Left Ventricular Dysfunction Post Myocardial InfarctionPERGAMENCT01440049
Patient's Management Receiving Eplerenone Therapy
An observational study of Left Ventricular Dysfunction Post Myocardial Infarction, run by Pfizer.
Trial summary
On a population of patients followed by an office-based cardiologist and treated with eplerenone, the objectives of the survey are: To describe the characteristics of the population treated. To describe the methods of use of eplerenone (posology, duration of treatment, medicinal combinations). Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Left Ventricular Dysfunction Post Myocardial Infarction
- What is being tested?
- Prospective Observational
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- Sep 2008to Dec 2010
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The following patients may be selected to participate in the survey: * Those undergoing treatment with eplerenone in accordance with the MA or not, with a known start date. * Those likely to be followed by the same physician for a minimal period of twelve months.
Who may be able to join
- The following patients may be selected to participate in the survey:
- Those undergoing treatment with eplerenone in accordance with the MA or not, with a known start date.
- Those likely to be followed by the same physician for a minimal period of twelve months.
Who cannot join
- Severe Kidney Disease
- Hyperkamiemia more than 5.5
About this study
Official title: Assessment Of Follow-Up Methods For Patients Treated In The Long-Term With A Specific Aldosterone Receptor Antagonist
On a population of patients followed by an office-based cardiologist and treated with eplerenone, the objectives of the survey are:
- To describe the characteristics of the population treated.
- To describe the methods of use of eplerenone (posology, duration of treatment, medicinal combinations).
- To describe the follow-up methods of the treatment.
- To describe the possible interruptions of the treatment
Read the detailed description
A sample size in the region of N = 400 patients will allow this accuracy of estimation, as for this size, the half-width would be equal to 5% for a frequency of 50% corresponding to a confidence interval of maximum width. In view of the type of survey and the need for 12 months of monitoring in the context of standard practice, it may be anticipated that the drop-off rate will be about 20%. A sample size of N = 500 patients was therefore chosen.
- Being tested
- Prospective Observational
- Keywords
- patients with MI- on top of treatment add Eplerenone - assess LVEF and BP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prospective ObservationalOther
this is an observational study non interventional
| Study group | Role | What they receive |
|---|---|---|
| Eplerenone | Not described Receives: Other: Prospective Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic Ejection Fraction as a Measure of Left Ventricular Dysfunction at Inclusion for Full Analysis Set (FAS) Population
Left ventricular dysfunction, a condition in which the left ventricle of the heart exhibits a decreased functionality, was assessed based on systolic ejection fraction. Systolic ejection fraction was the fraction of the end-diastolic volume (EDV) that was ejected out of left ventricle with each contraction.
Measured: Baseline
Systolic Ejection Fraction as a Measure of Left Ventricular Dysfunction at Inclusion for Safety Analysis Set (SAS) Population
Left ventricular dysfunction, a condition in which the left ventricle of the heart exhibits a decreased functionality, was assessed based on systolic ejection fraction. Systolic ejection fraction was the fraction of the end-diastolic volume (EDV) that was ejected out of left ventricle with each contraction.
Measured: Baseline
Percentage of Participants With Eplerenone Treatment Compliance at Month 3 in FAS Population
Participants receiving eplerenone on the basis of the approved summary of product characteristics (SmPC) were said to be treatment compliant.
Measured: Month 3
Percentage of Participants With Eplerenone Treatment Compliance at Month 6 in FAS Population
Participants receiving eplerenone on the basis of the approved SmPC were said to be treatment compliant.
Measured: Month 6
Percentage of Participants With Eplerenone Treatment Compliance at Month 9 in FAS Population
Participants receiving eplerenone on the basis of the approved SmPC were said to be treatment compliant.
Measured: Month 9
Percentage of Participants With Eplerenone Treatment Compliance at Month 12 in FAS Population
Participants receiving eplerenone on the basis of the approved SmPC were said to be treatment compliant.
Measured: Month 12
Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 3 in FAS Population
Change of eplerenone dosage = modified dosage (mg daily) - dosage at start of treatment (mg daily). A positive change indicated dosage increase and a negative change indicated dosage decrease.
Measured: Baseline, Month 3
Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 6 in FAS Population
Change of eplerenone dosage = modified dosage (mg daily) - dosage at start of treatment (mg daily). A positive change indicated dosage increase and a negative change indicated dosage decrease.
Measured: Baseline, Month 6
Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 9 in FAS Population
Change of eplerenone dosage = modified dosage (mg daily) - dosage at start of treatment (mg daily). A positive change indicated dosage increase and a negative change indicated dosage decrease.
Measured: Baseline, Month 9
Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 12 in FAS Population
Change of eplerenone dosage = modified dosage (mg daily) - dosage at start of treatment (mg daily). A positive change indicated dosage increase and a negative change indicated dosage decrease.
Measured: Baseline, Month 12
Percentage of Participants Who Died in SAS Population
Measured: Baseline up to Month 12
Percentage of Participants Hospitalized in FAS Population
Measured: Baseline up to Month 12
Number of Participants With Worsened Renal Function
Measured: Baseline up to Month 12
Secondary outcomes (4)
Number of Participants With Reason for Increased or Decreased Eplerenone Dose
Measured: Baseline up to Month 12
Number of Participants With Concomitant Cardiovascular Treatment in FAS Population
Concomitant cardiovascular treatment included any cardiovascular treatment other than, and in addition to, the study treatment taken at any time during the study.
Measured: Baseline up to Month 12
Number of Participants With Concomitant Cardiovascular Treatment in SAS Population
Concomitant cardiovascular treatment included any cardiovascular treatment other than, and in addition to, the study treatment taken at any time during the study.
Measured: Baseline up to Month 12
Percentage of Participants Who Discontinued Eplerenone Treatment in FAS Population
Measured: Baseline up to Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2011 (estimated)
- Study startSep 2008
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Left Ventricular Dysfunction Post Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by PfizerThe 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
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01440049
- Sponsor's protocol ID
- NRA6140035
- Acronym
- PERGAME
- Status last verified
- Nov 2018
- First submitted
- 14 Sep 2011
- Last updated
- 19 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment Of Follow-Up Methods For Patients Treated In The Long-Term With A Specific Aldosterone Receptor Antagonist
- ClinicalTrials.gov ID
- NCT01440049
- Acronym / sponsor ID
- PERGAME / NRA6140035
- Keywords
- patients with MI- on top of treatment add Eplerenone - assess LVEF and BP
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 26 Sep 2011 (estimated)
- Results
- Posted 30 Jan 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
On a population of patients followed by an office-based cardiologist and treated with eplerenone, the objectives of the survey are:
- To describe the characteristics of the population treated.
- To describe the methods of use of eplerenone (posology, duration of treatment, medicinal combinations).
- To describe the follow-up methods of the treatment.
- To describe the possible interruptions of the treatment
Detailed description
A sample size in the region of N = 400 patients will allow this accuracy of estimation, as for this size, the half-width would be equal to 5% for a frequency of 50% corresponding to a confidence interval of maximum width. In view of the type of survey and the need for 12 months of monitoring in the context of standard practice, it may be anticipated that the drop-off rate will be about 20%. A sample size of N = 500 patients was therefore chosen.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eplerenone | – | Other: Prospective Observational |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The following patients may be selected to participate in the survey: * Those undergoing treatment with eplerenone in accordance with the MA or not, with a known start date. * Those likely to be followed by the same physician for a minimal period of twelve months.
Key inclusion criteria (3 listed)
- Those undergoing treatment with eplerenone in accordance with the MA or not, with a known start date.
- Those likely to be followed by the same physician for a minimal period of twelve months.
Key exclusion criteria (2 listed)
- Severe Kidney Disease
- Hyperkamiemia more than 5.5
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prospective Observationalthis is an observational study non interventional | Other | Eplerenone |
Primary outcome
Systolic Ejection Fraction as a Measure of Left Ventricular Dysfunction at Inclusion for Full Analysis Set (FAS) Population
Time frame: Baseline
Left ventricular dysfunction, a condition in which the left ventricle of the heart exhibits a decreased functionality, was assessed based on systolic ejection fraction. Systolic ejection fraction was the fraction of the end-diastolic volume (EDV) that was ejected out of left ventricle with each contraction.
Systolic Ejection Fraction as a Measure of Left Ventricular Dysfunction at Inclusion for Safety Analysis Set (SAS) Population
Time frame: Baseline
Left ventricular dysfunction, a condition in which the left ventricle of the heart exhibits a decreased functionality, was assessed based on systolic ejection fraction. Systolic ejection fraction was the fraction of the end-diastolic volume (EDV) that was ejected out of left ventricle with each contraction.
Percentage of Participants With Eplerenone Treatment Compliance at Month 3 in FAS Population
Time frame: Month 3
Participants receiving eplerenone on the basis of the approved summary of product characteristics (SmPC) were said to be treatment compliant.
Percentage of Participants With Eplerenone Treatment Compliance at Month 6 in FAS Population
Time frame: Month 6
Participants receiving eplerenone on the basis of the approved SmPC were said to be treatment compliant.
Percentage of Participants With Eplerenone Treatment Compliance at Month 9 in FAS Population
Time frame: Month 9
Participants receiving eplerenone on the basis of the approved SmPC were said to be treatment compliant.
Percentage of Participants With Eplerenone Treatment Compliance at Month 12 in FAS Population
Time frame: Month 12
Participants receiving eplerenone on the basis of the approved SmPC were said to be treatment compliant.
Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 3 in FAS Population
Time frame: Baseline, Month 3
Change of eplerenone dosage = modified dosage (mg daily) - dosage at start of treatment (mg daily). A positive change indicated dosage increase and a negative change indicated dosage decrease.
Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 6 in FAS Population
Time frame: Baseline, Month 6
Change of eplerenone dosage = modified dosage (mg daily) - dosage at start of treatment (mg daily). A positive change indicated dosage increase and a negative change indicated dosage decrease.
Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 9 in FAS Population
Time frame: Baseline, Month 9
Change of eplerenone dosage = modified dosage (mg daily) - dosage at start of treatment (mg daily). A positive change indicated dosage increase and a negative change indicated dosage decrease.
Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 12 in FAS Population
Time frame: Baseline, Month 12
Change of eplerenone dosage = modified dosage (mg daily) - dosage at start of treatment (mg daily). A positive change indicated dosage increase and a negative change indicated dosage decrease.
Percentage of Participants Who Died in SAS Population
Time frame: Baseline up to Month 12
Percentage of Participants Hospitalized in FAS Population
Time frame: Baseline up to Month 12
Number of Participants With Worsened Renal Function
Time frame: Baseline up to Month 12
4 secondary outcomes
Number of Participants With Reason for Increased or Decreased Eplerenone Dose
Time frame: Baseline up to Month 12
Number of Participants With Concomitant Cardiovascular Treatment in FAS Population
Time frame: Baseline up to Month 12
Number of Participants With Concomitant Cardiovascular Treatment in SAS Population
Time frame: Baseline up to Month 12
Percentage of Participants Who Discontinued Eplerenone Treatment in FAS Population
Time frame: Baseline up to Month 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Related trials for Left Ventricular Dysfunction Post Myocardial Infarction
RecruitingPhase 3
DAPAgliflozine to Attenuate Cardiac RemOdeling afTEr aCuTe myOcardial Infarction
AMI, STEMI
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.
Pfizer CT.gov Call Center study director
Pfizer
Questions about this trial
What is this clinical trial studying?
An observational study of Left Ventricular Dysfunction Post Myocardial Infarction, run by Pfizer.
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 2 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 19 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 30 Jan 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Systolic Ejection Fraction as a Measure of Left Ventricular Dysfunction at Inclusion for Full Analysis Set (FAS) Population (time frame: Baseline). The study lists 13 primary outcomes in all. 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 19 Dec 2018.