drugset / Trial / NCT01901809

Diuretics and Dopamine in Heart Failure With Preserved Ejection Fraction

NCT01901809

Phase 4 Completed 90 enrolled Johns Hopkins University
RandomizedFactorialSingle-blindTreatment

Summary

Heart Failure with preserved Ejection Fraction (HFPEF) accounts for 40-50% of all heart failure patients with a frequency of hospital admissions for acute decompensation and short and long term mortality similar to patients with heart failure with reduced ejection fraction (HFREF). Patients with HFPEF are often preload dependent and despite admission to the hospital for acute decompensated heart failure (ADHF), are typically difficult to diurese due to the development of acute kidney injury. No studies have been performed evaluating treatment strategies for these patients. The investigators hypothesize that changing the method of diuresis and/or the addition of low-dose dopamine for the treatment of ADHF in patients with HFPEF will reduce renal injury, resulting in a shorter length of stay, and decrease hospital readmissions over the ensuing year. This trial will randomize patients to either bolus or continuous infusion furosemide and then to either dopamine or no dopamine. The primary endpoint will be renal function at 72 hours as measured by change in Glomerular Filtration Rate (GFR). Secondary endpoints for readmission, functional capacity, quality of life, and amount of diuresis will also be collected.

Timeline

Start
2013-08
Primary completion
2017-06
Completion
2018-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Dopamine Small molecule 3 ug/kg
Comparator Furosemide Other / unclassified 40 mg Intravenous
Comparator Furosemide Other / unclassified 80 mg Intravenous
Comparator Furosemide Other / unclassified 160 mg Intravenous