Acute Congestive Heart Failure (AcuteCHF)
|ClinicalTrials.gov Identifier: NCT01885403|
Recruitment Status : Unknown
Verified September 2015 by RWTH Aachen University.
Recruitment status was: Recruiting
First Posted : June 25, 2013
Last Update Posted : September 23, 2015
|Condition or disease||Intervention/treatment||Phase|
|Acute Decompensated Heart Failure (ADHF) Acute Cardiogenic Pulmonary Edema (ACPE)||Device: non-invasive respiratory parameter measurements||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Non-Invasive Pulmonary Monitoring in Patients With Cardiogenic Pulmonary Congestion and Edema|
|Study Start Date :||June 2013|
|Estimated Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||April 2016|
|Experimental: Respiratory Parameters Measurements||
Device: non-invasive respiratory parameter measurements
Other Name: Philips Respironics BiPAP Synchrony, Bioimpedance ImpediMed- SFB7
- Correlation between current standard clinical assessment of re-compensation and measured respiratory parameters [ Time Frame: about 3 months ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01885403
|Contact: Jörg Schröder, MD||+4924180 ext 89391||jschröder@ukaachen.de|
|Contact: Sigrid Gloeggler, M.Sc.||+4924180 ext email@example.com|
|University Hospital of Aachen, Department of Cardiology||Recruiting|
|Aachen, Northrhine-Westfalia, Germany, 52074|
|Contact: Jörg Schröder, MD +4924180 ext 89391 jschröder@ukaachen.de|
|Contact: Sigrid Gloeggler, M.Sc. +4924180 ext 80202 firstname.lastname@example.org|
|Principal Investigator: Jörg Schröder, MD|
|Sub-Investigator: Alexander Kersten, MD|
|Sub-Investigator: Andreas Napp, MD|
|Sub-Investigator: Katrin Kersten, MD|
|Principal Investigator:||Jörg Schröder, MD||Department of Cardiology, Pneumology, Angiology and Intensive Care, Internal Medicine I (MK I), University Hospital Aachen (UKA)|