
- Patients with ADHF diagnosed according to ESC Guidelines for the diagnosis of acute heart failure 2008
Who cannot join
- disorders of the hematopoietic system, history of cancer and/or previous treatment with chemotherapy, the infection caused by various pathogens, chronic inflammatory conditions, glucocorticoid therapy and/or histories of glucocorticoid use 3 months before the admission and acute myocardial infarction or coronary revascularization within the past 6 months. Also, patients who did not have a differential WBC count or who were lost to follow-up were excluded.
About this study
Official title: Elevated Blood Monocyte Count Predicts 1 Year Poor Outcomes for Patients Admitted With Acute Decompensated Heart Failure
To explore the prognostic indicators for patients with ADHF
Read the detailed description
According to ESC Guidelines for the diagnosis of acute heart failure 2008, patients with ADHF were diagnosed, and their medical history, laboratory examination and treatment plan were retrospectively analyzed, and the patients were followed up for 1 year. The 1-year outcomes of patients were analyzed to explore the prognostic indicators for patients with ADHF
- Conditions
- Acute Decompensated Heart Failure
- Being tested
- elevated monocyte count
- Keywords
- monocyte count, heart failure, acute decompensated heart failure, all-cause death
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
elevated monocyte countOther
The monocyte count at admission was higher than 0.445×10*9 cells/L
| Study group | Role | What they receive |
|---|---|---|
| high group | high group: monocyte count≥0.445×10*9 cells/L Receives: Other: elevated monocyte count | |
| low group | low group: monocyte count<0.445×10*9 cells/L; |
What is being measured
The primary outcome is the main question the study is designed to answer.
all-cause death
The primary end point was one-year all-cause death
Measured: 1 year
Secondary outcomes (1)
HF-related rehospitalization
the secondary end point was one-year HF-related rehospitalization.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2020
- Study start2 Aug 2011
- Primary completion16 Feb 2015
- Study completion16 Feb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Decompensated 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
- Retrospective
- Enrolment
- 362 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dongying Zhang, Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04390919
- Sponsor's protocol ID
- 2020-05-04
- Status last verified
- May 2020
- First submitted
- 4 May 2020
- Last updated
- 18 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elevated Blood Monocyte Count Predicts 1 Year Poor Outcomes for Patients Admitted With Acute Decompensated Heart Failure
- ClinicalTrials.gov ID
- NCT04390919
- Acronym / sponsor ID
- 2020-05-04
- Conditions
- Acute Decompensated Heart Failure
- Keywords
- monocyte count, heart failure, acute decompensated heart failure, all-cause death
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 362 participants (actual)
- Lead sponsor
- Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 2 Aug 2011 (actual)
- Primary completion
- 16 Feb 2015 (actual)
- Study completion
- 16 Feb 2015 (actual)
- First posted
- 18 May 2020 (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.
To explore the prognostic indicators for patients with ADHF
Detailed description
According to ESC Guidelines for the diagnosis of acute heart failure 2008, patients with ADHF were diagnosed, and their medical history, laboratory examination and treatment plan were retrospectively analyzed, and the patients were followed up for 1 year. The 1-year outcomes of patients were analyzed to explore the prognostic indicators for patients with ADHF
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high group | – | Other: elevated monocyte counthigh group: monocyte count≥0.445×10*9 cells/L |
| low group | – | –low group: monocyte count<0.445×10*9 cells/L; |
Who may qualify
- Ages
- 18 to 94 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ADHF patient diagnosed in the department of cardiovascular medicine in the first affiliated hospital of chongqing medical university
Key inclusion criteria (1 listed)
- Patients with ADHF diagnosed according to ESC Guidelines for the diagnosis of acute heart failure 2008
Key exclusion criteria (1 listed)
- disorders of the hematopoietic system, history of cancer and/or previous treatment with chemotherapy, the infection caused by various pathogens, chronic inflammatory conditions, glucocorticoid therapy and/or histories of glucocorticoid use 3 months before the admission and acute myocardial infarction or coronary revascularization within the past 6 months. Also, patients who did not have a differential WBC count or who were lost to follow-up were excluded.
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 |
|---|---|---|
| elevated monocyte countThe monocyte count at admission was higher than 0.445×10*9 cells/L | Other | high group |
Primary outcome
all-cause death
Time frame: 1 year
The primary end point was one-year all-cause death
1 secondary outcome
HF-related rehospitalization
Time frame: 1 year
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 18 May 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Decompensated Heart Failure, run by Chongqing Medical University.
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 1 inclusion and 1 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 18 May 2020. Status can change between updates, so confirm with the study contact before making plans.
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 death (time frame: 1 year). 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 2020.