NCT04214899

Brief Summary

Collect data on Mexican 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, the use of resources associated with the follow-up of this group of patients 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
254

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

Longer than P75 for all trials

Geographic Reach
1 country

7 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

December 3, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 2, 2020

Completed
28 days until next milestone

Study Start

First participant enrolled

January 30, 2020

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2023

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2024

Completed
Last Updated

January 28, 2026

Status Verified

November 1, 2024

Enrollment Period

3.9 years

First QC Date

December 3, 2019

Last Update Submit

January 26, 2026

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

  • Identify the main epidemiological and clinical characteristics of patients with Heart Failure with LVEF ≤ 45%, 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 (5)

  • Determine the prescription rate of a cardiovascular pharmacological treatment and the indication and 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 LVEF ≤ 45%.

    1 year

  • Identify the barriers, if any, to prescribing and implanting a cardiac medical device in those patients with a Class I recommendation according to the ACC/AHA/HRS 2017 guidelines.

    1 year

  • Determine the population with a profile of 1.5 primary prevention of sudden cardiac death

    1 year

  • Collect data on the use of resources associated with the follow-up of patients diagnosed with Heart Failure with reduced ejection fraction during a period of 12 months to perform a secondary economic analysis.

    1 year

Eligibility Criteria

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

Mexican 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
  • Patients with Heart Failure with LVEF ≤ 45% 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 LVEF \> 45%
  • Patients unable of 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 (7)

ICMI: Instituto Cardiovascular de Mínima Invasión

Jalisco, Jalisco, 45116, Mexico

Location

CITIC

Mexico City, Mexico City, 10200, Mexico

Location

CECLIQ: Centro de Estudios Clínicos de Querétaro

Querétaro City, Querétaro, 76000, Mexico

Location

Helimedica

Naucalpan, State of Mexico, 53120, Mexico

Location

Centro Medico ABC Santa Fe

Mexico City, 05348, Mexico

Location

ISSSTE Hospital General Tacuba

Mexico City, 11410, Mexico

Location

Instituto Nacional de Cardiologia

Mexico City, 14080, Mexico

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Claudio Muratore

    Medtronic

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

December 3, 2019

First Posted

January 2, 2020

Study Start

January 30, 2020

Primary Completion

December 15, 2023

Study Completion

November 25, 2024

Last Updated

January 28, 2026

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

ME(7)