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| ID | Type | Description | Link |
|---|---|---|---|
| 101112022 | Other Grant/Funding Number | Innovative Health Initiative Joint Undertaking (IHI JU) | |
| No 10088702 | Other Grant/Funding Number | UK Research and Innovation (UKRI) |
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| Name | Class |
|---|---|
| UMCG, University Hospital (Groningen, The Netherlands) | UNKNOWN |
| Leiden University Medical Center | OTHER |
| Erasmus Medical Center | OTHER |
| Uniklinik RTWH Aachen |
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The goal of TAILOR-HF is to integrate clinical data, laboratory parameters, treatment patterns, and circulating biomarkers to identify factors that predict individual response to pharmacological treatment in patients with heart failure.
TAILOR-HF is an observational study with protocol-mandated assessments scheduled at baseline and at 1, 3, and 6 months after enrolment. Additional follow-up data will be collected through telephone visits every 6 months until the last participant has completed the protocol-mandated 6-month visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The cohort | Patients with either de novo HF or (acute) decompensated HF who are not yet on optimal doses of guideline-recommended therapies and in whom up-titration is anticipated. |
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| Measure | Description | Time Frame |
|---|---|---|
| time to death or a worsening heart failure event | time to death or a worsening heart failure event | 6 months, further long time follow up will be conducted by 6 monthly telephone calls until last patient included in the study has completed primary 6 months follow-up. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to cardiovascular (CV) mortality | Time to cardiovascular (CV) mortality | 6 months, further long time follow up will be conducted by 6 monthly telephone calls until last patient included in the study has completed primary 6 months follow-up. |
| Time to first (re)-hospitalization due to heart failure |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with either de novo HF or (acute) decompensated HF who are not yet on optimal doses of guideline-recommended therapies and in whom up-titration is anticipated.
Patients will be enrolled either at the outpatient clinic of participating sites or prior to dis-charge of patients who are hospitalized for worsening HF
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| Charite University, Berlin, Germany | OTHER |
| Ospedale San Donato | OTHER |
| Fidenza Hospital | UNKNOWN |
| Desio Hospital | UNKNOWN |
| Gorizia Hospital | UNKNOWN |
| UZ Antwerpen | UNKNOWN |
| Medizinischen Universität Wien | UNKNOWN |
| University College Dublin | OTHER |
| University of Ulster | OTHER |
| University of Glasgow | OTHER |
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Additional blood samples are collected. These samples will be used for the assessment of biomarkers and proteomic analysis at the end of the trial.
Time to first (re)-hospitalization due to heart failure |
| 6 months, further long time follow up will be conducted by 6 monthly telephone calls until last patient included in the study has completed primary 6 months follow-up. |
| Time to all-cause hospitalization | Time to all-cause hospitalization | 6 months, further long time follow up will be conducted by 6 monthly telephone calls until last patient included in the study has completed primary 6 months follow-up. |
| Change in clinical congestion score(10) between baseline and 6 months | change in score in 7-item Clinical Congestion Index, higher meaning more signs, based on following criteria: Orthopnea, NYHA ≥III, paroxysmal nocturnal dyspnea, hepatomegaly, peripheral pitting edema, jugular venous distension, rales | 6 months |
| Change in QoL according to the KCCQ-CSS between baseline and 6 months | The change in health status from baseline to 6 months will be assessed using the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS). Scores range from 0 to 100, with higher scores indicating better health status, including fewer symptoms and fewer physical limitations. | 6 months |