EchoPlus3

• Research type

  Research Study

• Full title

  Improving Pulmonary Congestion Assessment in Heart Failure with Preserved Ejection Fraction\n

• IRAS ID

  290346

• Contact name

  John McMurray

• Contact email

  john.mcmurray@glasgow.ac.uk

• Sponsor organisation

  NHS Greater Glasgow and Clyde

• Clinicaltrials.gov Identifier

  NA, NA

• Duration of Study in the UK

  3 years, 0 months, 1 days

• Research summary

  Research Summary:
  This study aims to understand the importance of findings on lung ultrasound of patients with known heart failure and preserved ejection fraction (HFpEF). This is important as treatment of HFpEF is primarily focused on volume regulation and early detection of congestion to prevent decompensation and hospitalisation. The hypothesis is lung ultrasound is superior to current markers of volume overload and incorporating its use in assessment of patients with HFpEF could improve quality of life and reduce hospitalisations. 600 patients will be involved, with 175 from Queen Elizabeth University Hospital (Glasgow) catchment. All participants will be recruited by a clinical research fellow. There will be two other sites recruiting in Boston and Nashville. Participants will be identified from symptomatic ambulant patients with known or suspected HFpEF attending outpatient services for clinical review or for clinically indicated echocardiogram and have either been hospitalised with heart failure or have an elevated NTproBNP. If eligible, written informed consent will be obtained and participants will undergo an initial study visit. They will have a detailed medical history and physical examination conducted including a record of current symptoms and drug therapies, weight and vital signs. A blood sample will be obtained for NTproBNP, a blood marker of heart failure. Participants will be asked to complete a questionnaire on quality of life and rate their shortness of breath on a scale. An echocardiogram and lung ultrasound will be performed. Virtual follow up of patients by review of clinical notes will inform of subsequent hospital admissions or death.\nThis study will provide vital information regarding prevalence of lung ultrasound changes in patients with HFpEF and how this correlates with echocardiogram finding, quality of life, biomarkers and prognosis. The results will inform the development of a simple clinical congestion risk score which can be used to guide treatment.

  Summary of Results:
  Background
  Heart failure with preserved ejection fraction (HFpEF) is a form of heart failure in which the heart’s pumping ability appears near normal but patients still develop fluid buildup in the lungs (pulmonary congestion). Finding this congestion early in outpatients can help adjust treatment and prevent worsening, but standard exams and tests often miss it.

  What we did
  We examined 415 outpatients with HFpEF (average age 74; about half women; half obese) at several sites. Clinicians used a small, handheld ultrasound to scan eight areas of the lungs and counted “B‑lines,” a visible sign of lung fluid. Heart scans (echocardiograms) and blood tests for a heart failure marker (NT‑proBNP) were analyzed separately and blinded to the ultrasound results.

  Key findings — in simple terms

  B‑lines were found in 78% of patients. The number of B‑lines varied widely (0–36), with a typical value of 3.
  More B‑lines were strongly linked to higher NT‑proBNP levels (a blood marker of heart strain).
  Many patients with many B‑lines had no crackles heard on lung exam (76%) and half did not have elevated NT‑proBNP — meaning traditional checks and blood tests sometimes missed lung congestion.
  More B‑lines were also linked to several important heart ultrasound findings: larger heart chamber sizes, thicker heart muscle, higher filling pressures, more leakage across the tricuspid valve, larger inferior vena cava, and poorer right‑side heart function. B‑lines were not related to the left ventricle’s ejection fraction (pumping percentage).
  What this means for patients and clinicians Handheld lung ultrasound can detect lung fluid in many outpatients with HFpEF, including cases that physical exam or blood tests miss. This suggests lung ultrasound could be a useful, noninvasive tool to identify early congestion and guide treatment before symptoms become severe.
  

• REC name

  South Central - Oxford B Research Ethics Committee

• REC reference

  21/SC/0226

• Date of REC Opinion

  29 Jul 2021

• REC opinion

  Further Information Favourable Opinion