PLASMA Mexico (PLASMA Mexico)

Heart Failure Clinical Trial

Official title:

PLASMA MX (PLASMA Mexico)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04214899
• Other study ID #: MDT19012
• Status: Active, not recruiting
• Start date: January 30, 2020
• Est. completion date: May 1, 2024

Study information

• Verified date: February 2024
• Source: Medtronic Cardiac Rhythm and Heart Failure
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 254
• Est. completion date: May 1, 2024
• Est. primary completion date: December 15, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Locations

Country	Name	City	State
Mexico	ICMI: Instituto Cardiovascular de Mínima Invasión	Jalisco
Mexico	Centro Medico ABC Santa Fe	Mexico City
Mexico	CITIC	Mexico City
Mexico	Instituto Nacional de Cardiologia	Mexico City
Mexico	ISSSTE Hospital General Tacuba	Mexico City
Mexico	Helimedica	Naucalpan	Estado De Mexico
Mexico	CECLIQ: Centro de Estudios Clínicos de Querétaro	Querétaro

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm and Heart Failure

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	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	1 year
Secondary	Determine the mortality rate and its classification in patients with Heart Failure with reduced ejection fraction.	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	1 year
Secondary	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.	Number and percentage of reasons for not indicating a cardiac medical device Number and percentage of reasons for not implanting a cardiac medical device	1 year
Secondary	Determine the population with a profile of 1.5 primary prevention of sudden cardiac death	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)	1 year
Secondary	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.	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.	1 year