An observational study in Heart Failure, sponsored by Firalis SA. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-23.
Sponsored by Firalis SA · Observational
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Among 600 studies in Heart Failure with a site in Germany — 107 open to participants now, 137 under way, 19 of them phase 3. Heart Failure · Germany.
Among the 600 studies in Heart Failure with a site in Germany, this one is the 63rd largest by enrollment of the 212 observational ones that give a count, is one of 40 that started in 2014, is one of 212 observational ones, and was the 321st registered.
6,332 studies on the registry are indexed under Heart Failure; 1,392 are open to participants now.
Browse Heart Failure studies →107 of the 600 studies in Heart Failure with a site in Germany are open now. Recruiting first, the newest first:
Leipzig Heart Science gGmbH · Sites in Germany
Ages 18–80
Edwards Lifesciences · Sites in Germany
Ages 18+
Stephan Baldus · Sites in Germany
Ages 18+
Jena University Hospital · Sites in Germany
Ages 18+
AstraZeneca · Sites in Germany, United States, Argentina and 29 more countries
Ages 18+
A study can be open while its sites in Germany have not opened yet or have stopped. Only those recruiting at a site in Germany →
Of the 966 Heart Failure studies recruiting now, 689 (71%) set no upper age limit and 89 (9%) stop at 75 or younger; 63 take children under 18; 96 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
600 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 22 · Phase 2 82 · Phase 3 91 · Phase 4 32
First in 1983; this study’s year is marked. 40 started in 2014.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 620 is above the median of 200 across 1,983 observational studies indexed under Heart Failure.
Median enrollment 161 across the 386 interventional studies, 286 across the 212 observational. Of the 411 that completed or were terminated, 126 (31%) have results posted.
This tab as a report to print or save as PDF → With an account.
356 of 600 have an industry lead sponsor. The 10 most frequent:
Firalis SA is the lead sponsor of 7 studies on the registry; 3 are open to participants now.
Firalis SA has 1 study filed under Heart Failure — fewer than ten, so there is no comparison to draw.
35 of the studies in Heart Failure with a site in Germany that are under way reach primary completion within a year, 5 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06307652Phase 3AstraZenecaStudy to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With Heart Failure and Impaired Kidney Function | 2027-04-16 |
| NCT07038356Phase 3Christian SchulzeEffects of Continued Administration of Empagliflozin in Patients With Heart Failure on Active SGLT2 Inhibitor Treatment Admitted for Acute Decompensated Heart Failure | 2027-04-30 |
| NCT05374291Phase 3University Medical Center GroningenThe RENAL LIFECYCLE Trial: A RCT to Assess the Effect of Dapagliflozin on Renal and Cardiovascular Outcomes in Patients With Severe CKD | 2027-07 |
| NCT06736574Phase 3CytokineticsStudy With Omecamtiv Mecarbil (CK-1827452) to Treat Chronic Heart Failure With Severely Reduced Ejection Fraction | 2027-09 |
| NCT06008197Phase 3Colorado Prevention CenterA Study to Determine the Efficacy and Safety of Finerenone on Morbidity and Mortality Among Hospitalized Heart Failure Patients | 2027-11 |
Add all 35 to your calendar (.ics) → With an account.
Among the 600 studies in Heart Failure with a site in Germany, from their registry updates:
This tab as a report to print or save as PDF → With an account.
CardioSAVE is a prospective 12-month controlled longitudinal study for the validation of a novel predictive model and a diagnostic tool, for the risk stratification of AMI patients undergoing PCI, with a one year follow-up.
Study rational:
Acute Myocardial Infarction (AMI), a common manifestation of coronary artery disease (CAD), is associated with a relatively high incidence and fatality rate. Myocardial Infarction (MI), commonly known as "heart attack", which usually results from an impaired blood supply often caused by thrombus formation in a coronary vessel, resulting in an acute reduction of oxygen supply to a portion of the myocardium. Reperfusion using primary angioplasty through percutaneous coronary intervention (PCI) was proven to be superior to other methods in reducing the fatality rate of the acute phase of the AMI.
During the last decade tremendous efforts have been given to the identification of cardiac biomarkers (BMs) for the diagnosis of AMI. Cardiac BMs have been proven extremely useful in facilitating the diagnostic as well as the timing of therapeutic intervention and in addressing important questions in terms of physiopathology . This resulted in the extensive use of BMs such as troponins in the diagnosis of MI.
Firalis and the Luxembourg general hospital have identified novel biomarkers that could serve as independent risk predictors and prognostic markers for cardiac and clinical complications. First to confirm the value of our identified biomarker panels and to increase their diagnostic/predictive performance, Firalis will identify novel BMs in patient undergoing PCI to include novel biomarkers in this panel and develop a novel early stage prognostic test for clinical outcome in acute myocardial infarction (AMI) patients receiving percutaneous coronary intervention (PCI). This novel test will also be able to monitor treatment response.
For this purpose, the predictive and diagnostic value of the candidate biomarker set have to be clinically validated in a controlled prospective study conducted by the Bad Krozingen Hearth Center. The sample and data collected in this proof of concept study will constitute an independent validation set at the Bad Krozingen Heart Center. Early time point samples will be used to estimate the risk associated with patients and the data obtained will be correlated with the one year outcome of patients.
The development and successful implementation of such diagnostic assay will have strong impact on the quality of care AMI patients, and will significantly reduce costs for healthcare and economy.
Primary objectives:
Secondary objectives:
Study design:
CardioSAVE is a prospective 12-month controlled longitudinal study in 600 AMI patients, with a one year follow-up conducted by the Bad Krozingen Heart Center. The objectif is to validate a novel predictive model and a diagnostic tool, for the risk stratification of AMI patients undergoing PCI. The sample and data collected by eCRF will allow to set up a prototype personalized medicine device focusing on Heart Failure (HF) induced by AMI. The primary endpoint will be the proportion of patients with left ventricular ejection fraction (LVEF) \< 40% at 6 months. The main secondary endpoint is recovery of regional wall motion measured by cMRI at 6 months. Early time point samples, cMRI at day 3 and other clinical patient data will be used to estimate the risk associated with patients and the data obtained will be correlated with the one year outcome of patients.
Acute Myocardial Infarction (AMI) patients undergoing Percutaneous Coronary Intervention (PCI)
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Acute myocardial infarction with clinical decision to treat with percutaneous coronary intervention
Primary PCI for myocardial infarction:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Left Ventricular Ejection Fraction (LVEF) < 40%
Proportion of patients with LV-EF \< 40% at 6 months or Death and/or occurence of serious cardiovascular events such as reinfarction, onset of a cardiovascular disease (e.g. heart failure).
Time frame: At 6 months after PCI
Recovery of regional wall motion
Recovery of regional wall motion measured by cMRI at 6 months
Time frame: At 6 months after PCI
Plan to share: No
No publications or documents are linked to this record.
Ran from Sep 2014 to primary completion in Nov 2020, 74 months.
Of 182 industry-sponsored observational studies under Heart Failure, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 57. This study's 74 months is above that.
Counting every sponsor, half of 976 studies reached it within 41 months; a quarter within 23 and three quarters within 89.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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Firalis SA