PLASMA Chile (PLASMA Chile)

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure

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.

• Study Type: Observational
• Enrollment (Actual): 246

Contacts and Locations

Study Locations

• Chile
  • Concepción, Chile
    • Hospital Clínico Regional Guillermo Grant Benavente
  • Santiago, Chile
    • Hospital San Juan de Dios
  • Santiago, Chile
    • Hospital Clínico Pontificia Universidad Católica de Chile
  • Santiago, Chile
    • Hospital Talagante
  • Temuco, Chile
    • Hospital Hernán Henríquez Aravena
  • Viña Del Mar, Chile
    • Hospital Dr. Gustavo Fricke

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine the prescription rate of a cardiovascular pharmacological treatment in patients with Heart Failure with reduced ejection fraction	Percentage of cardiovascular medication prescription by type	1 year
Determine the prescription rate of a cardiac medical device in patients with Heart Failure with reduced ejection fraction	Percentage of patients with an indication for a cardiac medical device.	1 year
Determine the implant rate of a cardiac medical device in patients with Heart Failure with reduced ejection fraction	Percentage of patients implanted with a cardiac medical device.	1 year
Determine the mortality rate and its classification in patients with Heart Failure with reduced ejection fraction during a 12-month period.	Percentage of deaths during the study follow-up period Number and percentage of deaths according to their classification. Risk assessment of sudden cardiac death in the population. Risks comparison of sudden death at 6 and 12 months of follow-up	1 year
Determine the hospitalization rate for heart failure during the 12-month follow-up.	Percentage of Hospitalizations during the study follow-up period.	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.	Percentage of reasons for not indicating a cardiac medical device. Number and percentage of reasons for not implanting a cardiac medical device	1 year
Determine the population with a profile of 1.5 primary prevention of sudden cardiac death	Frequency of patients with indication for 1.5 primary prevention of sudden cardiac death (patients with Heart Failure in primary prevention who have one or more of the following risk factors: syncope or pre-syncope; left ventricular ejection fraction less than 25%; presence of non-sustained ventricular tachycardia; more than 10 ventricular extrasystoles per hour observed in a 24-hour Holter)	1 year

Collaborators and Investigators

• Sponsor: Medtronic Cardiac Rhythm and Heart Failure
• Investigators: Study Director: Claudio Muratore, MD, Medtronic

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2021
• Primary Completion (Actual): April 26, 2024
• Study Completion (Actual): November 12, 2024

Study Registration Dates

• First Submitted: February 3, 2021
• First Submitted That Met QC Criteria: February 14, 2021
• First Posted (Actual): February 17, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 30, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: MDT20035

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No