Decompensated HeartfailureNCT02058810
Nasal High Flow at Acute Hart Failure
A study testing Nasal high flow and Conventional nasal oxygen in people with Decompensated Heartfailure and Cardio-renal Syndrom, run by University Hospital Regensburg at 1 site in Germany.
Trial summary
The pilot study aims to compare the results of using a new respirator (OPTIFLOW TM-High-Flow-Machine) with those from Standard-Oxygen-Therapy during the stabilization of patients who have been hospitalized due to acute heart failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Decompensated Heartfailure, Cardio-renal Syndrom
- What is being tested?
- Nasal high flow and Conventional nasal oxygen
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2010to May 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with acute heartfailure NYHA III und IV
Who cannot join
- Patients wit respiratory insufficency and indication for mechanical ventilation
- Asthma bronchiale
- severe COPD
- cardiogenic shock (RR persisting< 90mmHg systolic or catecholamine application)
- renal dialysis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does the Use of Optiflow High Flow Oxygen on Patients With Acute Cardial Decompensation (NYHA Classification Stage III-IV) Allow for Quicker Improvement of the Organ Dysfunction Than Conventional Standard-Oxygen-Insufflation-Therapy?
The pilot study aims to compare the results of using a new respirator (OPTIFLOW TM-High-Flow-Machine) with those from Standard-Oxygen-Therapy during the stabilization of patients who have been hospitalized due to acute heart failure. We expect a faster and more effective stabilization after acute cardial decompensation among the patients with the High-Flow-machine.
The study should show whether the use of High-Flow-Therapy leads to a relevant improvement in terms of objective clinical parameters of heart failure like those for cardial-renal syndrome, changes in the nt-pro-BNP, weight loss, changes in the diameter of the inferior vena cava, in terms of the degree of shortness of breath and decompensation, and whether subjective clinical symptoms like dyspnea and quality of life differ between the two groups of patients.
Read more
The investigators see the primary outcome of the study as the improvement of the cardial-renal syndrome as a sign of the more effective stabilisation compared to the standard therapy. Furthermore, the investigators expect a quicker decrease in serum creatinine and an improvement in the creatinine clearance through therapy with the High-Flow-Machine. In terms of secondary outcomes of the study, the investigators are interested in also comparing e.g., the duration of hospital stays, 90-day mortality, and rehospitalisation within three months. Here, the investigators expect a quicker improvement in the subjective shortness of breath of the patients who are treated using the Hifh-Flow-Machine. Moreover, we believe that along with the individual subjective improvements (quality of life survey), the patients will experience a quicker release from the hospital and in this way, lead to a healthcare economic improvement among patients with repeated hospitalizations who usually have chronic problems.
It is also of great interest to us, whether the biomarker BNP is an appropriate parameter for determining the faster stabilization of the patient and whether the degree of improvement of subjective dyspnea is correlated with the time needed until the patient has been stabilised.
Read the detailed description
Primary endpoint:
Improvement of the cardiorenal syndrome type1 measured by the improvement of creatine clearance and the Serum-Creatinin of patients undergoing High-Flow treatment.
Secondary endpoints:
Worsening of cardiac insufficiency (application of catecholamines, need of NIV, intubation, death) Duration of hospital stay (in days) 90-day mortality Readmittance to hospital within 3 months Intrathoracic bloodvolume at hospital discharge Change of dyspnea at 3h, 6h, 24h > VAS-0-100 (visual analog scale) Change in the diameter of the IVC (inferior vena cava) as a non-invasive parameter for assessing the degree of decompensation Change in the BNP (hospital admission vs. discharge, after 3 months) Weight loss in hospital Amount of diuretics
- Conditions
- Decompensated Heartfailure, Cardio-renal Syndrom
- Being tested
- Nasal high flow, Conventional nasal oxygen
- Keywords
- nasal high flow oxygen, cardio-renal syndrom, heartfailure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal high flowDevice
Also called Optiflow, Fisher & Paykel Healthcare, RT202
Conventional nasal oxygenDevice
Also called nasal oxygen
| Study group | Role | What they receive |
|---|---|---|
| Conventional nasal Oxygen | Other | Conventional nasal Oxygen as needed Receives: Device: Conventional nasal oxygen |
| Nasal high flow | Other | Nasal high flow therapy with FiO2 40% and flow of 40l/min for at least 48h Receives: Device: Nasal high flow |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiorenal syndrome type 1
The acute deterioration of the cardial situation often leads to a consecutive deterioration of renal function. The damage to renal function caused by acute cardial genesis is defined as cardiorenal syndrome type 1 [2]. In such cases, the venous congestion with heightened central venous pressure leads to disruption of renalfunction and possibly even to acute kidney failure [3, 4]. This is defined as cardiorenal syndrom with an increase in serumcreatine of >0,3 mg/dl and is associated with higher mortality and longer hospital stays [5].
Measured: 3 Months
Secondary outcomes (1)
Change of dyspnea
Change of dyspnea at 3h, 6h, 24h > VAS-0-100 (visual analog scale)
Measured: 3h, 6h, 24h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2014 (estimated)
- Study startSep 2010
- Primary completionMay 2014
- Study completionMay 2014
Why it stopped: Lack of patients, PI left
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Decompensated HeartfailureStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Regensburg
- Sponsor type
- University, hospital or other
- Collaborators
- University of Magdeburg
- Responsible party
- Principal investigator, Maximilian Malfertheiner, University Hospital Regensburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02058810
- Sponsor's protocol ID
- 300513
- Status last verified
- Sep 2019
- First submitted
- 6 Feb 2014
- Last updated
- 26 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Use of Optiflow High Flow Oxygen on Patients With Acute Cardial Decompensation (NYHA Classification Stage III-IV) Allow for Quicker Improvement of the Organ Dysfunction Than Conventional Standard-Oxygen-Insufflation-Therapy?
- ClinicalTrials.gov ID
- NCT02058810
- Acronym / sponsor ID
- 300513
- Conditions
- Decompensated Heartfailure, Cardio-renal Syndrom
- Keywords
- nasal high flow oxygen, cardio-renal syndrom, heartfailure
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of patients, PI left
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University Hospital RegensburgUniversity, hospital or other
- Collaborators
- University of Magdeburg
- Study start
- Sep 2010
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 10 Feb 2014 (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 pilot study aims to compare the results of using a new respirator (OPTIFLOW TM-High-Flow-Machine) with those from Standard-Oxygen-Therapy during the stabilization of patients who have been hospitalized due to acute heart failure. We expect a faster and more effective stabilization after acute cardial decompensation among the patients with the High-Flow-machine.
The study should show whether the use of High-Flow-Therapy leads to a relevant improvement in terms of objective clinical parameters of heart failure like those for cardial-renal syndrome, changes in the nt-pro-BNP, weight loss, changes in the diameter of the inferior vena cava, in terms of the degree of shortness of breath and decompensation, and whether subjective clinical symptoms like dyspnea and quality of life differ between the two groups of patients.
The investigators see the primary outcome of the study as the improvement of the cardial-renal syndrome as a sign of the more effective stabilisation compared to the standard therapy. Furthermore, the investigators expect a quicker decrease in serum creatinine and an improvement in the creatinine clearance through therapy with the High-Flow-Machine. In terms of secondary outcomes of the study, the investigators are interested in also comparing e.g., the duration of hospital stays, 90-day mortality, and rehospitalisation within three months. Here, the investigators expect a quicker improvement in the subjective shortness of breath of the patients who are treated using the Hifh-Flow-Machine. Moreover, we believe that along with the individual subjective improvements (quality of life survey), the patients will experience a quicker release from the hospital and in this way, lead to a healthcare economic improvement among patients with repeated hospitalizations who usually have chronic problems.
It is also of great interest to us, whether the biomarker BNP is an appropriate parameter for determining the faster stabilization of the patient and whether the degree of improvement of subjective dyspnea is correlated with the time needed until the patient has been stabilised.
Detailed description
Primary endpoint:
Improvement of the cardiorenal syndrome type1 measured by the improvement of creatine clearance and the Serum-Creatinin of patients undergoing High-Flow treatment.
Secondary endpoints:
Worsening of cardiac insufficiency (application of catecholamines, need of NIV, intubation, death) Duration of hospital stay (in days) 90-day mortality Readmittance to hospital within 3 months Intrathoracic bloodvolume at hospital discharge Change of dyspnea at 3h, 6h, 24h > VAS-0-100 (visual analog scale) Change in the diameter of the IVC (inferior vena cava) as a non-invasive parameter for assessing the degree of decompensation Change in the BNP (hospital admission vs. discharge, after 3 months) Weight loss in hospital Amount of diuretics
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional nasal Oxygen | Other | Device: Conventional nasal oxygenConventional nasal Oxygen as needed |
| Nasal high flow | Other | Device: Nasal high flowNasal high flow therapy with FiO2 40% and flow of 40l/min for at least 48h |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with acute heartfailure NYHA III und IV
Key exclusion criteria (5 listed)
- Patients wit respiratory insufficency and indication for mechanical ventilation
- Asthma bronchiale
- severe COPD
- cardiogenic shock (RR persisting< 90mmHg systolic or catecholamine application)
- renal dialysis
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 |
|---|---|---|
| Nasal high flowAlso: Optiflow, Fisher & Paykel Healthcare, RT202 | Device | Nasal high flow |
| Conventional nasal oxygenAlso: nasal oxygen | Device | Conventional nasal Oxygen |
Primary outcome
Cardiorenal syndrome type 1
Time frame: 3 Months
The acute deterioration of the cardial situation often leads to a consecutive deterioration of renal function. The damage to renal function caused by acute cardial genesis is defined as cardiorenal syndrome type 1 [2]. In such cases, the venous congestion with heightened central venous pressure leads to disruption of renalfunction and possibly even to acute kidney failure [3, 4]. This is defined as cardiorenal syndrom with an increase in serumcreatine of >0,3 mg/dl and is associated with higher mortality and longer hospital stays [5].
1 secondary outcome
Change of dyspnea
Time frame: 3h, 6h, 24h
Results and safety
The study was stopped early (reason given: Lack of patients, PI left). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2019.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nasal high flow and Conventional nasal oxygen in people with Decompensated Heartfailure and Cardio-renal Syndrom, run by University Hospital Regensburg 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 1 inclusion and 5 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: stopped early, as of the sponsor's last update on 26 Sep 2019. 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?
The study was stopped early (reason given: Lack of patients, PI left). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiorenal syndrome type 1 (time frame: 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 26 Sep 2019.