Quantifying Congestion by Ultrasound (QUEST-HF)

Quantifying Interstitial and Intravascular Fluid Accumulation by Ultrasound Following Temporary Suspension of Loop Diuretics in Patients With Heart Failure

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 Overview

• Status: Not yet recruiting
• Conditions: Heart Failure
• Intervention / Treatment: Other: Diuretics

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pierpaolo Pellicori, MD, FESC; Phone Number: +44 0141 330 4744; Email: pierpaolo.pellicori@glasgow.ac.uk

Study Locations

• United Kingdom
  • Glasgow, United Kingdom
    • NHS Greater Glasgow and Clyde
    • Contact: Maureen Travers
    • Principal Investigator: Pierpaolo Pellicori

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Diuretic cessation; Participants will be asked to withhold their diuretic therapy (loop diuretics and mineralocorticoid receptor antagonists) 48 hours prior to visit	Other: Diuretics; As per group descriptions
Other: Usual diuretic regimen; Participants will take their usual diuretic regimen prior to study visit. At least one week is required between cross-over visits	Other: Diuretics; As per group descriptions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	at baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	at 3 hours

Collaborators and Investigators

• Sponsor: NHS Greater Glasgow and Clyde

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2021
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: March 26, 2021
• First Submitted That Met QC Criteria: October 21, 2021
• First Posted (Actual): October 22, 2021

Study Record Updates

• Last Update Posted (Actual): October 22, 2021
• Last Update Submitted That Met QC Criteria: October 21, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure; Physiological Effects of Drugs; Natriuretic Agents; Diuretics
• Other Study ID Numbers: GN18CA427

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No