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Clinical Trials/NCT05090137
NCT05090137
Unknown
Not Applicable

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

NHS Greater Glasgow and Clyde1 site in 1 country20 target enrollmentNovember 2021
ConditionsHeart Failure

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heart Failure
Sponsor
NHS Greater Glasgow and Clyde
Enrollment
20
Locations
1
Primary Endpoint
Differences in ultrasound markers or congestion following continuation or suspension of diuretics for 48 hours.
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2021
End Date
December 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • 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 Sites (1)

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