- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01885403
Acute Congestive Heart Failure (AcuteCHF)
Non-Invasive Pulmonary Monitoring in Patients With Cardiogenic Pulmonary Congestion and Edema
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Northrhine-Westfalia
-
Aachen, Northrhine-Westfalia, Germany, 52074
- Recruiting
- University Hospital of Aachen, Department of Cardiology
-
Contact:
- Jörg Schröder, MD
- Phone Number: 89391 +4924180
- Email: jschröder@ukaachen.de
-
Contact:
- Sigrid Gloeggler, M.Sc.
- Phone Number: 80202 +4924180
- Email: sgloeggler@ukaachen.de
-
Principal Investigator:
- Jörg Schröder, MD
-
Sub-Investigator:
- Alexander Kersten, MD
-
Sub-Investigator:
- Andreas Napp, MD
-
Sub-Investigator:
- Katrin Kersten, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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 Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Respiratory Parameters Measurements
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
about 3 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jörg Schröder, MD, Department of Cardiology, Pneumology, Angiology and Intensive Care, Internal Medicine I (MK I), University Hospital Aachen (UKA)
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CTC-A 12-117
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Acute Decompensated Heart Failure (ADHF)
-
Nuwellis, Inc.TerminatedHeart Failure | Cardiac Failure | Acute Decompensated Heart Failure (ADHF)United States
-
Aventyn, Inc.Arizona State University; Intel Corporation; TwinEpidemic; Heart Health Organization...RecruitingHeart Failure | ADHF | Acute MIUnited States
-
Medical University of WarsawMedical University of Graz; Medical University of Vienna; Poznan University of... and other collaboratorsRecruitingAcute Decompensated Heart FailurePoland
-
Yooyoung Pharmaceutical Co., Ltd.RecruitingAcute Decompensated Heart FailureKorea, Republic of
-
Cardionomic Inc.Completed
-
Scripps HealthWithdrawnAcute Decompensated Heart FailureUnited States
-
Christian SchulzeBoehringer Ingelheim; Zentrum für Klinische Studien JenaCompletedAcute Decompensated Heart FailureGermany
-
Wake Forest University Health SciencesNational Institute on Aging (NIA)CompletedAcute Decompensated Heart FailureUnited States
-
Prof. Dr. Jörg LeuppiCompletedAcute Decompensated Heart FailureSwitzerland
-
Byung-Hee OhNational Institute of Health, KoreaCompletedAcute Decompensated Heart FailureKorea, Republic of
Clinical Trials on non-invasive respiratory parameter measurements
-
University of California, Los AngelesEnrolling by invitationPulmonary Disease | Pulmonary Embolism | Pulmonary Embolus/Emboli | Pulmonary Embolism and Thrombosis | Pulmonary Embolism Subacute Massive | Pulmonary Embolism Acute MassiveUnited States
-
CareTaker Medical LLCUniversity of Virginia; Yale School of Medicine; Orange County Research CenterCompletedBlood Pressure | Heart Rate Variability | Cardiac Output | Left Ventricular Ejection TimeUnited States
-
University of California, Los AngelesEnrolling by invitationPulmonary Arterial Hypertension | Chronic Thromboembolic Pulmonary HypertensionUnited States
-
Centre Hospitalier Universitaire de Saint EtienneCompleted
-
Medstar Health Research InstituteActive, not recruitingBurn Scar | ScarUnited States
-
Pierre Fabre Dermo CosmetiqueCompletedAtopic DermatitisFrance
-
Centre Hospitalier Régional d'OrléansCompletedHypertension | Intensive Care Unit | Hypotension and ShockFrance
-
University of Colorado, DenverColorado Clinical & Translational Sciences InstituteCompleted
-
McMaster Children's HospitalThe Physicians' Services Incorporated Foundation; Hamilton Academic Health... and other collaboratorsRecruitingBronchopulmonary Dysplasia | Preterm Infant | Respiratory Insufficiency Syndrome of NewbornCanada
-
Institut universitaire de cardiologie et de pneumologie...RecruitingAortic Valve Stenosis | Prosthesis Failure | Aortic Valve RegurgitationCanada