Trials / Unknown
UnknownNCT01885403
Acute Congestive Heart Failure
Non-Invasive Pulmonary Monitoring in Patients With Cardiogenic Pulmonary Congestion and Edema
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- Sponsor
- RWTH Aachen University · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | non-invasive respiratory parameter measurements |
Timeline
- Start date
- 2013-06-01
- Primary completion
- 2015-12-01
- Completion
- 2016-04-01
- First posted
- 2013-06-25
- Last updated
- 2015-09-23
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT01885403. Inclusion in this directory is not an endorsement.