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| Name | Class |
|---|---|
| Brahms AG | INDUSTRY |
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In this pilot, investigator-initiated multi-centre, multinational, observational study the investigators would like to examine the impact of therapy optimization on the level of biomarkers in patients with acute decompensated and decompensated chronic heart failure.
The primary objective is to determine the best time point for measuring biomarker levels during therapy optimization in patients with decompensation to predict clinical outcomes such as mortality, hospitalisation, and quality of life.
Secondary objectives are:
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| Measure | Description | Time Frame |
|---|---|---|
| Time to first event - all cause death - cardiovascular death - all cause hospitalisation - cardiovascular hospitalisation - hospitalization for heart failure | Time to first event
| from study start (day 1) during hosptialisation until second year of follow up |
| Measure | Description | Time Frame |
|---|---|---|
| quality of life | The EuroQoL EQ-5D quality of life scale consists of 5 items scaled 1 to 3 reflecting different dimensions of quality of life and a visual analog scale measuring overall self-rated health. The Short Form 36 Health Survey. The Hospital Anxiety and Depression Scale (HADS) consists of 14 items measuring symptoms of anxiety and depression in physically ill patients. The ENRICHD Social Support Instrument (ESSI) has been developed as a brief tool for measuring perceived social support in the large randomized ENRICHD study. |
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Inclusion Criteria:
Male or female patients ≥ 18 years.
Hospitalized for ADHF or decompensated chronic heart failure. Patients who develop ADHF while hospitalized for another reason are not eligible.
The underlying primary etiology for decompensation should be cardiac rather than pulmonary disease. For this study, all of the following must be observable at the time of screening:
Able to begin study within 24 hours from presentation to the hospital, including time spent in the emergency department.
Be adequately informed of the nature and risks of the study and give written informed consent prior to study start.
Exclusion Criteria:
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patients with acute decompensated and decompensated chronic heart failure
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité Campus Virchow Klinikum-Medizinische Klinik mit Schwerpunkt Kardiologie | Berlin | 13353 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37891464 | Derived | Veskovic J, Cvetkovic M, Tahirovic E, Zdravkovic M, Apostolovic S, Kosevic D, Loncar G, Obradovic D, Matic D, Ignjatovic A, Cvetkovic T, Posch MG, Radenovic S, Ristic AD, Dokic D, Milosevic N, Panic N, Dungen HD. Depression, anxiety, and quality of life as predictors of rehospitalization in patients with chronic heart failure. BMC Cardiovasc Disord. 2023 Oct 27;23(1):525. doi: 10.1186/s12872-023-03500-8. | |
| 31659915 |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D003919 | Diabetes Insipidus |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| from study start (day 1) during hosptialisation until second year of follow up |
| Six-minute walk test distance | Six-minute walk test distance will be performed at Visit 1-6 a s well as Follow-up after first and second year. | from study start (day 1) during hosptialisation until second year of follow up |
| Echocardiographic parameters | Echocardiography (done within the first seven days from the day of entering the study): dimensions of the left ventricle, wall thickness and EF per Simpson (if it is not possible to determine EF per Simpson in particular cases due to very limited sound conditions, then it could be visually assessed by an experienced echocardiographer), diastolic function of the left ventricle per the American Society of Echocardiography (ASE): mitral Doppler, tissue Doppler, pulmonary vein Doppler. | from study start (day 1) during hosptialisation until second year of follow up |
| Derived |
| Zelenak C, Chavanon ML, Tahirovic E, Trippel TD, Tscholl V, Stroux A, Veskovic J, Apostolovic S, Obradovic D, Zdravkovic M, Loncar G, Stork S, Herrmann-Lingen C, Dungen HD. Early NT-proBNP and MR-proANP associated with QoL 1 year after acutely decompensated heart failure: secondary analysis from the MOLITOR trial. Biomark Med. 2019 Dec;13(17):1493-1507. doi: 10.2217/bmm-2019-0083. Epub 2019 Oct 29. |
| 29476612 | Derived | Dungen HD, Tscholl V, Obradovic D, Radenovic S, Matic D, Musial Bright L, Tahirovic E, Marx A, Inkrot S, Hashemi D, Veskovic J, Apostolovic S, von Haehling S, Doehner W, Cvetinovic N, Lainscak M, Pieske B, Edelmann F, Trippel T, Loncar G. Prognostic performance of serial in-hospital measurements of copeptin and multiple novel biomarkers among patients with worsening heart failure: results from the MOLITOR study. ESC Heart Fail. 2018 Apr;5(2):288-296. doi: 10.1002/ehf2.12231. Epub 2018 Feb 24. |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D010900 | Pituitary Diseases |
| D004700 | Endocrine System Diseases |