Chronic Kidney DiseasesNCT06006819
Prognostic Markers of Acute Heart Failure With Chronic Kidney Disease
An observational study of Chronic Kidney Diseases and Acute Heart Failure, run by Cheng-Hsin General Hospital at 1 site in Taiwan.
Trial summary
Acute heart failure (AHF) is defined as new or worsening of symptoms and signs of heart failure and is the most frequent cause of unplanned hospital admission in elderly patients. N-terminal pro-brain natriuretic peptide (NT-pro-BNP) is one of the most developed prognostic markers for AHR patients and. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Chronic Kidney Diseases, Acute Heart Failure, Biomarker
- How many people
- 155 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2023to 23 Dec 2025
- 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 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study participants were recruited from patients admitted to Cheng Hsin General Hospital with the major diagnosis of acute heart failure. After written informed consent was obtained (in compliance with the Helsinki Declaration), patients with age more than 20 were included. Exclusion criteria were initial serum NT-proBNP level <300ng/ml, the presence of amputation, being pregnant, and receiving regular dialysis.
Who may be able to join
- hospitalized for acute heart failure
Who cannot join
- initial serum NT-proBNP level <300ng/ml, pregnancy, amputated, and end-stage renal disease under regular dialysis
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Cheng Hsin General Hospital
Taipei, Baitou District, 112
Shang Feng Yang, MD, +886-22826-4400 ext. 2481, samyang1223@gmail.com
About this study
Official title: Plasma Proteomic Signature and the Prognosis of Acute Heart Failure With or Without Chronic Kidney Disease
Acute heart failure (AHF) is defined as new or worsening of symptoms and signs of heart failure and is the most frequent cause of unplanned hospital admission in elderly patients. N-terminal pro-brain natriuretic peptide (NT-pro-BNP) is one of the most developed prognostic markers for AHR patients and. NT-pro-BNP has limitations in terms of diagnostic or predictive accuracy in patients with chronic kidney disease (CKD). Plasma proteomics have the potential to examine underlying pathophysiological and prognostic roles, so we compared the plasma proteomic signature to predict outcomes of patients with or without CKD hospitalized for AHF.
- Conditions
- Chronic Kidney Diseases, Acute Heart Failure, Biomarker
- Medical subject headings
- Renal Insufficiency, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
major adverse cardiovascular events
mortality, acute myocardial infarction, acute stroke, and heart failure hospitalization
Measured: 1 year
Secondary outcomes (1)
major adverse kidney events
mortality, new end-stage renal disease, and 30% decline in estimated GFR
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 posted23 Aug 2023
- Study start1 Jan 2023
- Primary completion23 Dec 2025 (estimated)
- Study completion23 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies 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
- 155 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cheng-Hsin General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shang Feng Yang, Cheng-Hsin General Hospital
- Investigators
- Shang Feng Yang, MD, Principal investigator, Cheng-Hsin General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06006819
- Sponsor's protocol ID
- CHGH(983)111A-61
- Status last verified
- Aug 2024
- First submitted
- 17 Aug 2023
- Last updated
- 23 Aug 2024
- 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 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasma Proteomic Signature and the Prognosis of Acute Heart Failure With or Without Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT06006819
- Acronym / sponsor ID
- CHGH(983)111A-61
- Conditions
- Chronic Kidney Diseases, Acute Heart Failure, Biomarker
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 155 participants (estimated)
- Lead sponsor
- Cheng-Hsin General HospitalUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 23 Dec 2025 (estimated)
- Study completion
- 23 Dec 2025 (estimated)
- First posted
- 23 Aug 2023 (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.
Acute heart failure (AHF) is defined as new or worsening of symptoms and signs of heart failure and is the most frequent cause of unplanned hospital admission in elderly patients. N-terminal pro-brain natriuretic peptide (NT-pro-BNP) is one of the most developed prognostic markers for AHR patients and. NT-pro-BNP has limitations in terms of diagnostic or predictive accuracy in patients with chronic kidney disease (CKD). Plasma proteomics have the potential to examine underlying pathophysiological and prognostic roles, so we compared the plasma proteomic signature to predict outcomes of patients with or without CKD hospitalized for AHF.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study participants were recruited from patients admitted to Cheng Hsin General Hospital with the major diagnosis of acute heart failure. After written informed consent was obtained (in compliance with the Helsinki Declaration), patients with age more than 20 were included. Exclusion criteria were initial serum NT-proBNP level <300ng/ml, the presence of amputation, being pregnant, and receiving regular dialysis.
Key inclusion criteria (1 listed)
- hospitalized for acute heart failure
Key exclusion criteria (1 listed)
- initial serum NT-proBNP level <300ng/ml, pregnancy, amputated, and end-stage renal disease under regular dialysis
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
major adverse cardiovascular events
Time frame: 1 year
mortality, acute myocardial infarction, acute stroke, and heart failure hospitalization
1 secondary outcome
major adverse kidney events
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
Related trials for Chronic Kidney Diseases
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruiting
An Individuation Intervention to Reduce Socioeconomic Disparities in Chronic Kidney Disease Care
Chronic Kidney Diseases
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.
Shang Feng Yang, MD principal investigator
Cheng-Hsin General 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 Chronic Kidney Diseases and Acute Heart Failure, run by Cheng-Hsin General Hospital at 1 site in Taiwan.
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: status not confirmed, as of the sponsor's last update on 23 Aug 2024. 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 Taiwan. 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 Shang Feng Yang, MD (+886-22826-4400 ext. 2481, samyang1223@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
major adverse cardiovascular events (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 23 Aug 2024.