CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 14 enrolled
Drug / intervention
0.9% Sodium Chloride +1 moredrug
Likely dose
Furosemide 40 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03837470
NCT03837470Early Ph 1Completed

Evaluation of Renal Sodium Excretion After Salt Loading in Heart Failure With Preserved Ejection Fraction

Adhish Agarwal·interventional·Posted Feb 12, 2019·Updated Apr 19, 2021

In Brief

A Early Phase 1 clinical trial evaluating 0.9% Sodium Chloride and Furosemide 40 mg for Heart Failure With Preserved Ejection Fraction. Completed, enrolled 14 participants across 1 site.

Detailed Summary

Heart failure (HF) affects 2-3% of the population, and is characterized by impaired sodium balance which results in fluid overload. Ejection fraction, a measure of systolic function, is reduced in only about half of all HF patients. Incidence of heart failure with preserved ejection fraction (HFpEF) has increased in the last 20 years making it a growing public health problem. Currently, most patients admitted to the hospital with heart failure have preserved rather than reduced ejection fractions. However, to date it remains unknown why patients with HFpEF retain salt and water. The hypothesis is that patients with clinical HFpEF have an impaired renal response to salt loading, intravascular expansion and diuretics. Characterization of the salt and water excretory renal response to intravascular salt, fluid and diuretic load in patients with HFpEF will provide insight into the pathophysiology of HFpEF, and may help in the development of novel strategies to target renal sodium handling in patients with HFpEF. This characterization is the primary objective of this pilot project.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Early Ph 1CompletedFinished
20192020202120222023202420252026
First PostedFeb 12, 2019
Enrollment StartMay 6, 2019
Primary CompletionFeb 20, 2020
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 7.4 years ago

Interventions

0.9% Sodium Chloridedrug

Intravenous infusion of 0.25ml/kg/min of 0.9% sodium chloride intravenously for a total of 60 minutes

Furosemide 40 mgdrug

Bolus intravenous injection of 40 mg furosemide