Heart Failure With Preserved Ejection FractionNCT05586828
A Single-center Retrospective Cohort Study to Explore the Prognostic Significance of CONUT in Elderly CAD Patients With HFpEFand Compare CONUT With Other Objective Nutritional Indices.
An observational study of Heart Failure With Preserved Ejection Fraction and Malnutrition, run by Beijing Tongren Hospital at 1 site in China.
Trial summary
HF is an advanced or terminal stage of various heart diseases, with high rehospitalization and mortality rates. In HF patients, undernutrition is not uncommon and represents one of the most significant determinants of poor clinical outcomes. Read more about this study
- Who is it for?
- Ages 65 to 99 years
- Conditions the study is for
- Heart Failure With Preserved Ejection Fraction, Malnutrition, Aged
- How many people
- 780 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2021to 31 May 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 65 to 99 years
- All sexes
- No healthy volunteers
- Older adult
Study population: elderly HFpEF Ⅱ-Ⅳ patients with coronary heart disease hospitalized in the Department of Geriatrics Medical Department of Beijing Tongren Hospital affiliated to Capital Medical University from January 1, 2017 to December 31, 2019 were selected
Who may be able to join
- Elderly patients (≧65years old) were accorded with diagnostic criteria of coronary artery disease, HFpEF and NYHA Ⅱ-Ⅳ
- Coronary artery disease was defined
- The diagnosis of HF was made according to the recommendations of the European Society of Cardiology .
- HFpEF was defined
- Severity of functional class was based on NYHA scale.
Who cannot join
- Rheumatic heart disease
- congenital heart disease
- acute myocardial infarction
- hemodialysis or hemofiltration
- tumour activity, urgent surgery
- death during hospitalization
Show all 10Show fewer
- HF of unknown reasons
- NYHA classⅠ
- data deficiency
- loss of follow-up
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality, 100730
About this study
Official title: A Single-center Retrospective Cohort Study to Explore the Prognostic Significance of CONUT in Elderly With HFpEF and Compare Controlling Nutritional Status Score With Other Objective Nutritional Indices. The Primary Endpoint of This Study Was Readmission Due to HF and All-cause Mortality in 1 Year After Hospitalization.
HF is an advanced or terminal stage of various heart diseases, with high rehospitalization and mortality rates. In HF patients, undernutrition is not uncommon and represents one of the most significant determinants of poor clinical outcomes. Therefore, nutritional management is of paramount importance for patients with HF.The basic method of nutritional management is to effectively identify the nutritional status of patients with heart failure, especially in elderly patients with heart failure who are not easy to find in the early stage. Limited data are available regarding the association between CONUT score and prognosis in elder patients with HFpEF, despite its easy availability in routine blood chemistry. Therefore, we aimed to evaluate the prognostic significance of CONUT score and to compare it with other well-established nutritional indices in HFpEF, a common HF phenotype in the elderly population with coronary artery disease.
This was a single-center retrospective cohort study which were approved by the Clinical Research Ethics Committee of our hospital (TRECKY2021-185). Written informed consent was obtained from all patients.
Participants were accorded with diagnostic criteria of CAD and HFpEF excluding rheumatic heart disease, congenital heart disease, acute myocardial infarction, hemodialysis or hemofiltration, tumour activity, urgent surgery, death during hospitalization, HF of unknown reasons, New York Heart Association(NYHA) class1and data deficiency. Demographic characteristics and medical parameters were collected from the electronic medical record system . All enrolled patients were followed-up in an outpatients setting. The primary endpoint of this study was readmission due to heart failure and all-cause mortality in the first year after hospitalization. To explore the prognostic significance of controlling nutritional status score in elderly with ejection fraction preserved heart failure and compare controlling nutritional status score with other objective nutritional indices.All analyses were performed using Statistical Product Service Solutions(SPSS) version 19.0 .
- Medical subject headings
- Malnutrition
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 |
|---|---|---|
| different controlling nutritional status score | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
readmission due to heart failure in the first year after hospitalization
Measured: up to one year
all-cause mortality in the first year after hospitalization
Measured: up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2022
- Study start1 Sep 2021
- Primary completion31 May 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart Failure With Preserved Ejection FractionStudies of the same condition, open and under way.
- More trials run by Beijing Tongren 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 780 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Tongren Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- YING CHEN, Chief Physician, Study chair, Beijing Tongren HospitalHUI ZHENG, M.D., Principal investigator, Beijing Tongren Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05586828
- Sponsor's protocol ID
- BeijingTH20210812chz1
- Status last verified
- May 2022
- First submitted
- 17 Oct 2022
- Last updated
- 20 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chen Y, Zheng H, He Y. Prognostic significance of controlling nutritional status in older adults with heart failure with preserved ejection fraction: a prospective comparative study with other objective nutritional indices. Aging Clin Exp Res. 2023 Jun;35(6):1305-1315. doi: 10.1007/s40520-023-02395-x. Epub 2023 Apr 1.
PubMed 37005959
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center Retrospective Cohort Study to Explore the Prognostic Significance of CONUT in Elderly With HFpEF and Compare Controlling Nutritional Status Score With Other Objective Nutritional Indices. The Primary Endpoint of This Study Was Readmission Due to HF and All-cause Mortality in 1 Year After Hospitalization.
- ClinicalTrials.gov ID
- NCT05586828
- Acronym / sponsor ID
- BeijingTH20210812chz1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 780 participants (actual)
- Lead sponsor
- Beijing Tongren HospitalUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 19 Oct 2022 (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.
HF is an advanced or terminal stage of various heart diseases, with high rehospitalization and mortality rates. In HF patients, undernutrition is not uncommon and represents one of the most significant determinants of poor clinical outcomes. Therefore, nutritional management is of paramount importance for patients with HF.The basic method of nutritional management is to effectively identify the nutritional status of patients with heart failure, especially in elderly patients with heart failure who are not easy to find in the early stage. Limited data are available regarding the association between CONUT score and prognosis in elder patients with HFpEF, despite its easy availability in routine blood chemistry. Therefore, we aimed to evaluate the prognostic significance of CONUT score and to compare it with other well-established nutritional indices in HFpEF, a common HF phenotype in the elderly population with coronary artery disease.
This was a single-center retrospective cohort study which were approved by the Clinical Research Ethics Committee of our hospital (TRECKY2021-185). Written informed consent was obtained from all patients.
Participants were accorded with diagnostic criteria of CAD and HFpEF excluding rheumatic heart disease, congenital heart disease, acute myocardial infarction, hemodialysis or hemofiltration, tumour activity, urgent surgery, death during hospitalization, HF of unknown reasons, New York Heart Association(NYHA) class1and data deficiency. Demographic characteristics and medical parameters were collected from the electronic medical record system . All enrolled patients were followed-up in an outpatients setting. The primary endpoint of this study was readmission due to heart failure and all-cause mortality in the first year after hospitalization. To explore the prognostic significance of controlling nutritional status score in elderly with ejection fraction preserved heart failure and compare controlling nutritional status score with other objective nutritional indices.All analyses were performed using Statistical Product Service Solutions(SPSS) version 19.0 .
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| different controlling nutritional status score | – | – |
Who may qualify
- Ages
- 65 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- elderly HFpEF Ⅱ-Ⅳ patients with coronary heart disease hospitalized in the Department of Geriatrics Medical Department of Beijing Tongren Hospital affiliated to Capital Medical University from January 1, 2017 to December 31, 2019 were selected
Key inclusion criteria (5 listed)
- Elderly patients (≧65years old) were accorded with diagnostic criteria of coronary artery disease, HFpEF and NYHA Ⅱ-Ⅳ
- Coronary artery disease was defined
- The diagnosis of HF was made according to the recommendations of the European Society of Cardiology .
- HFpEF was defined
- Severity of functional class was based on NYHA scale.
Key exclusion criteria (10 listed)
- Rheumatic heart disease
- congenital heart disease
- acute myocardial infarction
- hemodialysis or hemofiltration
- tumour activity, urgent surgery
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
readmission due to heart failure in the first year after hospitalization
Time frame: up to one year
all-cause mortality in the first year after hospitalization
Time frame: up to one 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 20 Apr 2023.
- Derived from this study: PubMed 37005959Chen Y, Zheng H, He Y. Prognostic significance of controlling nutritional status in older adults with heart failure with preserved ejection fraction: a prospective comparative study with other objective nutritional indices. Aging Clin Exp Res. 2023 Jun;35(6):1305-1315. doi: 10.1007/s40520-023-02395-x. Epub 2023 Apr 1.
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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.
YING CHEN, Chief Physician study chair
Beijing Tongren Hospital
HUI ZHENG, M.D. principal investigator
Beijing Tongren Hospital
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 With Preserved Ejection Fraction and Malnutrition, run by Beijing Tongren 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 5 inclusion and 10 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 20 Apr 2023. 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?
readmission due to heart failure in the first year after hospitalization (time frame: up to one year). 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?
On the ClinicalTrials.gov record for NCT05586828, which also lists 1 linked publication.
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 20 Apr 2023.