Heart Failure, Diastolic | Diuretics and Dopamine in Heart Failure With Preserved Ejection Fraction
Heart Failure, Diastolic research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Heart Failure, Diastolic
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Bolus furosemide and no dopamineIf the patient is not on a prior diuretic dose, a standard dose of furosemide 40mg IV every 12 hrs, with total dose of 80 mg IV over 24 hrs will be initiated. If the patient is already on a prescribed diuretic dose, their outpatient dose will be doubled and administered as the equivalent IV dose every 12 hrs. (i.e if the prescribed dose is furosemide 80mg by mouth twice daily, the inpatient treatment dose will be furosemide 80mg IV twice daily).
Continuous infusion furosemide and no dopamineIf the patient is not on a prior diuretic dose, a standard dose of furosemide 80mg IV over 24 hrs, will be initiated. If the patient is already on a prescribed diuretic dose, their outpatient dose will be doubled and administered as the equivalent IV dose continuously over 24 hrs. . (i.e. if the prescribed dose is furosemide 80mg by mouth twice daily, the inpatient treatment dose would be furosemide 160mg IV to be administered continuously over 24 hrs).
Bolus furosemide plus dopamineIntermittent furosemide diuretic therapy as outlined with the addition of dopamine at 3 µg/kg/min
Continuous furosemide plus dopamineContinuous furosemide diuretic therapy as outlined with the addition of dopamine at 3 µg/kg/min
Active, not recruiting
Start Date: August 2013
Completed Date: December 2017
Phase: Phase 4
Primary Outcome: Change in glomerular filtration rate at 72 hours
Secondary Outcome: Change in incidence of acute kidney injury
Study sponsors, principal investigator, and references
Principal Investigator: Stuart D Russell, MD
Lead Sponsor: Johns Hopkins University