BioImpedentiometry, Lung UltraSound and cONgestion in Heart Failure

NCT02394470 | Completed

• 1 other identifier: 1246 BLUE MOON
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Congestive Heart Failure

Keywords

congestion; total body water; bioimpedentiometry; lung ultrasound; diuretics; dyspnea; pulmonary B lines; deuterium

Outcome Measures

Primary Outcomes (1)

• Correlation between changes in total body water assessed by deuterium dilution (gold standard) and variations in body resistance by BioImpedentiometry

  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

  Group 1 (AHF): hospital admission and hospital discharge

• execution time of BioImpedentiometry and Lung UltraSound Examination

  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

  Group 1 (AHF): baseline at hospital admission; Group 2 CHF: baseline outpatient visit; Group 3 (ad-CHF) baseline before levosimendan infusion

Study Arms (1)

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

Other: Deuterium oxide dilution; Other: Bioimpedentiometry; Other: Lung and subcutaneous ultrasound

Interventions

Deuterium oxide dilution OTHER

Reference standard for total body water: deuterium oxide dilution by mass spectrometry

Acute heart failure HF,Chronic HF,Advanced chronic HF

Bioimpedentiometry OTHER

Bioimpedentiometry: measurement of whole body and thoracic resistance and reactance

Acute heart failure HF,Chronic HF,Advanced chronic HF

Lung and subcutaneous ultrasound OTHER

Ultrasound: semiquantitative scoring of lung congestion (B lines) and peripheral edema (subcutaneous echography of the ankle)

Acute heart failure HF,Chronic HF,Advanced chronic HF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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
• 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%)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Niguarda Hospital: lead
• Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy: collaborator

Study Sites (1)

Institute of Clinical Physiology National Research Council

Milan, 20162, Italy

Location

Related Publications (1)

• Gargani L, Volpicelli G. How I do it: lung ultrasound. Cardiovasc Ultrasound. 2014 Jul 4;12:25. doi: 10.1186/1476-7120-12-25.

  PMID: 24993976 RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Heart Failure; Dyspnea

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2015
• First Posted: March 20, 2015
• Study Start: January 1, 2016
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: April 24, 2020

Record last verified: 2020-04

Locations

IT (1)