Heart FailureBIS-HFNCT02764073
Bioimpedance Spectroscopy for the Evaluation of Heart Failure
An observational study of Heart Failure, run by Grigore T. Popa University of Medicine and Pharmacy at 1 site in Romania.
Trial summary
Despite impressive improvements in treatment strategies, heart failure (HF) morbidity and mortality remains substantially high worldwide. Pulmonary congestion is considered the leading cause for hospital admissions and death among patients with HF. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Bioimpedance spectroscopy, Lung Ultrasonography and Echocardiography
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 1 siteRomania
- Study dates
- May 2016to May 2020
- Phase
- Observational
- 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
Study population: Patients with Heart Failure
Who may be able to join
- age ≥18 years;
- HF diagnosis regardless of cause as defined by the Framingham criteria and satisfying the European Society of Cardiology guidelines;
Who cannot join
- metallic joint prostheses, cardiac stent or pacemakers, decompensated cirrhosis, pregnancy and limb amputations (due to bioimpedance technique limitations);
- no prior diagnosis of pulmonary fibrosis (due to lung ultrasonography limitations);
- absence of congenital heart disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bioimpedance Spectroscopy for the Evaluation of Heart Failure - a Comparison With Clinical Assessment, Lung Ultrasonography, Cardiac Biomarkers and Echocardiography
Despite impressive improvements in treatment strategies, heart failure (HF) morbidity and mortality remains substantially high worldwide. Pulmonary congestion is considered the leading cause for hospital admissions and death among patients with HF. Physical examination is crucial for titrating medical treatment in these patients, but despite a good specificity it is not sensitive enough to detect early elevated cardiac filling pressures.
The N-terminal pro-B-type natriuretic peptide (NT-proBNP) is a recognized powerful predictor for HF prognosis. Recently, cardiotrophin-1 and galectin-3 have been proposed as new relevant biomarkers for HF evaluation.
Read more
Echocardiography can be also used to noninvasively measure left ventricular filling pressures. Lung ultrasound (LUS) through interstitial B-line evaluation has been recently proposed as a bed-side, noninvasive tool to assess interstitial lung water. B-lines correlate with NT-proBNP and E/e' levels in patients with acute dyspnea, chronic HF or after a stress test. LUS can also identify clinically silent pulmonary edema, suggesting that it may complement clinical evaluation to improve hemodynamic profiling and treatment optimization.
Biompedance is a bedside method for total body fluid status assessment. It defines individual fluid status/compartments/overload on the basis of an individual's normal extracellular volume and body composition. Recent studies indicate that bioimpedance-derived fluid overload indices are independent predictors of mortality in renal failure patients.
To date, no study has evaluated bioimpedance performance for fluid assessment in HF patients. The investigators aim to cross-sectionally compare bioimpedance parameters with clinical evaluation, LUS, cardiac biomarkers, and echocardiographic characteristics, in a cohort of incident consecutive patients with HF. Two years patients' survival will be evaluated to propose the best evaluative algorithm and rank the various methods for prognostic significance.
- Conditions
- Heart Failure
- Being tested
- Bioimpedance spectroscopy, Lung Ultrasonography, Echocardiography
- Keywords
- Heart failure, Bioimpedance, Lung ultrasonography
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bioimpedance spectroscopyDevice
Also called BCM®Body Composition Monitor - Fresenius Medical Care D GmbH
The technique involves attaching electrodes to the patient's forearm and ipsilateral ankle, with the patient in a supine position. The BCM® measures the body resistance and reactance to electrical currents of 50 discrete frequencies, ranging between 5 and 1000 kHz. Based on a fluid model using these resistances, the extracellular water (ECW), the intracellular water (ICW) and the total body water (TBW) are calculated. All calculations are automatically performed by the software of the BCM® device. Absolute fluid overload (AFO) is is defined as the difference between the expected patient's ECW under normal physiological conditions and the actual ECW, whereas the relative fluid overload (RFO) is defined as the absolute fluid overload AFO to ECW ratio.
Lung UltrasonographyDevice
Examinations will be performed in the supine position. Scanning of the anterior and lateral chest will be performed on both sides of the chest, from the second to the fourth (on the right side to the fifth) intercostal spaces, at parasternal to mid-axillary lines. B-lines will be recorded in each intercostal space and were defined as a hyperechoic, coherent US bundle at narrow basis going from the transducer to the limit of the screen. B-lines starting from the pleural line can be either localized or scattered to the whole lung and be present as isolated or multiple artifacts (with a distance 7 mm between 2 artifacts). The sum of B-lines produces a score reflecting the extent of lung water accumulation (0 being no detectable B-line).
EchocardiographyDevice
All echocardiographic measurements will be carried out according to the recommendations of the American Society of Echocardiography by an observer unaware of the lung ultrasound and bioimpedance results. Echocardiographic evaluation will provide information about cardiac anatomy (e.g. volumes, geometry, mass) and function (e.g. left ventricular function and wall motion, valvular function, right ventricular function, pulmonary artery pressure, pericardium).
What is being measured
The primary outcome is the main question the study is designed to answer.
The relationship between bioimpedance derived parameters (TBW, ICW, ECW, RFO), clinical assessment, lung congestion (as assessed by lung ultrasonography), echocardiography and different cardiac biomarkers.
Measured: 2 years
Secondary outcomes (3)
The impact of baseline bioimpedance characteristics (TBW, ICW, ECW, RFO) on all-cause mortality.
Measured: 2 years
The impact of baseline bioimpedance characteristics (TBW, ICW, ECW, RFO) on fatal and non-fatal cardiovascular events.
Measured: 2 years
The impact of baseline bioimpedance characteristics (TBW, ICW, ECW, RFO) on hospitalizations.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2016 (estimated)
- Study startMay 2016
- Primary completionMay 2020
- Study completionMay 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 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grigore T. Popa University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Adrian Covic, Grigore T. Popa University of Medicine and Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02764073
- Sponsor's protocol ID
- BIS-HF
- Acronym
- BIS-HF
- Status last verified
- Jan 2021
- First submitted
- 12 Apr 2016
- Last updated
- 26 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
Siriopol D, Popa R, Mihaila M, Rusu F, Sascau R, Statescu C, Catalina Z, Vasiliu V, Bucur A, Neamtu A, Siriopol I, Cianga P, Kanbay M, Covic A. Application of survival classification and regression tree analysis for identification of subgroups of risk in patients with heart failure and reduced left ventricular ejection fraction. Int J Cardiovasc Imaging. 2021 Jun;37(6):1853-1861. doi: 10.1007/s10554-021-02159-6. Epub 2021 Jan 16.
PubMed 33454896
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioimpedance Spectroscopy for the Evaluation of Heart Failure - a Comparison With Clinical Assessment, Lung Ultrasonography, Cardiac Biomarkers and Echocardiography
- ClinicalTrials.gov ID
- NCT02764073
- Acronym / sponsor ID
- BIS-HF / BIS-HF
- Conditions
- Heart Failure
- Keywords
- Heart failure, Bioimpedance, Lung ultrasonography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Grigore T. Popa University of Medicine and PharmacyUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- May 2020 (actual)
- Study completion
- May 2020 (actual)
- First posted
- 6 May 2016 (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.
Despite impressive improvements in treatment strategies, heart failure (HF) morbidity and mortality remains substantially high worldwide. Pulmonary congestion is considered the leading cause for hospital admissions and death among patients with HF. Physical examination is crucial for titrating medical treatment in these patients, but despite a good specificity it is not sensitive enough to detect early elevated cardiac filling pressures.
The N-terminal pro-B-type natriuretic peptide (NT-proBNP) is a recognized powerful predictor for HF prognosis. Recently, cardiotrophin-1 and galectin-3 have been proposed as new relevant biomarkers for HF evaluation.
Echocardiography can be also used to noninvasively measure left ventricular filling pressures. Lung ultrasound (LUS) through interstitial B-line evaluation has been recently proposed as a bed-side, noninvasive tool to assess interstitial lung water. B-lines correlate with NT-proBNP and E/e' levels in patients with acute dyspnea, chronic HF or after a stress test. LUS can also identify clinically silent pulmonary edema, suggesting that it may complement clinical evaluation to improve hemodynamic profiling and treatment optimization.
Biompedance is a bedside method for total body fluid status assessment. It defines individual fluid status/compartments/overload on the basis of an individual's normal extracellular volume and body composition. Recent studies indicate that bioimpedance-derived fluid overload indices are independent predictors of mortality in renal failure patients.
To date, no study has evaluated bioimpedance performance for fluid assessment in HF patients. The investigators aim to cross-sectionally compare bioimpedance parameters with clinical evaluation, LUS, cardiac biomarkers, and echocardiographic characteristics, in a cohort of incident consecutive patients with HF. Two years patients' survival will be evaluated to propose the best evaluative algorithm and rank the various methods for prognostic significance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Heart Failure
Key inclusion criteria (2 listed)
- age ≥18 years;
- HF diagnosis regardless of cause as defined by the Framingham criteria and satisfying the European Society of Cardiology guidelines;
Key exclusion criteria (3 listed)
- metallic joint prostheses, cardiac stent or pacemakers, decompensated cirrhosis, pregnancy and limb amputations (due to bioimpedance technique limitations);
- no prior diagnosis of pulmonary fibrosis (due to lung ultrasonography limitations);
- absence of congenital heart disease
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 |
|---|---|---|
| Bioimpedance spectroscopyAlso: BCM®Body Composition Monitor - Fresenius Medical Care D GmbHThe technique involves attaching electrodes to the patient's forearm and ipsilateral ankle, with the patient in a supine position. The BCM® measures the body resistance and reactance to electrical currents of 50 discrete frequencies, ranging between 5 and 1000 kHz. Based on a fluid model using these resistances, the extracellular water (ECW), the intracellular water (ICW) and the total body water (TBW) are calculated. All calculations are automatically performed by the software of the BCM® device. Absolute fluid overload (AFO) is is defined as the difference between the expected patient's ECW under normal physiological conditions and the actual ECW, whereas the relative fluid overload (RFO) is defined as the absolute fluid overload AFO to ECW ratio. | Device | – |
| Lung UltrasonographyExaminations will be performed in the supine position. Scanning of the anterior and lateral chest will be performed on both sides of the chest, from the second to the fourth (on the right side to the fifth) intercostal spaces, at parasternal to mid-axillary lines. B-lines will be recorded in each intercostal space and were defined as a hyperechoic, coherent US bundle at narrow basis going from the transducer to the limit of the screen. B-lines starting from the pleural line can be either localized or scattered to the whole lung and be present as isolated or multiple artifacts (with a distance 7 mm between 2 artifacts). The sum of B-lines produces a score reflecting the extent of lung water accumulation (0 being no detectable B-line). | Device | – |
| EchocardiographyAll echocardiographic measurements will be carried out according to the recommendations of the American Society of Echocardiography by an observer unaware of the lung ultrasound and bioimpedance results. Echocardiographic evaluation will provide information about cardiac anatomy (e.g. volumes, geometry, mass) and function (e.g. left ventricular function and wall motion, valvular function, right ventricular function, pulmonary artery pressure, pericardium). | Device | – |
Primary outcome
The relationship between bioimpedance derived parameters (TBW, ICW, ECW, RFO), clinical assessment, lung congestion (as assessed by lung ultrasonography), echocardiography and different cardiac biomarkers.
Time frame: 2 years
3 secondary outcomes
The impact of baseline bioimpedance characteristics (TBW, ICW, ECW, RFO) on all-cause mortality.
Time frame: 2 years
The impact of baseline bioimpedance characteristics (TBW, ICW, ECW, RFO) on fatal and non-fatal cardiovascular events.
Time frame: 2 years
The impact of baseline bioimpedance characteristics (TBW, ICW, ECW, RFO) on hospitalizations.
Time frame: 2 years
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 26 Jan 2021.
- Derived from this study: PubMed 33454896Siriopol D, Popa R, Mihaila M, Rusu F, Sascau R, Statescu C, Catalina Z, Vasiliu V, Bucur A, Neamtu A, Siriopol I, Cianga P, Kanbay M, Covic A. Application of survival classification and regression tree analysis for identification of subgroups of risk in patients with heart failure and reduced left ventricular ejection fraction. Int J Cardiovasc Imaging. 2021 Jun;37(6):1853-1861. doi: 10.1007/s10554-021-02159-6. Epub 2021 Jan 16.
- Individual participant dataSharing planned: Yes
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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?
An observational study of Heart Failure, run by Grigore T. Popa University of Medicine and Pharmacy at 1 site in Romania.
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 2 inclusion and 3 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 26 Jan 2021. 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 Romania. 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?
The relationship between bioimpedance derived parameters (TBW, ICW, ECW, RFO), clinical assessment, lung congestion (as assessed by lung ultrasonography), echocardiography and different cardiac biomarkers. (time frame: 2 years). 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 NCT02764073, 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 26 Jan 2021; AzTrials last refreshed its copy on 7 Nov 2026.