Acute Decompensated Heart Failure (ADHF)AcuteCHFNCT01885403
Acute Congestive Heart Failure
A study testing non-invasive respiratory parameter measurements in people with Acute Decompensated Heart Failure (ADHF) and Acute Cardiogenic Pulmonary Edema (ACPE), run by RWTH Aachen University at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Decompensated Heart Failure (ADHF), Acute Cardiogenic Pulmonary Edema (ACPE)
- What is being tested?
- non-invasive respiratory parameter measurements
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2013to Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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)
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Hospital of Aachen, Department of Cardiology
Aachen, Northrhine-Westfalia, 52074
Jörg Schröder, MD, +4924180 ext. 89391, jschröder@ukaachen.de
Sigrid Gloeggler, M.Sc., +4924180 ext. 80202, sgloeggler@ukaachen.de
About this study
Official title: Non-Invasive Pulmonary Monitoring in Patients With Cardiogenic Pulmonary Congestion and Edema
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.
- Being tested
- non-invasive respiratory parameter measurements
- Keywords
- Acute Cardiogenic Pulmonary Edema,, Acute Decompensated Heart Failure,, BiLevel Positive Airway Pressure,, Continuous Positive Airway Pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-invasive respiratory parameter measurementsDevice
Also called Philips Respironics BiPAP Synchrony, Bioimpedance ImpediMed- SFB7
| Study group | Role | What they receive |
|---|---|---|
| Respiratory Parameters Measurements | Experimental | Not described Receives: Device: non-invasive respiratory parameter measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: about 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionDec 2015 (estimated)
- Study completionApr 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Decompensated Heart Failure (ADHF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Collaborators
- Philips Technology Aachen Germany
- Responsible party
- Sponsor
- Investigators
- Jörg Schröder, MD, Principal investigator, Department of Cardiology, Pneumology, Angiology and Intensive Care, Internal Medicine I (MK I), University Hospital Aachen (UKA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01885403
- Sponsor's protocol ID
- CTC-A 12-117
- Acronym
- AcuteCHF
- Status last verified
- Sep 2015
- First submitted
- 20 Jun 2013
- Last updated
- 23 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive Pulmonary Monitoring in Patients With Cardiogenic Pulmonary Congestion and Edema
- ClinicalTrials.gov ID
- NCT01885403
- Acronym / sponsor ID
- AcuteCHF / CTC-A 12-117
- Keywords
- Acute Cardiogenic Pulmonary Edema,, Acute Decompensated Heart Failure,, BiLevel Positive Airway Pressure,, Continuous Positive Airway Pressure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Collaborators
- Philips Technology Aachen Germany
- Study start
- Jun 2013
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Apr 2016 (estimated)
- First posted
- 25 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Respiratory Parameters Measurements | Experimental | Device: non-invasive respiratory parameter measurements |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| non-invasive respiratory parameter measurementsAlso: Philips Respironics BiPAP Synchrony, Bioimpedance ImpediMed- SFB7 | Device | Respiratory Parameters Measurements |
Primary outcome
Correlation between current standard clinical assessment of re-compensation and measured respiratory parameters
Time frame: about 3 months
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jörg Schröder, MD principal investigator
Department of Cardiology, Pneumology, Angiology and Intensive Care, Internal Medicine I (MK I), University Hospital Aachen (UKA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing non-invasive respiratory parameter measurements in people with Acute Decompensated Heart Failure (ADHF) and Acute Cardiogenic Pulmonary Edema (ACPE), run by RWTH Aachen University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jörg Schröder, MD (+4924180 ext. 89391, jschröder@ukaachen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between current standard clinical assessment of re-compensation and measured respiratory parameters (time frame: about 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2015.