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OpenTrials
Completed

NCT Number: NCT04214899

PLASMA Mexico (PLASMA Mexico)

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.

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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

ICMI: Instituto Cardiovascular de Mínima Invasión, Jalisco, Mexico

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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.
  • Determine the prescription rate of a cardiovascular pharmacological treatment and the prescription and implant rate of a cardiac medical device in patients with Heart Failure with reduced ejection fraction.
  • Determine the mortality rate and its classification in patients with Heart Failure with reduced ejection fraction.
  • 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.
  • Determine the population with a profile of 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).
  • 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.

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
  • 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)

Exclusion criteria

  • 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

Treatment and study plan

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.

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

    Time frame: 1 year

    Number and percentage of cardiovascular medication prescription by type Number and percentage of patients with an indication for a cardiac medical device Number and percentage of patients referred for an implant of a cardiac medical device Number and percentage of patients who received an implant of a cardiac medical device

  2. Determine the mortality rate and its classification in patients with Heart Failure with LVEF ≤ 45%.

    Time frame: 1 year

    Number and 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

  3. 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

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

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

    Time frame: 1 year

    Number and 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)

  5. 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.

    Time frame: 1 year

    Analysis will include Continuous variables will be summarized using mean, SD, minimum, median, maximum, and IQR.

    Categorical variables will be summarized as number and percentage of total patients.

    Analysis of health resources of the population at 6 and 12 months will be made using Student's t test if they have a normal distribution, or a Mann-Whitney U test in case of a non-normal distribution.

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Rhythm and Heart Failure

Industry

Registry information

Official study title

PLASMA MX (PLASMA Mexico)

Important dates

Study start
2020
Primary completion
2023
Study completion
2024
First posted
Jan 2, 2020
Registry last updated
Jan 28, 2026

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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