Diuretics and Dopamine in Heart Failure With Preserved Ejection Fraction



Status:Completed
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:8/18/2018
Start Date:August 2013
End Date:May 2018

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Randomized Evaluation of Heart Failure With Preserved Ejection Fraction (HFpEF) Patients With Acute Heart Failure and Dopamine (ROPA-DOP) Trial

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.


Inclusion Criteria:

- Admission to Johns Hopkins Hospital for acute decompensated heart failure.

- Patient ≥18 years of age

- Estimated GFR of > 15 milliliters/min/1.73m2 determined by the Modification of Diet in
Renal Disease (MDRD) equation

- Willingness to provide informed consent

- Known ejection fraction by noninvasive testing of > 50% within 12 months of admission
to the hospital with no interval myocardial infarction since inclusion transthoracic
echo, by history, or by ECG.

- Negative pregnancy test in a female of child bearing potential

- Willingness of primary attending physician for patient to participate.

Exclusion Criteria:

- Systolic BP <90 mmHg on admission

- Hemoglobin (Hgb) < 8 g/dl

- Known allergy or intolerance to furosemide or low dose dopamine.

- Hemodynamically significant arrhythmias including ventricular tachycardia or
defibrillator shock within 4 weeks

- Acute coronary syndrome within 4 weeks

- Cardiac diagnoses in addition to or other than HFpEF:

i. Active myocarditis ii. Hypertrophic obstructive cardiomyopathy iii. Severe valvular
disease iv. Restrictive or constrictive cardiomyopathy, including known amyloidosis,
sarcoidosis, hemachromatosis v. Complex congenital heart disease vi. Constrictive
pericarditis vii. Severe pulmonary hypertension (RVSP ≥ 60), not secondary to HFpEF

- Non-cardiac pulmonary edema

- Clinical evidence of digoxin toxicity

- Received IV vasoactive treatment or ultra-filtration therapy for heart failure since
initial presentation

- Anticipated need for IV vasoactive treatment or ultra-filtration for heart failure
during this hospitalization

- History of temporary or permanent renal replacement therapy or ultrafiltration

- History of renal artery stenosis > 50%

- Need for mechanical hemodynamic support

- Sepsis

- Terminal illness (other than HF) with expected survival of less than 1 year

- Previous adverse reaction to the study drugs

- Use of IV iodinated contrast material/dye 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

- Pregnancy or nursing mothers
We found this trial at
1
site
1800 Orleans St.
Baltimore, Maryland 21287
410-955-5000
Principal Investigator: Stuart D Russell, MD
Phone: 410-955-5708
Johns Hopkins Hospital Patients are the focus of everything we do at The Johns Hopkins...
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Baltimore, MD
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