Quantifying Congestion by Ultrasound

NHS Greater Glasgow and Clyde20 enrolled

Overview

The investigators will determine the feasibility of identifying and quantifying changes in interstitial and intravascular congestion by imaging in participants with heart failure. The investigators will either continue or temporarily suspend both loop diuretics and mineralo-corticoid antagonists (MRA) for 48 hours in participants with heart failure that is both stable and mild and compare measurements of interstitial (B-lines) and intra-vascular fluids (IVC and JV diameter and renal venous flow) by ultrasound and, in a subset of participants without contra-indications, by cardiac MRI.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Heart Failure

Interventions

DiureticsOTHER

As per group descriptions

Eligibility

Sex: ALLMin age: 19 YearsMax age: 100 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Clinical diagnosis of heart failure * Plasma NT-proBNP \>125ng/L or BNP \>35 ng/l * Left ventricular ejection fraction (LVEF) \<50% on prior imaging test * Treated routinely with a daily dose of loop diuretic * Receiving other guideline-indicated therapy for heart failure * Willing to sign the informed consent form * Greater than 18 years of age Exclusion Criteria: * Chronic Kidney Disease Stage 4 or worse (eGFR \<30 mL/min/1.73 m²) * Atrial fibrillation * Significant valve disease (investigators opinion) * Breathlessness or chest pain at rest or minor exertion * Patients unable to lie flat * Patients deemed too unstable to miss treatment with diuretics for 48 hours * Patients taking part in another interventional trial * Any other concomitant condition that in the opinion of the investigator would not allow a safe participation in the study (ie:-pregnancy, significant frailty) * Patients unwilling or unable to consent * For patients willing to undergo MRI; contraindication to MRI including claustrophobia, metalworkers, and intra-orbital or intracranial metal (eg:- stents), and non-MRI compliant device.

Locations (1)

NHS Greater Glasgow and Clyde

Glasgow, United Kingdom

Outcomes

Primary Outcomes

Differences in ultrasound markers or congestion following continuation or suspension of diuretics for 48 hours.

Differences in interstitial (B-lines) and intravascular (IVC and JV diameter, and renal venous flow) congestion by ultrasound in patients with heart failure following continuation or suspension of diuretics for 48 hours.

Time frame: at baseline

Secondary Outcomes

The acute variation in interstitial and intravascular congestion on imaging tests following administration of diuretics.

The acute variation in interstitial (B-lines) and intravascular (inferior vena cava, jugular vein diameter and renal venous flow) congestion on imaging tests following administration of diuretics.

Time frame: up to 3 hours

The acute variation in biomarkers of congestion, inflammation and myocardial injury following administration of diuretics.

The acute variation in biomarkers of congestion (NT-proBNP), inflammation (HsCRP) and myocardial injury (Troponin) following administration of diuretics.

Time frame: at 3 hours

Central Contacts

Pierpaolo Pellicori, MD, FESC

CONTACT

+44 0141 330 4744 pierpaolo.pellicori@glasgow.ac.uk

Data from ClinicalTrials.gov

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