Charité Campus Virchow Klinikum-Medizinische Klinik mit Schwerpunkt Kardiologie
Berlin, 13353, Germany
NCT Number: NCT01501981
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:
1. To evaluate the impact of guideline-recommended medication on biomarker levels during and following recompensation. 2. To evaluate whether the trajectory of relevant biomarkers (MR-proANP, MR-proADM) is of relevance to guide medical therapy following decompensation. 3. To evaluate whether the degree of biomarker change (e.g. slow versus rapid change) is of relevance with regard to hemodynamic stability and cardiovascular events such as hospitalisation. 4. To evaluate whether the trajectory of relevant biomarkers (copeptin, CT-pro-ET1) is of relevance to guide medical therapy following decompensation.
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Notify Me18 year and older
All sexes
Observational
Berlin, 13353, Germany
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: from study start (day 1) during hosptialisation until second year of follow up
Time to first event
Time frame: from study start (day 1) during hosptialisation until second year of follow up
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.
Time frame: from study start (day 1) during hosptialisation until second year of follow up
Six-minute walk test distance will be performed at Visit 1-6 a s well as Follow-up after first and second year.
Time frame: from study start (day 1) during hosptialisation until second year of follow up
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.
Charite University, Berlin, Germany
Other
Impact of Therapy Optimization on the Level of Biomarkers in Patients With Acute Decompensated and Decompensated Chronic Heart Failure
Acronym: MOLITOR
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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