- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01901809
Diuretics and Dopamine in Heart Failure With Preserved Ejection Fraction (ROPA-DOP)
Randomized Evaluation of Heart Failure With Preserved Ejection Fraction (HFpEF) Patients With Acute Heart Failure and Dopamine (ROPA-DOP) Trial
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21287
- Johns Hopkins Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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). |
|
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). |
|
Active Comparator: Bolus furosemide plus dopamine
Intermittent furosemide diuretic therapy as outlined with the addition of dopamine at 3 µg/kg/min
|
|
Active Comparator: Continuous furosemide plus dopamine
Continuous furosemide diuretic therapy as outlined with the addition of dopamine at 3 µg/kg/min
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
72 hours
|
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
|
72 hours
|
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
|
72 hours
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kavita Kavita, MD, Johns Hopkins School of Medicine
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Heart Diseases
- Cardiovascular Diseases
- Heart Failure
- Heart Failure, Diastolic
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Protective Agents
- Natriuretic Agents
- Cardiotonic Agents
- Membrane Transport Modulators
- Dopamine Agents
- Diuretics
- Sympathomimetics
- Sodium Potassium Chloride Symporter Inhibitors
- Furosemide
- Dopamine
Other Study ID Numbers
- NA 00083629
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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