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| Name | Class |
|---|---|
| Ikazia Hospital, Rotterdam | OTHER |
| Franciscus Gasthuis & Vlietland (Hospital) | OTHER |
| OLVG | NETWORK |
| Universitair Ziekenhuis Brussel |
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The primary objective is to investigate the association between temporal evolutions of blood biomarkers and clinical adverse events, in order to produce a dynamic, individual, and accurate prediction model for patients with HFpEF.
Moreover several secondary objectives will be investigated.
This is a prospective, observational multi-center cohort study which will be conducted at the cardiology departments of the Erasmus Medical Centre (EMC) as well as five other hospitals. A total of 200 HFpEF patients will be included in the study via the outpatient clinics. The follow-up period will constitute a minimum of 2 years and a maximum of 3.5 years. Clinical data will be collected at baseline and blood samples will be collected at baseline and subsequently every 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Heart failure patients visiting the outpatient clinic | Heart failure patients visiting the outpatient clinic |
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| Measure | Description | Time Frame |
|---|---|---|
| The primary endpoint is the number of participants with a combined endpoint of: urgent visit resulting in intravenous therapy for HF, hospital readmission for acute or worsened HF, and cardiovascular death. | This is a composite endpoint; therefore, the first occurrence of any of the described components will result in the endpoint being met for an individual patient. | Every 6 months, up to 3,5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with urgent visit resulting in intravenous therapy for heart failure | Every 6 months, up to 3,5 years | |
| Number of patients with hospital readmission for acute or worsened HF | Every 6 months, up to 3.5 years |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with a (suspected) diagnosis of HFpEF will be recruited through the Cardiology outpatient clinics of the Erasmus MC and five other hospitals.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Isabella Kardys, Prof. | Contact | +31650032051 | i.kardys@erasmusmc.nl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Noordwest Ziekenhuisgroep | Recruiting | Alkmaar | North Holland | 1815JD | Netherlands |
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| OTHER |
| Noordwest Ziekenhuisgroep | OTHER |
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Blood (EDTA plasma, citrate plasma, serum) and urine samples are taken at the day of inclusion and at follow-up visits, which will be performed every 6 months, until the end of the scheduled follow-up, or until the patient dies. The maximum total number of samples per patient is 8 (in patients with 3.5 year follow-up).
| Number of participants with cardiovascular death. | Every 6 months, up to 3.5 years |
| Number of participants with the combined endpoint urgent visit resulting in intravenous therapy for HF, hospital readmission for acute or worsened HF, and all-cause death. | This is a composite endpoint; therefore, the first occurrence of any of the described components will result in the endpoint being met for an individual patient. | Every 6 months, up to 3,5 years |
| Number of partcipants with all-cause death | Every 6 months, up to 3,5 years |
| Number of participants with the combined endpoint of myocardial infarction (fatal and non-fatal), stroke (fatal and non-fatal), percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) | This is a composite endpoint; therefore, the first occurrence of any of the described components will result in the endpoint being met for an individual patient. | Every 6 months, up to 3,5 years |
| Number of participants with cardiovascular disease (includes all of the above-mentioned components, except all-cause death) | This is a composite endpoint; therefore, the first occurrence of any of the described components will result in the endpoint being met for an individual patient. | Every 6 months, up to 3,5 years |
| Amsterdam UMC | Recruiting | Amsterdam | North Holland | 1081HV | Netherlands |
|
| OLVG Ziekenhuis | Recruiting | Amsterdam | North Holland | 1091AC | Netherlands |
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| Franciscus Gasthuis & Vlietland Ziekenhuis | Recruiting | Rotterdam | South Holland | 3004BA | Netherlands |
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| Erasmus MC | Recruiting | Rotterdam | South Holland | 3015GD | Netherlands |
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| Ikazia Ziekenhuis | Recruiting | Rotterdam | South Holland | 3083AN | Netherlands |
|
| ID | Term |
|---|---|
| D054144 | Heart Failure, Diastolic |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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