NCT05180396

Brief Summary

The AWARENESS HF-PD is a cross-sectional, multicenter, survey-based study. Cases who were admitted to the outpatient clinic and hospitalized with the diagnosis of Heart Failure (Acute and Chronic) will be included in the study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2021

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

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

March 12, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 3, 2021

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2021

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 6, 2022

Completed
Last Updated

February 23, 2023

Status Verified

February 1, 2023

Enrollment Period

5 months

First QC Date

September 3, 2021

Last Update Submit

February 22, 2023

Conditions

Keywords

Heart FailureQuestionnaireECHOProspective

Outcome Measures

Primary Outcomes (2)

  • Demographics

    At the end of the six-month recruitment period, demographic, symptoms, clinical follow-up status, d will be performed on all included patients.

    6 months

  • Disease Information

    At the end of the six-month recruitment period disease information, treatment compliance, and awareness assessment will be performed on all included patients.

    6 months

Secondary Outcomes (5)

  • HF Risk Factors (BMI, Diabetes, Hypertension, HLP, Tobbaco Use, CV Hereditary, Menapause, MI History and History of CMP in family)

    6 months

  • HF Percutaneous Intervention / Operation History (CRT, ICD, CRT-DI, Pacemaker, PKG, CABG and Heart Valve Operations)

    6 months

  • HF Comorbidities (CAD, AF, COPD, CRF, Anemia, Iron Defficiency, Hypo- Hypertiroidy, OSAS)

    6 months

  • HF Laboratory Results (Glucose, BUN, Creatinine, GFR, Sodium, Potassium, Nt-ProBNP, ALT, AST, ALP, HS-CRP, cTN, Hemoglobine, WBC, Ferritine, TSAD, LDL, tryglyceride, ST3, GGT, INR, ST4)

    6 months

  • HF ECHO Results (EF, LA, SID, Mitral Defficiency, SPAB, DID, Septum, SEG Muscle Weakness, Trial Defficiency)

    6 Months

Study Arms (1)

Cases with the diagnosis of Heart Failure (Acute and Chronic)

Application of a questionnaire consisting of different questions to patients.

Other: Questionnaires

Interventions

Application of a study based questionnaire described in the protocol

Cases with the diagnosis of Heart Failure (Acute and Chronic)

Eligibility Criteria

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

Cases with the diagnosis of Heart Failure (Acute and Chronic) who were admitted to the outpatient clinic and hospitalized will be included in the study. It is planned to include 200 patients from 3 centers in this study.

You may qualify if:

  • Male or female patients aged 18 and over
  • Patients diagnosed with acute or chronic heart failure
  • Patients who agreed to participate in the study

You may not qualify if:

  • Patients who stated that they did not agree to participate in the study
  • Patients who were not diagnosed with Heart Failure or whose diagnosis was changed or not confirmed during the index application
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Akdeniz University Medical Faculty

Antalya, Turkey (Türkiye)

Location

Kahramanmaraş Sütçü İmam University Medical Faculty

Kahramanmaraş, Turkey (Türkiye)

Location

Mersin University Medical Faculty

Mersin, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2021

First Posted

January 6, 2022

Study Start

March 12, 2021

Primary Completion

July 30, 2021

Study Completion

September 10, 2021

Last Updated

February 23, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations