Trials / Completed
CompletedNCT04214899
PLASMA Mexico (PLASMA Mexico)
PLASMA MX (PLASMA Mexico)
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 254 (actual)
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Timeline
- Start date
- 2020-01-30
- Primary completion
- 2023-12-15
- Completion
- 2024-11-25
- First posted
- 2020-01-02
- Last updated
- 2026-01-28
Locations
7 sites across 1 country: Mexico
Source: ClinicalTrials.gov record NCT04214899. Inclusion in this directory is not an endorsement.