RAAS Optimization for Acute CHF Patients



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 75
Updated:2/14/2019
Start Date:February 8, 2019
End Date:January 30, 2022
Contact:Study Coordinator
Email:avnibhatt@ufl.edu
Phone:916 337-9303

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Renin Angiotensin Aldosterone Optimization in Acute Decompensated Heart Failure

Holding ACEI/ARBs during initial 72 hours of admission with acute decompensated heart failure
may help preserve renal function with a lesser decline in GFR. This treatment modification
will also allow the option of aggressive diuresis in volume overloaded CHF patients which
should result in a lesser decline of AKI, length of stay, readmission rates, and cost
associated with CHF treatment.

The investigators hypothesize that worsening renal function can be mitigated by withholding
ACEI/ARB during the initial phase of in-patient treatment with aggressive diuresis. This
hypothesis will be tested by randomly allocating 360 admitted patients with ADHF on two
treatment paths: 1) no ACEI/ARB administered for initial 72 hours of treatment during
aggressive diuresis versus 2) full dose ACEI/ARB administered concurrently with aggressive
diuresis in naïve patients/home dose, who are already on such therapy. The study team hopes
to find that holding ACEI/ARBs during the initial 72 hours of admission with acute
decompensated systolic heart failure will help preserve renal function, as demonstrated by a
lesser decline in GFR. In addition, this treatment would allow the option of aggressive
diuresis in volume overloaded CHF patients, resulting in a lesser decline of AKI, length of
stay, readmission rates, and costs associated with CHF treatment. By understanding the
complex interaction between holding ACEIs/ARBs and continued aggressive diuresis, the
investigators intend to develop optimal dosing strategies for acute, decompensated CHF
patients, further minimizing adverse events such as electrolyte issues and declining GFR/AKI.

Inclusion Criteria:

Patients are eligible for enrollment if within the previous 24 hours they were treated with
acute decompensated heart failure or diagnosed on the basis of the investigator's clinical
diagnosis of heart failure, which needs to be supported by at least 2 the following
criteria:

- Elevated concentration of B-type natriuretic peptide (BNP) or N-terminal pro-BNP.
(Elevated BNP" defined as >300 for sinus rhythm, >500 for patients will atrial
fibrillation and elevated pro BNP defined as >1000 for sinus rhythm, >1600 for atrial
fibrillation.)

- Pulmonary edema on physical examination.

- Radiologic pulmonary congestion or edema.

- History of Chronic Heart Failure. Anticipated need for IV loop diuretics for at least
48 hours

- Willingness to provide informed consent

Exclusion Criteria:

- Previously diagnosed end-stage renal disease; Serum Potassium >5.5 mmol/L

- Cardiogenic Shock within 48 hours, ST-segment elevation myocardial infarction, ongoing
ischemia.

- Need for renal replacement therapy through dialysis or ultrafiltration

- Myocardial infarction within 30 days of screening.

- Patients with systolic blood pressure of less than 90 mm Hg.

- Patients requiring Intravenous Vasodilators or inotropic agents (other than Digoxin)
for heart failure

- BNP less than 250 ng/ml and/or proBNP less than 1000 mg/ml

- Pregnant women, prisoners, and institutionalized individuals

- Severe stenotic valvular disease

- Complex congenital heart disease

- Need for mechanical hemodynamic support

- Sepsis

- Terminal illness (other than HF) with expected survival of less than one year

- Previous adverse reaction to the study drugs

- Use of IV iodinated radiocontrast material in last 72 hours or planned during
hospitalization

- Enrollment or planned enrollment in another randomized clinical trial during this
hospitalization

- Inability to comply with planned study procedures

- Primary admission diagnosis other than acute heart failure
We found this trial at
1
site
2033 Mowry Road
Gainesville, Florida 32610
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mi
from
Gainesville, FL
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