Quantifying Congestion by Ultrasound

Heart Failure Clinical Trial

— QUEST-HF  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05090137
• Other study ID #: GN18CA427
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 2021
• Est. completion date: December 2022

Study information

• Verified date: October 2021
• Source: NHS Greater Glasgow and Clyde
• Contact: Pierpaolo Pellicori, MD, FESC
• Phone: +44 0141 330 4744
• Email: pierpaolo.pellicori[@]glasgow.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure

Intervention

Other:
• Diuretics
As per group descriptions

Locations

Country	Name	City	State
United Kingdom	NHS Greater Glasgow and Clyde	Glasgow

Sponsors (1)

Lead Sponsor	Collaborator
NHS Greater Glasgow and Clyde

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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