MAP( Mean Arterial Pressure) and Mortality Relation in Patients With Heart Failure

July 17, 2024 updated by: Saglik Bilimleri Universitesi

Evaluation of the Relationship Between Mean Arterial Pressure (MAP) and Mortality in Patients With Heart Failure: A Perspective From Emergency Department Monitoring and Hospital Presentation

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

After obtaining ethical approval, the study will commence within 2 weeks and continue for 1 year. Based on clinical statistics or general literature data, and considering sample size calculations, a total of 280 patients across 4 groups have been determined.

Inclusion Criteria:

Age 18 and above Patients presenting with symptoms of heart failure

Exclusion Criteria:

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

Groups based on initial mean arterial pressure (MAP) upon hospital admission will be established as follows: <65 mmHg, 66-80 mmHg, 81-100 mmHg, >100 mmHg. Data including results of emergency department tests and pertinent findings will be recorded for patients in these groups. The 30-day mortality rates of these patients will be statistically evaluated based on their MAP values and the procedures performed during emergency department monitoring.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
280

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Turkey
    • Yenimahalle
      • Ankara, Yenimahalle, Turkey, 06170
        • Recruiting
        • Etlik city hospital
        • Contact:
        • Principal Investigator:
          • gulsen akcay, ass. prof
        • Sub-Investigator:
          • bedriye muge sonmez, ass.prof.
        • Contact:
        • Sub-Investigator:
          • elif hamzacebioglu kayisoglu, specialist
        • Sub-Investigator:
          • faruk meric, resident
        • Sub-Investigator:
          • Murat OZDEMIR, specialist

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability 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)

Description

Inclusion Criteria:

Age 18 and above Patients presenting with symptoms of heart failure

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
mortality
Time Frame: 1 month
patients having mortaility within 1 month of follow up
1 month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
re-hospitalization
Time Frame: 1 month
patients being re-hospitalized within 1 month after discharge from hospital
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Saglik Bilimleri Universitesi

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ankara Etlik City Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: gulsen akcay, ass. prof., ass. prof. of organization

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 17, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 17, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 23, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 23, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 17, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MAP and Mortality

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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