Quantifying Congestion by Ultrasound

NCT ID: NCT05090137

Last Updated: 2021-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-30

Study Completion Date

2022-12-31

Brief Summary

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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

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Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Diuretic cessation

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

Group Type OTHER

Diuretics

Intervention Type OTHER

As per group descriptions

Usual diuretic regimen

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

Group Type OTHER

Diuretics

Intervention Type OTHER

As per group descriptions

Interventions

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Diuretics

As per group descriptions

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NHS Greater Glasgow and Clyde

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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NHS Greater Glasgow and Clyde

Glasgow, , United Kingdom

Site Status

Countries

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United Kingdom

Central Contacts

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Pierpaolo Pellicori, MD, FESC

Role: CONTACT

+44 0141 330 4744

Facility Contacts

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Maureen Travers

Role: primary

Other Identifiers

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GN18CA427

Identifier Type: -

Identifier Source: org_study_id