NCT05180370

Brief Summary

ADAPTATION HF is a prospective, observational, cross-sectional, multicenter, survey-based study. Patients who applied to the cardiology outpatient clinic with a preliminary diagnosis of HF or were hospitalized for HF and had a diagnosis of HF for at least 6 months 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
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2021

Shorter than P25 for all trials

Geographic Reach
1 country

10 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 15, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 3, 2021

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 6, 2022

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2022

Completed
Last Updated

February 23, 2023

Status Verified

February 1, 2023

Enrollment Period

11 months

First QC Date

September 3, 2021

Last Update Submit

February 22, 2023

Conditions

Heart Failure

Keywords

Heart FailureQuestionnaireECHOProspectiveCross-Sectional

Outcome Measures

Primary Outcomes (1)

  • General Status of the patients

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

    6 months

Secondary Outcomes (6)

  • HF Risk Factors

    6 Months

  • HF Percutaneous Intervention History & Operation History

    6 Months

  • Medications Used for HF

    6 Months

  • HF Comorbidities

    6 Months

  • HF ECHO Results

    6 Months

  • +1 more secondary outcomes

Study Arms (1)

Outpatient or inpatient diagnosed with Heart Failure at least 6 months ago

ADAPTATION HF is a prospective, observational, cross-sectional, multicenter, survey-based study. Patients who applied to the cardiology outpatient clinic with a preliminary diagnosis of HF or were hospitalized for HF and had a diagnosis of HF for at least 6 months will be included in the study.

Other: Questionnaies

Interventions

QuestionnaiesOTHER

Data entry staff who will be assigned to the centers for 2 weeks will apply a questionnaire consisting of different questions to the patients referred to them by clinicians with the diagnosis of HF (presented in the appendix to this protocol). In addition, Pittsburg Sleep Quality Index will be applied to all cases.

Outpatient or inpatient diagnosed with Heart Failure at least 6 months ago

Eligibility Criteria

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

Cases admitted to the cardiology outpatient clinic or hospitalized for Heart Failure and diagnosed with HF for at least 6 months will be included in the study.

You may qualify if:

  • Outpatient or inpatient diagnosed with Heart Failure at least 6 months ago
  • Male or female patient aged 18 and over
  • Signed written informed consent form

You may not qualify if:

  • newly diagnosed heart failure
  • CRY requiring dialysis
  • Serious liver and lung disease
  • LVAD/heart transplantation
  • HF due to possible temporary cause (myocarditis, peripartum CMP in the first 6 months, takotsubo etc.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Ankara City Hospital

Ankara, Turkey (Türkiye)

Location

Akdeniz University Medical Faculty

Antalya, Turkey (Türkiye)

Location

Eskişehir Osmangazi University Medical Faculty

Eskişehir, Turkey (Türkiye)

Location

Başkent University Istanbul Health Practice and Research Center Hospital

Istanbul, Turkey (Türkiye)

Location

Dr. Siyami Ersek Chest Cardiac and Vascular Surgery T&R Hospital

Istanbul, Turkey (Türkiye)

Location

Istanbul University - Cerrahpaşa, Cardiology Institute

Istanbul, Turkey (Türkiye)

Location

Dokuz Eylül University Medical Faculty

Izmir, Turkey (Türkiye)

Location

Ege University Medical Faculty

Izmir, Turkey (Türkiye)

Location

Tepecik Training and Research Hospital

Izmir, Turkey (Türkiye)

Location

Mersin University Medical Faculty

Mersin, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

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 15, 2021

Primary Completion

January 31, 2022

Study Completion

January 31, 2022

Last Updated

February 23, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

TU(10)