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NATriuretic Response to Expansion and dIUretics in huMans With Heart Failure

NCT04235062 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 229

Last updated 2022-04-18

No results posted yet for this study

Summary

NATRIUM-HF is a multicenter, non-randomized, pre-post intervention study designed to assess renal response to intravascular fluid expansion and diuretics after sacubitril/valsartan (Entresto®) in euvolemic heart failure patients with reduced ejection fraction. Approximately 230 eligible patients will attend one visit prior to and visits 2 and 3 months after starting Entresto®. At each visit, the patient's responses to extravascular fluid expansion with Ringer's solution and to a loop diuretic bolus will be measured. Biomarkers measured in blood and urine samples will include natriuretic peptides (NP) B-type NP (BNP) and N-terminal proBNP (NT-proBNP), NP fragments, neprilysin activity and concentration, and other biomarkers related to heart failure.

Conditions

Interventions

DRUG

Ringer's (8.6 g/L sodium chloride, 0.33 g/L calcium chloride, 0.3 g/L potassium chloride) Solution

A 2-hour of infusion of Ringer's (8.6 g/L sodium chloride, 0.33 g/L calcium chloride, 0.3 g/L potassium chloride) solution will be given following completion of the first 3-hour urine collection period: 0.5 liter infused over 10 min followed by 0.5 liter infused over 1 hour 50 minutes.

DRUG

Intravenous Bolus Furosemide

Following completion of the second 3-hour urine collection period and after the second set of blood and urine samples are obtained, 40 mg of furosemide will be given as an IV bolus.

Sponsors & Collaborators

  • Saint-Louis-Lariboisière University Hospitals

    collaborator UNKNOWN

  • Abbott

    collaborator INDUSTRY

  • Momentum Research, Inc.

    lead INDUSTRY

Principal Investigators

  • Alexandre Mebazaa, MD PhD FESC · Hôpitaux Universitaires Saint-Louis-Lariboisière

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-01
Primary Completion
2021-04-26
Completion
2021-04-26

Countries

  • Armenia
  • Bosnia and Herzegovina
  • Russia

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04235062 on ClinicalTrials.gov