NCT04757142

Brief Summary

Prospective, multicenter, observational cohort study to collect data on Chilean patients diagnosed with Heart Failure with reduced ejection fraction, their treatments, and their progress in a real-world environment. Additional objectives will be analyzed, such as mortality, and the barriers, if any, to receiving the indicated treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
246

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2021

Typical duration for all trials

Geographic Reach
1 country

6 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

First Submitted

Initial submission to the registry

February 3, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 17, 2021

Completed
22 days until next milestone

Study Start

First participant enrolled

March 11, 2021

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 26, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 12, 2024

Completed
Last Updated

December 31, 2024

Status Verified

February 1, 2024

Enrollment Period

3.1 years

First QC Date

February 3, 2021

Last Update Submit

December 30, 2024

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

  • Identify the main epidemiological and clinical characteristics of patients with Heart Failure with reduced ejection fraction, as well as the medical treatment models used.

    Patient´s baseline characteristics, medical history, socio-economic data, ancillary studies, laboratory tests, and cardiovascular medication will be summarized using summary statistics. Continuous variables will be presented using mean, standard deviation (SD), minimum, median, maximum, and interquartile range (IQR). Categorical variables will be presented as frequency and percentage.

    1 year

Secondary Outcomes (7)

  • Determine the prescription rate of a cardiovascular pharmacological treatment in patients with Heart Failure with reduced ejection fraction

    1 year

  • Determine the prescription rate of a cardiac medical device in patients with Heart Failure with reduced ejection fraction

    1 year

  • Determine the implant rate of a cardiac medical device in patients with Heart Failure with reduced ejection fraction

    1 year

  • Determine the mortality rate and its classification in patients with Heart Failure with reduced ejection fraction during a 12-month period.

    1 year

  • Determine the hospitalization rate for heart failure during the 12-month follow-up.

    1 year

  • +2 more secondary outcomes

Eligibility Criteria

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

Chilean patients diagnosed with Heart Failure with reduced ejection fraction, regardless of the time of disease progression.

You may qualify if:

  • Men and women ≥18 years old.
  • Patients with Heart Failure with Left Ventricular Ejection Fraction (LVEF) ≤ 40% will be included.
  • Patients must be willing to comply with the study requirements and complete the Informed Consent Form (defined as the legally valid and documented confirmation of a patient's voluntary agreement to participate in the clinical study).

You may not qualify if:

  • Patients without Heart Failure or with Heart Failure with Left Ventricular Ejection Fraction (LVEF)\> 40%.
  • Patients unable to comply with the Clinical Investigation Plan.
  • Patients who are already enrolled or plan to participate in a concurrent clinical study of any medication and/or device at any time during the course of this clinical study without prior documented approval of the Medtronic Study Manager.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Hospital Clínico Regional Guillermo Grant Benavente

Concepción, Chile

Location

Hospital Clínico Pontificia Universidad Católica de Chile

Santiago, Chile

Location

Hospital San Juan de Dios

Santiago, Chile

Location

Hospital Talagante

Santiago, Chile

Location

Hospital Hernan Henriquez Aravena

Temuco, Chile

Location

Hospital Dr. Gustavo Fricke

Viña del Mar, Chile

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Claudio Muratore, MD

    Medtronic

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

February 3, 2021

First Posted

February 17, 2021

Study Start

March 11, 2021

Primary Completion

April 26, 2024

Study Completion

November 12, 2024

Last Updated

December 31, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

CL(6)