Heart FailureQUEST-HFNCT05090137
Quantifying Congestion by Ultrasound
A study testing Diuretics in people with Heart Failure, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 19 to 100 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Diuretics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2021to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
NHS Greater Glasgow and Clyde
Glasgow
Maureen Travers
Pierpaolo Pellicori
About this study
Official title: 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.
- Conditions
- Heart Failure
- Being tested
- Diuretics
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiureticsOther
As per group descriptions
| Study group | Role | What they receive |
|---|---|---|
| Diuretic cessation | Other | Participants will be asked to withhold their diuretic therapy (loop diuretics and mineralocorticoid receptor antagonists) 48 hours prior to visit Receives: Other: Diuretics |
| Usual diuretic regimen | Other | Participants will take their usual diuretic regimen prior to study visit. At least one week is required between cross-over visits Receives: Other: Diuretics |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at baseline
Secondary outcomes (2)
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.
Measured: 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.
Measured: at 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2021
- Study startNov 2021 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05090137
- Sponsor's protocol ID
- GN18CA427
- Acronym
- QUEST-HF
- Status last verified
- Oct 2021
- First submitted
- 26 Mar 2021
- Last updated
- 22 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantifying Interstitial and Intravascular Fluid Accumulation by Ultrasound Following Temporary Suspension of Loop Diuretics in Patients With Heart Failure
- ClinicalTrials.gov ID
- NCT05090137
- Acronym / sponsor ID
- QUEST-HF / GN18CA427
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Study start
- Nov 2021 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 22 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diuretic cessation | Other | Other: DiureticsParticipants will be asked to withhold their diuretic therapy (loop diuretics and mineralocorticoid receptor antagonists) 48 hours prior to visit |
| Usual diuretic regimen | Other | Other: DiureticsParticipants will take their usual diuretic regimen prior to study visit. At least one week is required between cross-over visits |
Who may qualify
- Ages
- 19 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DiureticsAs per group descriptions | Other | Diuretic cessation, Usual diuretic regimen |
Primary outcome
Differences in ultrasound markers or congestion following continuation or suspension of diuretics for 48 hours.
Time frame: 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.
2 secondary outcomes
The acute variation in interstitial and intravascular 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.
Time frame: at 3 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diuretics in people with Heart Failure, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pierpaolo Pellicori, MD, FESC (+44 0141 330 4744, pierpaolo.pellicori@glasgow.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in ultrasound markers or congestion following continuation or suspension of diuretics for 48 hours. (time frame: at baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2021.