Bioimpedance Spectroscopy for the Evaluation of Heart Failure (BIS-HF)

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.

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 Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Device: Bioimpedance spectroscopy; Device: Lung Ultrasonography; Device: Echocardiography

• Study Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

• Romania
  • Iaşi, Romania
    • Dr. CI Parhon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with Heart Failure

Description

Inclusion Criteria:

1. age ≥18 years;
2. HF diagnosis regardless of cause as defined by the Framingham criteria and satisfying the European Society of Cardiology guidelines;

Exclusion Criteria:

1. metallic joint prostheses, cardiac stent or pacemakers, decompensated cirrhosis, pregnancy and limb amputations (due to bioimpedance technique limitations);
2. no prior diagnosis of pulmonary fibrosis (due to lung ultrasonography limitations);
3. absence of congenital heart disease

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The relationship between bioimpedance derived parameters (TBW, ICW, ECW, RFO), clinical assessment, lung congestion (as assessed by lung ultrasonography), echocardiography and different cardiac biomarkers.	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
The impact of baseline bioimpedance characteristics (TBW, ICW, ECW, RFO) on all-cause mortality.	2 years
The impact of baseline bioimpedance characteristics (TBW, ICW, ECW, RFO) on fatal and non-fatal cardiovascular events.	2 years
The impact of baseline bioimpedance characteristics (TBW, ICW, ECW, RFO) on hospitalizations.	2 years

Collaborators and Investigators

• Sponsor: Grigore T. Popa University of Medicine and Pharmacy

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Actual): May 1, 2020
• Study Completion (Actual): May 1, 2020

Study Registration Dates

• First Submitted: April 12, 2016
• First Submitted That Met QC Criteria: May 3, 2016
• First Posted (Estimate): May 6, 2016

Study Record Updates

• Last Update Posted (Actual): January 26, 2021
• Last Update Submitted That Met QC Criteria: January 23, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Heart failure; Bioimpedance; Lung ultrasonography
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: BIS-HF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes