PLASMA Chile (PLASMA Chile)

Heart Failure Clinical Trial

Official title:

PLASMA Chile (PLASMA Chile)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04757142
• Other study ID #: MDT20035
• Status: Active, not recruiting
• Start date: March 11, 2021
• Est. completion date: June 2024

Study information

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

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 246
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure

Locations

Country	Name	City	State
Chile	Hospital Clínico Regional Guillermo Grant Benavente	Concepción
Chile	Hospital Clínico Pontificia Universidad Católica de Chile	Santiago
Chile	Hospital San Juan de Dios	Santiago
Chile	Hospital Talagante	Santiago
Chile	Hospital Hernan Henriquez Aravena	Temuco
Chile	Hospital Dr. Gustavo Fricke	Viña Del Mar

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm and Heart Failure

Country where clinical trial is conducted

Chile, 

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 in patients with Heart Failure with reduced ejection fraction	Percentage of cardiovascular medication prescription by type	1 year
Secondary	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
Secondary	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
Secondary	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
Secondary	Determine the hospitalization rate for heart failure during the 12-month follow-up.	Percentage of Hospitalizations during the study follow-up period.	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.	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	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