Acute Congestive Heart Failure

NCT01885403 | Unknown

• 1 other identifier: CTC-A 12-117
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

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.

  about 3 months

Study Arms (1)

Respiratory Parameters Measurements

EXPERIMENTAL

Device: non-invasive respiratory parameter measurements

Interventions

non-invasive respiratory parameter measurements DEVICE

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

Respiratory Parameters Measurements

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• RWTH Aachen University: lead
• Philips Technology Aachen Germany: collaborator

Study Sites (1)

University Hospital of Aachen, Department of Cardiology

Aachen, Northrhine-Westfalia, 52074, Germany

RECRUITING

Study Officials

• Jörg Schröder, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jörg Schröder, MD

CONTACT

+4924180; jschröder@ukaachen.de

Sigrid Gloeggler, M.Sc.

CONTACT

+4924180; sgloeggler@ukaachen.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2013
• First Posted: June 25, 2013
• Study Start: June 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: April 1, 2016
• Last Updated: September 23, 2015

Record last verified: 2015-09

Locations

DE (1)