Status:
COMPLETED
Evaluation of Renal Sodium Excretion After Salt Loading in Heart Failure With Preserved Ejection Fraction
Lead Sponsor:
Adhish Agarwal
Collaborating Sponsors:
University of Utah Center for Clinical and Translational Science
Conditions:
Heart Failure With Preserved Ejection Fraction
Eligibility:
All Genders
21-80 years
Phase:
EARLY_PHASE1
Brief 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 onl...
Detailed Description
In patients with heart failure with reduced ejection fraction (HFrEF), poor renal perfusion and neuro-hormonal activation cause renal salt and water retention. In contrast to HFrEF, patients with HFpE...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 6 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 20 2020
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT03837470
Start Date
May 6 2019
End Date
February 20 2020
Last Update
April 19 2021
Active Locations (1)
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1
University of Utah
Salt Lake City, Utah, United States, 84132