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OpenTrials
Completed

NCT Number: NCT04757142

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Clínico Regional Guillermo Grant Benavente, Concepción, Chile

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

    Time frame: 1 year

    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.

Secondary outcomes

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

    Time frame: 1 year

    Percentage of cardiovascular medication prescription by type

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

    Time frame: 1 year

    Percentage of patients with an indication for a cardiac medical device.

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

    Time frame: 1 year

    Percentage of patients implanted with a cardiac medical device.

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

    Time frame: 1 year

    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

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

    Time frame: 1 year

    Percentage of Hospitalizations during the study follow-up period.

  6. 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.

    Time frame: 1 year

    Percentage of reasons for not indicating a cardiac medical device. Number and percentage of reasons for not implanting a cardiac medical device

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

    Time frame: 1 year

    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)

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Rhythm and Heart Failure

Industry

Registry information

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Feb 17, 2021
Registry last updated
Dec 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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