search
Back to results

Quantifying Congestion by Ultrasound (QUEST-HF)

Primary Purpose

Heart Failure

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Diuretics
Sponsored by
NHS Greater Glasgow and Clyde
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Heart Failure

Eligibility Criteria

19 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • NHS Greater Glasgow and Clyde

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Diuretic cessation

Usual diuretic regimen

Arm Description

Participants will be asked to withhold their diuretic therapy (loop diuretics and mineralocorticoid receptor antagonists) 48 hours prior to visit

Participants will take their usual diuretic regimen prior to study visit. At least one week is required between cross-over visits

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
March 26, 2021
Last Updated
October 21, 2021
Sponsor
NHS Greater Glasgow and Clyde
search

1. Study Identification

Unique Protocol Identification Number
NCT05090137
Brief Title
Quantifying Congestion by Ultrasound
Acronym
QUEST-HF
Official Title
Quantifying Interstitial and Intravascular Fluid Accumulation by Ultrasound Following Temporary Suspension of Loop Diuretics in Patients With Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 2021 (Anticipated)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NHS Greater Glasgow and Clyde

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Diuretic cessation
Arm Type
Other
Arm Description
Participants will be asked to withhold their diuretic therapy (loop diuretics and mineralocorticoid receptor antagonists) 48 hours prior to visit
Arm Title
Usual diuretic regimen
Arm Type
Other
Arm Description
Participants will take their usual diuretic regimen prior to study visit. At least one week is required between cross-over visits
Intervention Type
Other
Intervention Name(s)
Diuretics
Intervention Description
As per group descriptions
Primary Outcome Measure Information:
Title
Differences in ultrasound markers or congestion following continuation or suspension of diuretics for 48 hours.
Description
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 Outcome Measure Information:
Title
The acute variation in interstitial and intravascular congestion on imaging tests following administration of diuretics.
Description
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
Title
The acute variation in biomarkers of congestion, inflammation and myocardial injury following administration of diuretics.
Description
The acute variation in biomarkers of congestion (NT-proBNP), inflammation (HsCRP) and myocardial injury (Troponin) following administration of diuretics.
Time Frame
at 3 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pierpaolo Pellicori, MD, FESC
Phone
+44 0141 330 4744
Email
pierpaolo.pellicori@glasgow.ac.uk
Facility Information:
Facility Name
NHS Greater Glasgow and Clyde
City
Glasgow
Country
United Kingdom
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maureen Travers
First Name & Middle Initial & Last Name & Degree
Pierpaolo Pellicori

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Quantifying Congestion by Ultrasound

We'll reach out to this number within 24 hrs