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Acute Congestive Heart Failure (AcuteCHF)

Primary Purpose

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

Status

Unknown status

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

non-invasive respiratory parameter measurements

About this trial

This is an interventional basic science trial for Acute Decompensated Heart Failure (ADHF) focused on measuring Acute Cardiogenic Pulmonary Edema,, Acute Decompensated Heart Failure,, BiLevel Positive Airway Pressure,, Continuous Positive Airway Pressure

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

University Hospital of Aachen, Department of CardiologyRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Respiratory Parameters Measurements

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01885403

First Posted

June 20, 2013

Last Updated

September 22, 2015

Sponsor

RWTH Aachen University

Collaborators

Philips Technology Aachen Germany

1. Study Identification

Unique Protocol Identification Number

NCT01885403

Brief Title

Acute Congestive Heart Failure

Acronym

AcuteCHF

Official Title

Non-Invasive Pulmonary Monitoring in Patients With Cardiogenic Pulmonary Congestion and Edema

Study Type

Interventional

2. Study Status

Record Verification Date

September 2015

Overall Recruitment Status

Unknown status

Study Start Date

June 2013 (undefined)

Primary Completion Date

December 2015 (Anticipated)

Study Completion Date

April 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

RWTH Aachen University

Collaborators

Philips Technology Aachen Germany

4. Oversight

Data Monitoring Committee

5. Study Description

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 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Respiratory Parameters Measurements

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

non-invasive respiratory parameter measurements

Other Intervention Name(s)

Philips Respironics BiPAP Synchrony, Bioimpedance ImpediMed- SFB7

Primary Outcome Measure Information:

Title

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

Description

Time Frame

about 3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jörg Schröder, MD

Phone

+4924180

Ext

89391

jschröder@ukaachen.de

First Name & Middle Initial & Last Name or Official Title & Degree

Sigrid Gloeggler, M.Sc.

Phone

+4924180

Ext

80202

sgloeggler@ukaachen.de

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jörg Schröder, MD

Organizational Affiliation

Department of Cardiology, Pneumology, Angiology and Intensive Care, Internal Medicine I (MK I), University Hospital Aachen (UKA)

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospital of Aachen, Department of Cardiology

City

Aachen

State/Province

Northrhine-Westfalia

ZIP/Postal Code

52074

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jörg Schröder, MD

Phone

+4924180

Ext

89391

jschröder@ukaachen.de

First Name & Middle Initial & Last Name & Degree

Sigrid Gloeggler, M.Sc.

Phone

+4924180

Ext

80202

sgloeggler@ukaachen.de

First Name & Middle Initial & Last Name & Degree

Jörg Schröder, MD

First Name & Middle Initial & Last Name & Degree

Alexander Kersten, MD

First Name & Middle Initial & Last Name & Degree

Andreas Napp, MD

First Name & Middle Initial & Last Name & Degree

Katrin Kersten, MD

12. IPD Sharing Statement

Learn more about this trial

Acute Congestive Heart Failure

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