Acute Congestive Heart Failure

Acute Decompensated Heart Failure (ADHF) Clinical Trial

— AcuteCHF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01885403
• Other study ID #: CTC-A 12-117
• Status: Recruiting
• Phase: N/A
• First received: June 20, 2013
• Last updated: September 22, 2015
• Start date: June 2013
• Est. completion date: April 2016

Study information

• Verified date: September 2015
• Source: RWTH Aachen University
• Contact: Jörg Schröder, MD
• Phone: +4924180
• Email: jschröder[@]ukaachen.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: April 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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)

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

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

Intervention

Device:
• non-invasive respiratory parameter measurements

Locations

Country	Name	City	State
Germany	University Hospital of Aachen, Department of Cardiology	Aachen	Northrhine-Westfalia

Sponsors (2)

Lead Sponsor	Collaborator
RWTH Aachen University	Philips Technology Aachen Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes