Heart FailureNCT04214899
PLASMA Mexico (PLASMA Mexico)
An observational study of Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 7 sites in Mexico.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- How many people
- 254 participants
- Where
- 7 sitesMexico
- Study dates
- 30 Jan 2020to 25 Nov 2024
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Mexican patients diagnosed with Heart Failure with reduced ejection fraction, regardless of the time of disease progression.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Mexico7 sites
ICMI: Instituto Cardiovascular de Mínima Invasión
Jalisco, Jalisco, 45116
CITIC
Mexico City, Mexico City, 10200
Centro Medico ABC Santa Fe
Mexico City, 05348
ISSSTE Hospital General Tacuba
Mexico City, 11410
Instituto Nacional de Cardiologia
Mexico City, 14080
Helimedica
Naucalpan, State of Mexico, 53120
CECLIQ: Centro de Estudios Clínicos de Querétaro
Querétaro City, Querétaro, 76000
About this study
Official title: PLASMA MX (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.
Read the 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
- Heart Failure
- Medical subject headings
- Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify the main epidemiological and clinical characteristics of patients with Heart Failure with LVEF ≤ 45%, 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.
Measured: 1 year
Secondary outcomes (5)
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
Measured: 1 year
Determine the mortality rate and its classification in patients with Heart Failure with LVEF ≤ 45%.
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
Measured: 1 year
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
Measured: 1 year
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)
Measured: 1 year
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2020
- Study start30 Jan 2020
- Primary completion15 Dec 2023
- Study completion25 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Medtronic Cardiac Rhythm and Heart FailureThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 254 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Claudio Muratore, Study chair, Medtronic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04214899
- Sponsor's protocol ID
- MDT19012
- Status last verified
- Nov 2024
- First submitted
- 3 Dec 2019
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PLASMA MX (PLASMA Mexico)
- ClinicalTrials.gov ID
- NCT04214899
- Acronym / sponsor ID
- MDT19012
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 254 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- 30 Jan 2020 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 25 Nov 2024 (actual)
- First posted
- 2 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Mexican patients diagnosed with Heart Failure with reduced ejection fraction, regardless of the time of disease progression.
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
5 secondary outcomes
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
Determine the mortality rate and its classification in patients with Heart Failure with LVEF ≤ 45%.
Time frame: 1 year
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
Determine the population with a profile of 1.5 primary prevention of sudden cardiac death
Time frame: 1 year
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudio Muratore study chair
Medtronic
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 7 sites in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.