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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
  Purpose

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.


Condition Intervention
Acute Decompensated Heart Failure (ADHF)
Acute Cardiogenic Pulmonary Edema (ACPE)
Device: non-invasive respiratory parameter measurements

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Non-Invasive Pulmonary Monitoring in Patients With Cardiogenic Pulmonary Congestion and Edema

Resource links provided by NLM:


Further study details as provided by RWTH Aachen University:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 50
Study Start Date: June 2013
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Respiratory Parameters Measurements Device: non-invasive respiratory parameter measurements
Other Name: Philips Respironics BiPAP Synchrony, Bioimpedance ImpediMed- SFB7

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01885403

Contacts
Contact: Jörg Schröder, MD +4924180 ext 89391 jschröder@ukaachen.de
Contact: Sigrid Gloeggler, M.Sc. +4924180 ext 80202 sgloeggler@ukaachen.de

Locations
Germany
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    sgloeggler@ukaachen.de   
Principal Investigator: Jörg Schröder, MD         
Sub-Investigator: Alexander Kersten, MD         
Sub-Investigator: Andreas Napp, MD         
Sub-Investigator: Katrin Kersten, MD         
Sponsors and Collaborators
RWTH Aachen University
Philips Technologie GmbH Innovative Technologies
Investigators
Principal Investigator: Jörg Schröder, MD Department of Cardiology, Pneumology, Angiology and Intensive Care, Internal Medicine I (MK I), University Hospital Aachen (UKA)
  More Information

No publications provided

Responsible Party: RWTH Aachen University
ClinicalTrials.gov Identifier: NCT01885403     History of Changes
Other Study ID Numbers: CTC-A 12-117
Study First Received: June 20, 2013
Last Updated: August 10, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by RWTH Aachen University:
Acute Cardiogenic Pulmonary Edema,
Acute Decompensated Heart Failure,
BiLevel Positive Airway Pressure,
Continuous Positive Airway Pressure

Additional relevant MeSH terms:
Edema
Heart Failure
Pulmonary Edema
Cardiovascular Diseases
Heart Diseases
Lung Diseases
Respiratory Tract Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on November 25, 2014