NCT06006819

Brief 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. 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
155

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 17, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 23, 2023

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 23, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 23, 2025

Completed
Last Updated

August 23, 2024

Status Verified

August 1, 2024

Enrollment Period

3 years

First QC Date

August 17, 2023

Last Update Submit

August 21, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • major adverse cardiovascular events

    mortality, acute myocardial infarction, acute stroke, and heart failure hospitalization

    1 year

Secondary Outcomes (1)

  • major adverse kidney events

    1 year

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • hospitalized for acute heart failure

You may not qualify if:

  • initial serum NT-proBNP level \<300ng/ml, pregnancy, amputated, and end-stage renal disease under regular dialysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cheng Hsin General Hospital

Taipei, Baitou District, 112, Taiwan

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Shang Feng Yang, MD

    Cheng-Hsin General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shang Feng Yang, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physician

Study Record Dates

First Submitted

August 17, 2023

First Posted

August 23, 2023

Study Start

January 1, 2023

Primary Completion

December 23, 2025

Study Completion

December 23, 2025

Last Updated

August 23, 2024

Record last verified: 2024-08

Locations