Acute Congestive Heart Failure (AcuteCHF)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by RWTH Aachen University
Sponsor:
Collaborator:
Philips Technologie GmbH Innovative Technologies
Information provided by (Responsible Party):
RWTH Aachen University
ClinicalTrials.gov Identifier:
NCT01885403
First received: June 20, 2013
Last updated: August 10, 2013
Last verified: August 2013

June 20, 2013
August 10, 2013
June 2013
October 2014   (final data collection date for primary outcome measure)
Correlation between current standard clinical assessment of re-compensation and measured respiratory parameters [ Time Frame: about 3 months ] [ Designated as safety issue: Yes ]
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.
Correlation between current standard clinical assessment of re-compensation and measured respiratory parameters [ Time Frame: about 3 months ] [ Designated as safety issue: Yes ]
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 inductance plethysmography, respiratory profile and gaz analysis, bioimpedance spectroscopy, lung diffusion and lung mechanics non- invasive devices. 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.
Complete list of historical versions of study NCT01885403 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Acute Congestive Heart Failure
Non-Invasive Pulmonary Monitoring in Patients With Cardiogenic Pulmonary Congestion and Edema

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
  • Acute Decompensated Heart Failure (ADHF)
  • Acute Cardiogenic Pulmonary Edema (ACPE)
Device: non-invasive respiratory parameter measurements
Other Name: Philips Respironics BiPAP Synchrony, Bioimpedance ImpediMed- SFB7
Experimental: Respiratory Parameters Measurements
Intervention: Device: non-invasive respiratory parameter measurements
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
October 2014
October 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Males and females, ages 18-75
  2. Able and willing to provide written informed consent or not able to give informed consent because of mechanical respiration
  3. Diagnosis of acute or chronic decompensated heart failure with pulmonary congestion or edema
  4. Systolic blood pressure >80 mm Hg at time of enrollment
  5. Resting pulse oximetry (SpO2) at the time of enrollment of at least 88% at 21% iron oxides (FeO2)
  6. Agreement to be measured with the study devices according to study protocol by patient or legal representative
  7. Left ventricular ejection fraction (LVEF) < 40% in 3D- Echocardiography

Exclusion Criteria:

  1. Active participation in another interventional research study
  2. Surgery of the upper airway, nose, sinus or middle ear within the last 90 days
  3. 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
  4. Unable to use PAP therapies due to physical issues (e.g. facial structural abnormalities) or cognitive issues (e.g. dementia)
  5. Participants in whom positive airway pressure (PAP) therapy is medically contraindicated.
  6. Uncontrolled hypertension (systolic ≥200 mm Hg/diastolic ≥120 mm Hg)
  7. Pregnancy
  8. Lactation
  9. Implanted pacemaker / Cardiac Resynchronization Therapy (CRT) / implantable cardioverter-defibrillator (ICD) except for Medtronic devices with Opti Vol Algorithm
  10. Incompetent patients or patients who, in the judgment of the investigator, are too unstable or are otherwise not capable of performing study procedures
  11. Post-partum cardiomyopathy
  12. Hypertrophic
  13. Primary mitral valve stenosis
  14. Patients requiring more than 50% supplemental oxygen or patients requiring more than 4 lpm oxygen
  15. Patients with persistent ventricular arrhythmias (Premature ventricular coupling, periods of ventricular tachycardia)
  16. Patients chronically classified (prior to admission) as New York Heart Association (NYHA) Class IV or American Heart Association Class D heart failure
  17. Patients with glomerular filtration rate (GFR) <30 or obligatory dialysis
  18. Resting respiratory rate >30 breaths per minute
  19. Patients requiring mechanical ventilation or patients with an artificial airway (endotracheal or tracheostomy tube)
  20. Patients with carbon monoxide toxicity
  21. 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)
Both
18 Years to 75 Years
No
Contact: Jörg Schröder, MD +4924180 ext 89391 jschröder@ukaachen.de
Contact: Sigrid Gloeggler, M.Sc. +4924180 ext 80202 sgloeggler@ukaachen.de
Germany
 
NCT01885403
CTC-A 12-117
No
RWTH Aachen University
RWTH Aachen University
Philips Technologie GmbH Innovative Technologies
Principal Investigator: Jörg Schröder, MD Department of Cardiology, Pneumology, Angiology and Intensive Care, Internal Medicine I (MK I), University Hospital Aachen (UKA)
RWTH Aachen University
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP