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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01901809
First Posted: July 17, 2013
Last Update Posted: March 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Stuart D. Russell, Johns Hopkins University
  Purpose
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.

Condition Intervention Phase
Heart Failure, Diastolic Drug: Furosemide Drug: Dopamine Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Evaluation of HFpEF Patients With Acute Heart Failure and Dopamine (ROPA-DOP) Trial

Resource links provided by NLM:


Further study details as provided by Stuart D. Russell, Johns Hopkins University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 120
Study Start Date: August 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

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).

Drug: Furosemide
Active Comparator: Bolus furosemide plus dopamine
Intermittent furosemide diuretic therapy as outlined with the addition of dopamine at 3 µg/kg/min
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
Drug: Furosemide Drug: Dopamine

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01901809


Locations
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Stuart D Russell, MD Johns Hopkins School of Medicine
  More Information

Responsible Party: Stuart D. Russell, Chief of Heart Failure and Transplant, Associate Professor of Medicine, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01901809     History of Changes
Other Study ID Numbers: JHH HFpEF 1
First Submitted: May 15, 2013
First Posted: July 17, 2013
Last Update Posted: March 8, 2017
Last Verified: March 2017

Keywords provided by Stuart D. Russell, Johns Hopkins University:
Heart failure, diastolic
HFpEF
Diuretics
Dopamine

Additional relevant MeSH terms:
Heart Failure
Heart Failure, Diastolic
Heart Diseases
Cardiovascular Diseases
Furosemide
Diuretics
Dopamine
Dopamine Agents
Natriuretic Agents
Physiological Effects of Drugs
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiotonic Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Neurotransmitter Agents
Protective Agents