Quantifying Congestion by Ultrasound

Not Applicable

• Conditions: Heart Failure
• Interventions: Other: Diuretics

• Registration Number: NCT05090137
• Lead Sponsor: NHS Greater Glasgow and Clyde

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-26
• Status Verified: 2021-10
• Study First Submitted QC: 2021-10-21
• Last Update Submitted: 2021-10-21
• Study First Posted: 2021-10-22
• Last Update Posted: 2021-10-22
• Study Start: 2021-11
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Usual diuretic regimen	Diuretics	Participants will take their usual diuretic regimen prior to study visit. At least one week is required between cross-over visits
Diuretic cessation	Diuretics	Participants will be asked to withhold their diuretic therapy (loop diuretics and mineralocorticoid receptor antagonists) 48 hours prior to visit

Primary Outcome Measures

Name	Time	Method
Differences in ultrasound markers or congestion following continuation or suspension of diuretics for 48 hours.	at baseline	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.

Secondary Outcome Measures

Name	Time	Method
The acute variation in interstitial and intravascular congestion on imaging tests following administration of diuretics.	up to 3 hours	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.
The acute variation in biomarkers of congestion, inflammation and myocardial injury following administration of diuretics.	at 3 hours	The acute variation in biomarkers of congestion (NT-proBNP), inflammation (HsCRP) and myocardial injury (Troponin) following administration of diuretics.

Trial Locations

Locations (1)

NHS Greater Glasgow and Clyde; 🇬🇧 Glasgow, United Kingdom