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Diuretics and Dopamine in Heart Failure With Preserved Ejection Fraction (ROPA-DOP)

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ClinicalTrials.gov Identifier: NCT01901809
Recruitment Status : Completed
First Posted : July 17, 2013
Results First Posted : May 17, 2018
Last Update Posted : August 16, 2018
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Tracking Information
First Submitted Date  ICMJE May 15, 2013
First Posted Date  ICMJE July 17, 2013
Results First Submitted Date  ICMJE April 18, 2018
Results First Posted Date  ICMJE May 17, 2018
Last Update Posted Date August 16, 2018
Actual Study Start Date  ICMJE August 2013
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 18, 2018)
  • Percent Change in Serum Creatinine at 72 Hours. [ Time Frame: 72 hours ]
    Percent change in serum creatinine from randomization to 72 hrs from treatment protocol initiation.
  • Percent Change in Serum Creatinine at 72 Hours - Continuous vs Intermittent Diuretic [ Time Frame: 72 hours ]
    Percent change in serum creatinine from randomization to 72 hrs from treatment protocol initiation by diuretic strategy
  • Percent Change in Serum Creatinine at 72 Hours - Dopamine vs No Dopamine [ Time Frame: 72 hours ]
    Percent change in serum creatinine from randomization to 72 hrs from treatment protocol initiation by dopamine strategy
Original Primary Outcome Measures  ICMJE
 (submitted: July 15, 2013)
Change in glomerular filtration rate at 72 hours [ Time Frame: 72 hours ]
Change in glomerular filtration rate (GFR, mL/min/1.73 m2) as calculated by the Modification of Diet in Renal Disease (MDRD) study formula from randomization to 72 hrs from treatment protocol initiation.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: July 15, 2013)
  • Change in incidence of acute kidney injury [ Time Frame: 72 hours ]
    Change in incidence of acute kidney injury (defined as rise in in-hospital serum creatinine of > 0.3 mg/dL and relative increase of > 25% of the serum creatinine) from randomization to 72 hrs.
  • Volume of diuresis measured in liters [ Time Frame: 72 hours ]
    Volume of diuresis measured in liters calculated as both cumulative volume of diuresis measured in liters and cumulative volume of diuresis measured in liters adjusted for BMI
  • Six minute walk distance [ Time Frame: Basline, 72 hours, and on the day of discharge, an expected average of 6 days. ]
    Change in distance during 6 minute walk test from admission to 72 hrs and on the day of discharge, an expected average of 6 days.
  • Global well-being assessment score [ Time Frame: Baseline, 72 hours, and and on the day of discharge, an expected average of 6 days ]
    Global well-being assessment score from admission to 72 hrs, and on the day of hospital discharge, an expected average of 6 days. To be assessed by a Visual Analog Scale (VAS).
  • Heart failure readmissions [ Time Frame: 30 day and 6 months ]
    24. 30 day and 6 month hospital readmission or ER visit for major adverse cardiovascular event, heart failure, renal failure, syncope, or arrhythmia. Readmission events will be adjudicated by a Clinical Event Committee consisting of 2-3 cardiologists not directly in contact with patients enrolled in the study.
  • Frailty index [ Time Frame: Baseline, 72 hours, and and on the day of discharge, an expected average of 6 days ]
    Change in frailty index from admission to 72 hrs, and on the day of hospital discharge, an expected average of 6 days. To be assessed by the Johns Hopkins Older Americans Independence Center Online Frailty Assessment Tool
  • Subjective dyspnea score [ Time Frame: Baseline, 72 hours, and on the day of discharge, an expected average of 6 days ]
    Subjective dyspnea score from admission to 72 hrs, and on the day of hospital discharge, an expected average of 6 days. To be assessed by a Visual Analog Scale (VAS).
  • Length of stay [ Time Frame: Length in days from admission to discharge from the hospital, an expected average of 6 days. ]
    Length of stay of hospitalization in days, an expected average of 6 days
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Diuretics and Dopamine in Heart Failure With Preserved Ejection Fraction
Official Title  ICMJE Randomized Evaluation of Heart Failure With Preserved Ejection Fraction (HFpEF) Patients With Acute Heart Failure and Dopamine (ROPA-DOP) Trial
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 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Heart Failure, Diastolic
Intervention  ICMJE
  • Drug: Furosemide
  • Drug: Dopamine
Study Arms  ICMJE
  • Active Comparator: Bolus furosemide and no dopamine

    If 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).

    Intervention: Drug: Furosemide
  • Active Comparator: Continuous infusion furosemide and no dopamine

    If 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).

    Intervention: Drug: Furosemide
  • Active Comparator: Bolus furosemide plus dopamine
    Intermittent furosemide diuretic therapy as outlined with the addition of dopamine at 3 µg/kg/min
    Interventions:
    • Drug: Furosemide
    • Drug: Dopamine
  • Active Comparator: Continuous furosemide plus dopamine
    Continuous furosemide diuretic therapy as outlined with the addition of dopamine at 3 µg/kg/min
    Interventions:
    • Drug: Furosemide
    • Drug: Dopamine
Publications * Sharma K, Vaishnav J, Kalathiya R, Hu JR, Miller J, Shah N, Hill T, Sharp M, Tsao A, Alexander KM, Gupta R, Montemayor K, Kovell L, Chasler JE, Lee YJ, Fine DM, Kass DA, Weiss RG, Thiemann DR, Ndumele CE, Schulman SP, Russell SD; Osler Medical Housestaff. Randomized Evaluation of Heart Failure With Preserved Ejection Fraction Patients With Acute Heart Failure and Dopamine: The ROPA-DOP Trial. JACC Heart Fail. 2018 Oct;6(10):859-870. doi: 10.1016/j.jchf.2018.04.008. Epub 2018 Aug 8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 18, 2018)
90
Original Estimated Enrollment  ICMJE
 (submitted: July 15, 2013)
120
Actual Study Completion Date  ICMJE May 2018
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01901809
Other Study ID Numbers  ICMJE NA 00083629
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Johns Hopkins University
Study Sponsor  ICMJE Johns Hopkins University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kavita Kavita, MD Johns Hopkins School of Medicine
PRS Account Johns Hopkins University
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP