Clinical trial NCT04214899: PLASMA Mexico (PLASMA Mexico)
Official title: PLASMA MX (PLASMA Mexico)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2020-01-02
Enrollment: 254
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Mexican patients diagnosed with Heart Failure with reduced ejection fraction, regardless of the time of disease progression.

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.

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.
* 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.

Eligibility criteria: 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

Primary outcomes:
measure: Identify the main epidemiological and clinical characteristics of patients with Heart Failure with LVEF ≤ 45%, as well as the medical treatment models used.
timeFrame: 1 year
Secondary outcomes:
measure: 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.
timeFrame: 1 year
measure: Determine the mortality rate and its classification in patients with Heart Failure with LVEF ≤ 45%.
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
measure: 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.
timeFrame: 1 year
Other outcomes:
Locations:
city: Naucalpan
country: Mexico
facility: Helimedica
state: Estado de Mexico
city: Jalisco
country: Mexico
facility: ICMI: Instituto Cardiovascular de Mínima Invasión
city: Mexico City
country: Mexico
facility: Centro Medico ABC Santa Fe
city: Mexico City
country: Mexico
facility: CITIC
city: Mexico City
country: Mexico
facility: ISSSTE Hospital General Tacuba
city: Mexico City
country: Mexico
facility: Instituto Nacional de Cardiologia
city: Querétaro
country: Mexico
facility: CECLIQ: Centro de Estudios Clínicos de Querétaro
Study officials:
affiliation: Medtronic
name: Claudio Muratore
role: STUDY_CHAIR
References: