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

• Status: Completed
• Trial end date: 2020-02-20
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Adhish Agarwal
• Collaborator: University of Utah Center for Clinical and Translational Science
• Treatments: Furosemide

Criteria

Inclusion Criteria:

• History of chronic (> 6 months) heart failure with current New York Heart Association II-III symptoms

• Left ventricular ejection fraction > 50% on a clinically indicated echocardiogram obtained within last 12 months

• Clinical compensated heart failure

• On constant medical therapy for heart failure; without changes in heart failure medication regimen (including diuretics) for previous 14 days and not expected to change in the next 2 days

Exclusion Criteria:

• Unable to comply with protocol or procedures

• Uncontrolled severe hypertension: systolic blood pressure > 160 mmHg

• Significant renal impairment as defined by estimated glomerular filtration rate < 30ml/min/1.73m^2 determined by Chronic Kidney Disease - Epidemiology Collaboration equation

• Significant proteinuria (> 0.5 g protein/daily protein or equivalent)

• Body Mass Index > 40 kg/m^2

• Acute coronary syndrome within last 4 weeks

• Coronary revascularization procedures (percutaneous coronary intervention or cardiac artery bypass graft) or valve surgery within 30 days of screening

• Cardiac resynchronization therapy, with or without implantable cardioverter defibrillator within 90 days of screening

• Clinically relevant cardiac valvular disease

• Hypertrophic or restrictive cardiomyopathy, constrictive pericarditis, active myocarditis, active endocarditis, or complex congenital heart disease

• Cirrhosis of the liver

• History of known hydronephrosis

• History of adrenal insufficiency