Clinical trial NCT04757142: PLASMA Chile (PLASMA Chile)
Official title: PLASMA Chile (PLASMA Chile)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2021-02-17
Enrollment: 246
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chilean patients diagnosed with Heart Failure with reduced ejection fraction, regardless of the time of disease progression.

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.

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

Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Identify the main epidemiological and clinical characteristics of patients with Heart Failure with reduced ejection fraction, as well as the medical treatment models used.
timeFrame: 1 year
Secondary outcomes:
measure: Determine the prescription rate of a cardiovascular pharmacological treatment in patients with Heart Failure with reduced ejection fraction
timeFrame: 1 year
measure: Determine the prescription rate of a cardiac medical device in patients with Heart Failure with reduced ejection fraction
timeFrame: 1 year
measure: Determine the implant rate of a cardiac medical device in patients with Heart Failure with reduced ejection fraction
timeFrame: 1 year
measure: Determine the mortality rate and its classification in patients with Heart Failure with reduced ejection fraction during a 12-month period.
timeFrame: 1 year
measure: Determine the hospitalization rate for heart failure during the 12-month follow-up.
timeFrame: 1 year
measure: 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.
timeFrame: 1 year
measure: Determine the population with a profile of 1.5 primary prevention of sudden cardiac death
timeFrame: 1 year
Other outcomes:
Locations:
city: Concepción
country: Chile
facility: Hospital Clínico Regional Guillermo Grant Benavente
city: Santiago
country: Chile
facility: Hospital Clínico Pontificia Universidad Católica de Chile
city: Santiago
country: Chile
facility: Hospital San Juan de Dios
city: Santiago
country: Chile
facility: Hospital Talagante
city: Temuco
country: Chile
facility: Hospital Hernan Henriquez Aravena
city: Viña Del Mar
country: Chile
facility: Hospital Dr. Gustavo Fricke
Study officials:
affiliation: Medtronic
name: Claudio Muratore, MD
role: STUDY_DIRECTOR
References: