Status:
UNKNOWN
Acute Congestive Heart Failure
Lead Sponsor:
RWTH Aachen University
Collaborating Sponsors:
Philips Technology Aachen Germany
Conditions:
Acute Decompensated Heart Failure (ADHF)
Acute Cardiogenic Pulmonary Edema (ACPE)
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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 c...
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 c...
Eligibility Criteria
Inclusion
- Males and females, ages 18-75
- Able and willing to provide written informed consent or not able to give informed consent because of mechanical respiration
- Diagnosis of acute or chronic decompensated heart failure with pulmonary congestion or edema
- Systolic blood pressure \>80 mm Hg at time of enrollment
- Resting pulse oximetry (SpO2) at the time of enrollment of at least 88% at 21% iron oxides (FeO2)
- Agreement to be measured with the study devices according to study protocol by patient or legal representative
- Left ventricular ejection fraction (LVEF) \< 40% in 3D- Echocardiography
Exclusion
- Active participation in another interventional research study
- Surgery of the upper airway, nose, sinus or middle ear within the last 90 days
- Major medical or psychiatric condition that would interfere with the demands of the study or the ability to complete the study. For example, severe unstable chronic lung disease such as obstructive (FEV1/FVC ≤ 30%), or restrictive (FVC \< 50% predicted) lung disease, neuromuscular disease, cancer, or renal failure
- Unable to use PAP therapies due to physical issues (e.g. facial structural abnormalities) or cognitive issues (e.g. dementia)
- Participants in whom positive airway pressure (PAP) therapy is medically contraindicated.
- Uncontrolled hypertension (systolic ≥200 mm Hg/diastolic ≥120 mm Hg)
- Pregnancy
- Lactation
- Implanted pacemaker / Cardiac Resynchronization Therapy (CRT) / implantable cardioverter-defibrillator (ICD) except for Medtronic devices with Opti Vol Algorithm
- Incompetent patients or patients who, in the judgment of the investigator, are too unstable or are otherwise not capable of performing study procedures
- Post-partum cardiomyopathy
- Hypertrophic
- Primary mitral valve stenosis
- Patients requiring more than 50% supplemental oxygen or patients requiring more than 4 lpm oxygen
- Patients with persistent ventricular arrhythmias (Premature ventricular coupling, periods of ventricular tachycardia)
- Patients chronically classified (prior to admission) as New York Heart Association (NYHA) Class IV or American Heart Association Class D heart failure
- Patients with glomerular filtration rate (GFR) \<30 or obligatory dialysis
- Resting respiratory rate \>30 breaths per minute
- Patients requiring mechanical ventilation or patients with an artificial airway (endotracheal or tracheostomy tube)
- Patients with carbon monoxide toxicity
- Patients with severe sepsis (defined as also an organ dysfunction due to an infection according to the Guidelines of the German Association of Sepsis, February 2010)
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2016
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01885403
Start Date
June 1 2013
End Date
April 1 2016
Last Update
September 23 2015
Active Locations (1)
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1
University Hospital of Aachen, Department of Cardiology
Aachen, Northrhine-Westfalia, Germany, 52074