Heart FailureNCT04757142
PLASMA Chile (PLASMA Chile)
An observational study of Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 6 sites in Chile.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- How many people
- 246 participants
- Where
- 6 sitesChile
- Study dates
- 11 Mar 2021to 12 Nov 2024
- 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: Chilean 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 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).
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Chile6 sites
Hospital Clínico Regional Guillermo Grant Benavente
Concepción
Hospital Clínico Pontificia Universidad Católica de Chile
Santiago
Hospital San Juan de Dios
Santiago
Hospital Talagante
Santiago
Hospital Hernan Henriquez Aravena
Temuco
Hospital Dr. Gustavo Fricke
Viña del Mar
About this study
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.
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.
- 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 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.
Measured: 1 year
Secondary outcomes (7)
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
Measured: 1 year
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.
Measured: 1 year
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.
Measured: 1 year
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
Measured: 1 year
Determine the hospitalization rate for heart failure during the 12-month follow-up.
Percentage of Hospitalizations during the study follow-up period.
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.
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
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2021
- Study start11 Mar 2021
- Primary completion26 Apr 2024
- Study completion12 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
- 246 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Claudio Muratore, MD, Study director, Medtronic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04757142
- Sponsor's protocol ID
- MDT20035
- Status last verified
- Feb 2024
- First submitted
- 3 Feb 2021
- Last updated
- 31 Dec 2024
- 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 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PLASMA Chile (PLASMA Chile)
- ClinicalTrials.gov ID
- NCT04757142
- Acronym / sponsor ID
- MDT20035
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 246 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- 11 Mar 2021 (actual)
- Primary completion
- 26 Apr 2024 (actual)
- Study completion
- 12 Nov 2024 (actual)
- First posted
- 17 Feb 2021 (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.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chilean 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 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).
Key exclusion criteria (3 listed)
- 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.
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 reduced ejection fraction, 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.
7 secondary outcomes
Determine the prescription rate of a cardiovascular pharmacological treatment in patients with Heart Failure with reduced ejection fraction
Time frame: 1 year
Determine the prescription rate of a cardiac medical device in patients with Heart Failure with reduced ejection fraction
Time frame: 1 year
Determine the 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 reduced ejection fraction during a 12-month period.
Time frame: 1 year
Determine the hospitalization rate for heart failure during the 12-month follow-up.
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
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 31 Dec 2024.
- 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, MD study director
Medtronic
6 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 6 sites in Chile.
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 31 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Chile. 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 reduced ejection fraction, 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 31 Dec 2024.