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| Name | Class |
|---|---|
| Philips Technology Aachen Germany | UNKNOWN |
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The aim of the study is to determine the feasibility of collecting respiratory parameters during recompensation following ADHF (Acute Decompensated Heart Failure)with non-invasive measurements. This could lead to a better understanding of how respiratory parameters may change during re-compensation therapy and could also be a comfortable method for patients.
The study is designed as a single-center, open, interventional, observational study according to clause §23b of the German Medical Device Act (MPG). The study will recruit 50 patients suffering from cardiogenic pulmonary congestion and edema including ambulant patients and patients of intensive care.
We will investigate whether respiratory parameters during re-compensation are related to the therapy effects and changes in pulmonary congestion status. This study will collect data in an observational and clinical setting in the re-compensation phase of ADHF.
Correlation between measured lung and respiratory parameters and standard clinical parameters characterizing stages of re-compensation will be undertaken. Standard clinical parameters may include diuretics and other cardiac medication dose frequency, weight, heart rate, respiratory rate, chest x-rays (when routinely performed), symptoms such as shortness of breath or fatigue, biomarkers such as brain natriuretic peptide (BNP), stroke volume, cardiac output, and oxygen requirements.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Respiratory Parameters Measurements | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| non-invasive respiratory parameter measurements | Device |
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| Measure | Description | Time Frame |
|---|---|---|
| Correlation between current standard clinical assessment of re-compensation and measured respiratory parameters | stationary as well as ambulant patients with acute decompensation receive clinical standard measurements and will be measured with the help of non- invasive technology such as respiratory profile and gaz analysis, bioimpedance spectroscopy. Patients will be measured at baseline and 2 times at ward if applicable and at 3 months follow up visit. Measurements will take 1:30 hours per visit. | about 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jörg Schröder, MD | Contact | +4924180 | 89391 | jschröder@ukaachen.de |
| Sigrid Gloeggler, M.Sc. | Contact | +4924180 | 80202 | sgloeggler@ukaachen.de |
| Name | Affiliation | Role |
|---|---|---|
| Jörg Schröder, MD | Department of Cardiology, Pneumology, Angiology and Intensive Care, Internal Medicine I (MK I), University Hospital Aachen (UKA) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Aachen, Department of Cardiology | Recruiting | Aachen | Northrhine-Westfalia | 52074 | Germany |
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