Congestive Heart FailureBLUEMOONNCT02394470
BioImpedentiometry, Lung UltraSound and cONgestion in Heart Failure
A study testing Deuterium oxide dilution, Bioimpedentiometry and Lung and subcutaneous ultrasound in people with Congestive Heart Failure, run by Niguarda Hospital at 1 site in Italy.
Trial summary
The purpose of this study is to validate non-invasive and user-friendly methods to monitor systemic and pulmonary congestion in heart failure patients. The primary objective is to validate the role of bioimpedentiometry, pulmonary and subcutaneous ultrasound, to assess changes in total body water in patients with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congestive Heart Failure
- What is being tested?
- Deuterium oxide dilution, Bioimpedentiometry and Lung and subcutaneous ultrasound
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2016to Apr 2020
- 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
- Signed informed consent
- Group-specific inclusion criteria:
- Group 1 (Acute Heart Failure - AHF), patient admitted to the hospital for acute heart failure (de-novo or exacerbation of chronic heart failure), who have at least two of the following congestion criteria:
- weight gain ≥ 2 kg over the three days prior to hospitalization
- physical findings or radiographic signs of pulmonary congestion (crackles, semi-orthopnea)
- Hepatomegaly > 2 cm from the arch rib or ascites
Show all 18Show fewer
- jugular turgor or central venous pressure > 10 cm H20
- Ankle swelling
- Group 2 (Chronic Heart Failure - CHF): outpatients with chronic heart failure (CHF) with characters of clinical stability
- No hospitalization in the previous six months
- Symptoms stable for at least 4 weeks
- Oral therapy stable for at least 4 weeks
- No involuntary weight variations greater than 2 kg in the last 4 weeks
- Absence of signs of congestion
- Group 3 (advanced Chronic Heart Failure - ad-CHF) Patients on optimal medical therapy for HF and treated with periodic infusions of levosimendan (every 4 weeks) according to the following criteria
- Systolic dysfunction (LVEF <35%)
- NYHA Class IIIb-IV and/or level INTERMACS 4, 5, 6
- ≥2 admissions or access to the emergency department for acute HF exacerbation in the previous 12 months
Who cannot join
- Uremia in dialysis treatment
- Invasive mechanical ventilation
- Mechanical circulatory support
- Cardiac cachexia defined as weight loss ≥ 5% in the prior 12 months or body mass index <20 kg/m2 and hypoalbuminemia (albumin <3.2 g/dl) or anemia (hemoglobin <12 g/l)
Trial locations and contacts
1 site in 1 country.
Italy1 site
Institute of Clinical Physiology National Research Council
Milan, 20162
About this study
Official title: BioImpedentiometry and Lung UltraSound Examination to MOnitor cONgestion in Heart Failure
The purpose of this study is to validate non-invasive and user-friendly methods to monitor systemic and pulmonary congestion in heart failure patients.
The primary objective is to validate the role of bioimpedentiometry, pulmonary and subcutaneous ultrasound, to assess changes in total body water in patients with heart failure. vs the gold standard technique of deuterium oxide dilution Secondary objectives are
- to evaluate the applicability of bioimpedentiometry, pulmonary and subcutaneous ultrasound to monitor systemic, pulmonary and peripheral district congestion in relation with clinical and laboratory variables; 2)to analyze the organizational issues related to the use of these methods.
Read the detailed description
Increased congestion leads to the clinical manifestation of heart failure (dyspnea, peripheral edema) and is considered the leading cause of hospital admissions and death among patients with HF Preclinical recognition of congestion in HF patients through home monitoring is crucial to prevent acute exacerbations and hospital admissions. Daily body weight, vital signs and fluid balance give only an indirect assessment of the level of congestion.
Deuterium oxide dilution is the non-invasive reference method for total body water assessment.
Bioelectrical impedance analysis (BIA) and chest ultrasound are simple, non-invasive techniques potentially applicable for home monitoring of congestion by non-physicians.
BIA is a noninvasive method for the study of body composition based on the measurement of body electrical resistance; BIA may allow measurement of whole body and segmental, e.g. pulmonary, fluids. However data on the value of BIA for the monitoring of HF patients are still scarce, inconclusive and relative to small cohorts of patients.
Lung ultrasound (LUS) through evaluation of B-lines, reverberation artifacts in the presence of extravascular lung water has been proposed as a semiquantitative tool to assess pulmonary congestion. B lines showed a good correlation with multiple indicators of congestion.
The aim of this study is to validate whole body and segmental BIA and lung ultrasound vs the gold standard deuterium dilution technique to monitor changes in systemic and pulmonary congestion after treatment in the setting of acute heart failure (AHF Group 1) and advanced chronic heart failure (ad-CHF Group 3) using as controls stable chronic heart failure outpatients (CHF Group 2).
Enrolled patients will simultaneously undergo clinical assessment of congestion (weight gain, pulmonary rales, jugular venous pressure, peripheral edema, chest X-ray), routine laboratory, BIA and pulmonary and subcutaneous ultrasound and deuterium administration as follows Group 1 (Acute Heart Failure - AHF) Patients will be assessed within 24 hours of admission for acute heart failure (T0), and at hospital discharge after an average of 10 days (Td).
Group 2 (Chronic Heart Failure - CHF) Patients will be assessed during a programmed outpatient visit (T0) and after 10 ± 3 days (T1).
Group 3 (Advanced Chronic Heart Failure -Ad-CHF) Ad-CHF patients on periodic levosimendan undergo monthly levosimendan infusions in the outpatient clinic. Baseline assessments will be performed the day of levosimendan administration, before infusion start(T0) and after 80 +/- 12 hours, i.e at the peak haemodynamic effect of levosimendan (Tp).
In all patient groups, vital status and hospital admissions or emergency department visits and their cause will be assessed after 6 months by telephone follow-up.
- Conditions
- Congestive Heart Failure
- Being tested
- Deuterium oxide dilution, Bioimpedentiometry, Lung and subcutaneous ultrasound
- Keywords
- congestion, total body water, bioimpedentiometry, lung ultrasound, diuretics, dyspnea, pulmonary B lines, deuterium
- Medical subject headings
- Heart Failure, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deuterium oxide dilutionOther
Reference standard for total body water: deuterium oxide dilution by mass spectrometry
BioimpedentiometryOther
Bioimpedentiometry: measurement of whole body and thoracic resistance and reactance
Lung and subcutaneous ultrasoundOther
Ultrasound: semiquantitative scoring of lung congestion (B lines) and peripheral edema (subcutaneous echography of the ankle)
| Study group | Role | What they receive |
|---|---|---|
| Acute heart failure HF,Chronic HF,Advanced chronic HF | Other | patient admitted to the hospital for acute heart failure (de-novo or exacerbation of chronic heart failure), for Chronic HF and for Advanced chronic heart failure Receives: Other: Deuterium oxide dilution; Other: Bioimpedentiometry; Other: Lung and subcutaneous ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between changes in total body water assessed by deuterium dilution (gold standard) and variations in body resistance by BioImpedentiometry
Measured: Group1 AHF Changes during hospital stay, with an expected average of 10 days; Group2 CHF Changes at 10±3 days from enrolment visit; Group3 ad-CHF Changes at 80±12h after levosimendan infusion from pre-infusion
Secondary outcomes (3)
Number of patients with B-lines documented by Lung Ultrasound who also show clinical evidence of pulmonary congestion, defined as presence of pulmonary rales or congestion by chest Xray, as a Measure of Diagnostic accuracy
Measured: Group 1 (AHF): hospital admission and hospital discharge
execution time of BioImpedentiometry and Lung UltraSound Examination
Measured: Group 1 (AHF): hospital admission; Group 2 CHF: baseline outpatient visits; Group 3 (ad-CHF) baseline before levosimendan infusion
rates of patient refusal to undergo BioImpedentiometry and Lung UltraSound Examination
Measured: Group 1 (AHF): baseline at hospital admission; Group 2 CHF: baseline outpatient visit; Group 3 (ad-CHF) baseline before levosimendan infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2015 (estimated)
- Study startJan 2016
- Primary completionApr 2020
- Study completionApr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Congestive Heart FailureStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Niguarda Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02394470
- Sponsor's protocol ID
- 1246 BLUE MOON
- Acronym
- BLUEMOON
- Status last verified
- Apr 2020
- First submitted
- 19 Feb 2015
- Last updated
- 24 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Gargani L, Volpicelli G. How I do it: lung ultrasound. Cardiovasc Ultrasound. 2014 Jul 4;12:25. doi: 10.1186/1476-7120-12-25.
PubMed 24993976
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BioImpedentiometry and Lung UltraSound Examination to MOnitor cONgestion in Heart Failure
- ClinicalTrials.gov ID
- NCT02394470
- Acronym / sponsor ID
- BLUEMOON / 1246 BLUE MOON
- Conditions
- Congestive Heart Failure
- Keywords
- congestion, total body water, bioimpedentiometry, lung ultrasound, diuretics, dyspnea, pulmonary B lines, deuterium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Niguarda HospitalUniversity, hospital or other
- Collaborators
- Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
- Study start
- Jan 2016 (actual)
- Primary completion
- Apr 2020 (actual)
- Study completion
- Apr 2020 (actual)
- First posted
- 20 Mar 2015 (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 purpose of this study is to validate non-invasive and user-friendly methods to monitor systemic and pulmonary congestion in heart failure patients.
The primary objective is to validate the role of bioimpedentiometry, pulmonary and subcutaneous ultrasound, to assess changes in total body water in patients with heart failure. vs the gold standard technique of deuterium oxide dilution Secondary objectives are
- to evaluate the applicability of bioimpedentiometry, pulmonary and subcutaneous ultrasound to monitor systemic, pulmonary and peripheral district congestion in relation with clinical and laboratory variables; 2)to analyze the organizational issues related to the use of these methods.
Detailed description
Increased congestion leads to the clinical manifestation of heart failure (dyspnea, peripheral edema) and is considered the leading cause of hospital admissions and death among patients with HF Preclinical recognition of congestion in HF patients through home monitoring is crucial to prevent acute exacerbations and hospital admissions. Daily body weight, vital signs and fluid balance give only an indirect assessment of the level of congestion.
Deuterium oxide dilution is the non-invasive reference method for total body water assessment.
Bioelectrical impedance analysis (BIA) and chest ultrasound are simple, non-invasive techniques potentially applicable for home monitoring of congestion by non-physicians.
BIA is a noninvasive method for the study of body composition based on the measurement of body electrical resistance; BIA may allow measurement of whole body and segmental, e.g. pulmonary, fluids. However data on the value of BIA for the monitoring of HF patients are still scarce, inconclusive and relative to small cohorts of patients.
Lung ultrasound (LUS) through evaluation of B-lines, reverberation artifacts in the presence of extravascular lung water has been proposed as a semiquantitative tool to assess pulmonary congestion. B lines showed a good correlation with multiple indicators of congestion.
The aim of this study is to validate whole body and segmental BIA and lung ultrasound vs the gold standard deuterium dilution technique to monitor changes in systemic and pulmonary congestion after treatment in the setting of acute heart failure (AHF Group 1) and advanced chronic heart failure (ad-CHF Group 3) using as controls stable chronic heart failure outpatients (CHF Group 2).
Enrolled patients will simultaneously undergo clinical assessment of congestion (weight gain, pulmonary rales, jugular venous pressure, peripheral edema, chest X-ray), routine laboratory, BIA and pulmonary and subcutaneous ultrasound and deuterium administration as follows Group 1 (Acute Heart Failure - AHF) Patients will be assessed within 24 hours of admission for acute heart failure (T0), and at hospital discharge after an average of 10 days (Td).
Group 2 (Chronic Heart Failure - CHF) Patients will be assessed during a programmed outpatient visit (T0) and after 10 ± 3 days (T1).
Group 3 (Advanced Chronic Heart Failure -Ad-CHF) Ad-CHF patients on periodic levosimendan undergo monthly levosimendan infusions in the outpatient clinic. Baseline assessments will be performed the day of levosimendan administration, before infusion start(T0) and after 80 +/- 12 hours, i.e at the peak haemodynamic effect of levosimendan (Tp).
In all patient groups, vital status and hospital admissions or emergency department visits and their cause will be assessed after 6 months by telephone follow-up.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute heart failure HF,Chronic HF,Advanced chronic HF | Other | Other: Deuterium oxide dilution, Other: Bioimpedentiometry, Other: Lung and subcutaneous ultrasoundpatient admitted to the hospital for acute heart failure (de-novo or exacerbation of chronic heart failure), for Chronic HF and for Advanced chronic heart failure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Signed informed consent
- Group 1 (Acute Heart Failure - AHF), patient admitted to the hospital for acute heart failure (de-novo or exacerbation of chronic heart failure), who have at least two of the following congestion criteria:
- Group 2 (Chronic Heart Failure - CHF): outpatients with chronic heart failure (CHF) with characters of clinical stability
- Group 3 (advanced Chronic Heart Failure - ad-CHF) Patients on optimal medical therapy for HF and treated with periodic infusions of levosimendan (every 4 weeks) according to the following criteria
Key exclusion criteria (4 listed)
- Uremia in dialysis treatment
- Invasive mechanical ventilation
- Mechanical circulatory support
- Cardiac cachexia defined as weight loss ≥ 5% in the prior 12 months or body mass index <20 kg/m2 and hypoalbuminemia (albumin <3.2 g/dl) or anemia (hemoglobin <12 g/l)
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 |
|---|---|---|
| Deuterium oxide dilutionReference standard for total body water: deuterium oxide dilution by mass spectrometry | Other | Acute heart failure HF,Chronic HF,Advanced chronic HF |
| BioimpedentiometryBioimpedentiometry: measurement of whole body and thoracic resistance and reactance | Other | Acute heart failure HF,Chronic HF,Advanced chronic HF |
| Lung and subcutaneous ultrasoundUltrasound: semiquantitative scoring of lung congestion (B lines) and peripheral edema (subcutaneous echography of the ankle) | Other | Acute heart failure HF,Chronic HF,Advanced chronic HF |
Primary outcome
Correlation between changes in total body water assessed by deuterium dilution (gold standard) and variations in body resistance by BioImpedentiometry
Time frame: Group1 AHF Changes during hospital stay, with an expected average of 10 days; Group2 CHF Changes at 10±3 days from enrolment visit; Group3 ad-CHF Changes at 80±12h after levosimendan infusion from pre-infusion
3 secondary outcomes
Number of patients with B-lines documented by Lung Ultrasound who also show clinical evidence of pulmonary congestion, defined as presence of pulmonary rales or congestion by chest Xray, as a Measure of Diagnostic accuracy
Time frame: Group 1 (AHF): hospital admission and hospital discharge
execution time of BioImpedentiometry and Lung UltraSound Examination
Time frame: Group 1 (AHF): hospital admission; Group 2 CHF: baseline outpatient visits; Group 3 (ad-CHF) baseline before levosimendan infusion
rates of patient refusal to undergo BioImpedentiometry and Lung UltraSound Examination
Time frame: Group 1 (AHF): baseline at hospital admission; Group 2 CHF: baseline outpatient visit; Group 3 (ad-CHF) baseline before levosimendan infusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2020.
- Results publication: PubMed 24993976Gargani L, Volpicelli G. How I do it: lung ultrasound. Cardiovasc Ultrasound. 2014 Jul 4;12:25. doi: 10.1186/1476-7120-12-25.
- Related InfoLink provided by the sponsor.
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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.
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 Deuterium oxide dilution, Bioimpedentiometry and Lung and subcutaneous ultrasound in people with Congestive Heart Failure, run by Niguarda Hospital at 1 site in Italy.
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 18 inclusion and 4 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: finished, as of the sponsor's last update on 24 Apr 2020. 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 Italy. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Correlation between changes in total body water assessed by deuterium dilution (gold standard) and variations in body resistance by BioImpedentiometry (time frame: Group1 AHF Changes during hospital stay, with an expected average of 10 days; Group2 CHF Changes at 10±3 days from enrolment visit; Group3 ad-CHF Changes at 80±12h after levosimendan infusion from pre-infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02394470, which also lists 1 linked publication.
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 24 Apr 2020.