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Status unknownNCT01885403AcuteCHFUpdated Sep 23, 2015

Acute Congestive Heart Failure

An interventional study of non-invasive respiratory parameter measurements in Acute Decompensated Heart Failure (ADHF) and Acute Cardiogenic Pulmonary Edema (ACPE), sponsored by RWTH Aachen University. Status unknown at 1 site in Germany. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2015-09-23.

Sponsored by RWTH Aachen University · Not applicable, Interventional, and Basic science

The sponsor has not verified this record recently (last verified Sep 2015), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study 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 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.

Read the 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.

02

Conditions studied

  • Acute Decompensated Heart Failure (ADHF)
  • Acute Cardiogenic Pulmonary Edema (ACPE)

Keywords

  • Acute Cardiogenic Pulmonary Edema,
  • Acute Decompensated Heart Failure,
  • BiLevel Positive Airway Pressure,
  • Continuous Positive Airway Pressure
03

In context

Pulmonary Edema

138 studies on the registry are indexed under Pulmonary Edema; 24 are open to participants now.

This study's planned enrollment of 50 is below the median of 68 across 72 interventional studies indexed under Pulmonary Edema.

Browse Pulmonary Edema studies →

Lead sponsor

RWTH Aachen University is the lead sponsor of 228 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Respiratory Parameters Measurements

    Device: non-invasive respiratory parameter measurements

Interventions

  • Devicenon-invasive respiratory parameter measurements

    Also known as: Philips Respironics BiPAP Synchrony, Bioimpedance ImpediMed- SFB7

06

What researchers measure

Primary outcomes

  1. Correlation between current standard clinical assessment of re-compensation and measured respiratory parameters

    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.

    Time frame: about 3 months

07

Study locations

1 of 1 sites recruiting
  • University Hospital of Aachen, Department of Cardiology
    Aachen, Northrhine-Westfalia 52074, Germany
    • Jörg Schröder, MD · Contact · jschröder@ukaachen.de · +4924180
    • Sigrid Gloeggler, M.Sc. · Contact · sgloeggler@ukaachen.de · +4924180
    • Jörg Schröder, MD · Principal investigator
    • Alexander Kersten, MD · Sub investigator
    • Andreas Napp, MD · Sub investigator
    • Katrin Kersten, MD · Sub investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 23, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01885403
Lead sponsor
RWTH Aachen University
Collaborators
Philips Technology Aachen Germany
Responsible party
Sponsor
First posted
Jun 25, 2013
Start date
Jun 2013
Primary completion
Dec 2015 (estimated)
Completion
Apr 2016 (estimated)
Last update
Sep 23, 2015

Study contacts

Jörg Schröder, MD
Contact
jschröder@ukaachen.de
+4924180 ext. 89391
Sigrid Gloeggler, M.Sc.
Contact
sgloeggler@ukaachen.de
+4924180 ext. 80202
Jörg Schröder, MD
principal investigator · Department of Cardiology, Pneumology, Angiology and Intensive Care, Internal Medicine I (MK I), University Hospital Aachen (UKA)

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.

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