Status:
COMPLETED
Diuretics and Dopamine in Heart Failure With Preserved Ejection Fraction
Lead Sponsor:
Johns Hopkins University
Conditions:
Heart Failure, Diastolic
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 mortal...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2018
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT01901809
Start Date
August 1 2013
End Date
May 1 2018
Last Update
August 16 2018
Active Locations (1)
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1
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287