NCT06515366

Brief Summary

Aim of this observational study is to evaluate the relationship between mean arterial pressure (MAP) and mortality in patients presenting to the emergency department with acute heart failure, focusing on emergency department monitoring and subgroup presentations. Our goal is to determine the impact of subgroup characteristics on mortality among patients presenting with heart failure in the emergency department, and to assess the predictive value and significance of MAP in predicting mortality.

Trial Health

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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
280

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2024

Shorter than P25 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 17, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 23, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

July 23, 2024

Status Verified

July 1, 2024

Enrollment Period

1 year

First QC Date

July 17, 2024

Last Update Submit

July 17, 2024

Conditions

Keywords

heart failuremean arterial pressureemergency department

Outcome Measures

Primary Outcomes (1)

  • mortality

    patients having mortaility within 1 month of follow up

    1 month

Secondary Outcomes (1)

  • re-hospitalization

    1 month

Study Arms (4)

MAP ≤ 65 mmHg

patient having heart failure symptoms with known heart failure and presenting to emergency department with a mean arterial pressure ≤ 65 mmHg

MAP 66-80 mmHg

patient having heart failure symptoms with known heart failure and presenting to emergency department with a mean arterial pressure between 66-80 mmHg

MAP 81-100 mmHg

patient having heart failure symptoms with known heart failure and presenting to emergency department with a mean arterial pressure between 81-100 mmHg

MAP >100 mmHg

patient having heart failure symptoms with known heart failure and presenting to emergency department with a mean arterial pressure between \>100 mmHg

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients over the age of 18 with known heart failure, presenting to emergency department with acute exacerbation of heart failure symptoms will be grouped according to their measured mean arterial pressure (MAP)

You may qualify if:

  • Age 18 and above Patients presenting with symptoms of heart failure

You may not qualify if:

  • Age under 18 Patients presenting with ST-elevation myocardial infarction Patients with acute kidney failure Pregnant patients Patients with inaccessible data for the parameters under study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Etlik City Hospital

Ankara, Yenimahalle, 06170, Turkey (Türkiye)

RECRUITING

Related Publications (3)

  • Ma H, Li H, Sheng S, Quan L, Yang Z, Xu F, Zeng W. Mean arterial pressure and mortality in patients with heart failure: a retrospective analysis of Zigong heart failure database. Blood Press Monit. 2023 Dec 1;28(6):343-350. doi: 10.1097/MBP.0000000000000674. Epub 2023 Sep 14.

    PMID: 37702595BACKGROUND
  • Burstein B, Tabi M, Barsness GW, Bell MR, Kashani K, Jentzer JC. Association between mean arterial pressure during the first 24 hours and hospital mortality in patients with cardiogenic shock. Crit Care. 2020 Aug 20;24(1):513. doi: 10.1186/s13054-020-03217-6.

    PMID: 32819421BACKGROUND
  • Gao Q, Lin Y, Xu R, Zhang Y, Luo F, Chen R, Li P, Nie S, Li Y, Su L. Association between mean arterial pressure and clinical outcomes among patients with heart failure. ESC Heart Fail. 2023 Aug;10(4):2362-2374. doi: 10.1002/ehf2.14401. Epub 2023 May 12.

    PMID: 37177860BACKGROUND

MeSH Terms

Conditions

Heart FailureEmergencies

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • gulsen akcay, ass. prof.

    ass. prof. of organization

    STUDY DIRECTOR

Central Study Contacts

gulsen akcay, ass. prof.

CONTACT

elif hamzacebioglu kayisoglu, specialist

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2024

First Posted

July 23, 2024

Study Start

June 1, 2024

Primary Completion

June 1, 2025

Study Completion

June 1, 2025

Last Updated

July 23, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations