NCT05090137

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable heart-failure

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2021

Completed
7 months until next milestone

First Posted

Study publicly available on registry

October 22, 2021

Completed
10 days until next milestone

Study Start

First participant enrolled

November 1, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

October 22, 2021

Status Verified

October 1, 2021

Enrollment Period

1.1 years

First QC Date

March 26, 2021

Last Update Submit

October 21, 2021

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • The acute variation in interstitial and intravascular 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.

    at 3 hours

Study Arms (2)

Diuretic cessation

OTHER

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

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

Other: Diuretics

Interventions

DiureticsOTHER

As per group descriptions

Diuretic cessationUsual diuretic regimen

Eligibility Criteria

Age19 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NHS Greater Glasgow and Clyde

Glasgow, United Kingdom

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Diuretics

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Natriuretic AgentsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and Uses

Central Study Contacts

Pierpaolo Pellicori, MD, FESC

CONTACT

+44 0141 330 4744pierpaolo.pellicori@glasgow.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2021

First Posted

October 22, 2021

Study Start

November 1, 2021

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

October 22, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)