Phase 4
N=90
Diuretics and Dopamine in Heart Failure With Preserved Ejection Fraction
Heart Failure, Diastolic
Bottom Line
View on ClinicalTrials.gov: NCT01901809 ↗Enrolled (actual)
90
Serious AEs
0.0%
Results posted
May 2018
Primary outcome: Primary: Percent Change in Serum Creatinine at 72 Hours. — 4; 11; 5; 20 percent change in serum creatinine
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Furosemide (Drug); Dopamine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins University
- Primary completion
- Jun 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Serum Creatinine at 72 Hours. |
4; 11; 5; 20 | — |
| PRIMARY Percent Change in Serum Creatinine at 72 Hours - Continuous vs Intermittent Diuretic |
4.6; 16 | 0.018 sig |
| PRIMARY Percent Change in Serum Creatinine at 72 Hours - Dopamine vs No Dopamine |
8.0; 12.8 | 0.33 |
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. 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.
Eligibility Criteria
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 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
Data sourced from ClinicalTrials.gov (NCT01901809). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.