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Diuretics and Dopamine in Heart Failure With Preserved Ejection Fraction

Information source: Johns Hopkins University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Heart Failure, Diastolic

Intervention: Furosemide (Drug); Dopamine (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Johns Hopkins University

Official(s) and/or principal investigator(s):
Stuart D Russell, MD, Principal Investigator, Affiliation: Johns Hopkins School of Medicine

Overall contact:
Stuart D Russell, MD, Phone: 410-955-5708, Email: srusse14@jhmi.edu

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. We 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 GFR. Secondary endpoints for readmission, functional capacity, quality of life, and amount of diuresis will also be collected.

Clinical Details

Official title: Randomized Evaluation of HFpEF Patients With Acute Heart Failure and Dopamine (ROPA-DOP) Trial

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Change in glomerular filtration rate at 72 hours

Secondary outcome:

Change in incidence of acute kidney injury

Volume of diuresis measured in liters

Six minute walk distance

Global well-being assessment score

Heart failure readmissions

Frailty index

Subjective dyspnea score

Length of stay

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Admission to Johns Hopkins Hospital for acute decompensated heart failure. 2. Patient ≥18 years of age 3. Estimated GFR of > 15 milliliters/min/1. 73m2 determined by the MDRD equation 4. Willingness to provide informed consent 5. 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. 6. Negative pregnancy test in a female of child bearing potential 7. Willingness of primary attending physician for patient to participate. Exclusion Criteria: 1. Systolic BP <90 mmHg on admission 2. Hemoglobin (Hgb) < 8 g/dl 3. Known allergy or intolerance to furosemide or low dose dopamine. 4. Hemodynamically significant arrhythmias including ventricular tachycardia or defibrillator shock within 4 weeks 5. Acute coronary syndrome within 4 weeks 6. 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 7. Non-cardiac pulmonary edema 8. Clinical evidence of digoxin toxicity 9. Received IV vasoactive treatment or ultra-filtration therapy for heart failure since initial presentation 10. Anticipated need for IV vasoactive treatment or ultra-filtration for heart failure during this hospitalization 11. History of temporary or permanent renal replacement therapy or ultrafiltration 12. History of renal artery stenosis > 50% 13. Need for mechanical hemodynamic support 14. Sepsis 15. Terminal illness (other than HF) with expected survival of less than 1 year 16. Previous adverse reaction to the study drugs 17. Use of IV iodinated contrast material/dye in last 72 hours or planned during hospitalization 18. Enrollment or planned enrollment in another randomized clinical trial during this hospitalization 19. Inability to comply with planned study procedures 20. Pregnancy or nursing mothers

Locations and Contacts

Stuart D Russell, MD, Phone: 410-955-5708, Email: srusse14@jhmi.edu

Johns Hopkins Hospital, Baltimore, Maryland 21287, United States; Recruiting
Stuart D Russell, MD, Phone: 410-955-5708, Email: srusse14@jhmi.edu
Kavita Sharma, MD, Phone: 410-955-5708, Email: ksharma8@jhmi.edu
Stuart D Russell, MD, Principal Investigator
Kavita Sharma, MD, Sub-Investigator
Steven Schulman, MD, Sub-Investigator
David Thiemann, MD, Sub-Investigator
Robert Weiss, MD, Sub-Investigator
David Kass, MD, Sub-Investigator
Additional Information

Starting date: August 2013
Last updated: March 31, 2015

Page last updated: August 23, 2015

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