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

Primary Purpose

Heart Failure, Diastolic

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Furosemide

Dopamine

About this trial

This is an interventional treatment trial for Heart Failure, Diastolic focused on measuring Heart failure, diastolic, HFpEF, Diuretics, Dopamine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Johns Hopkins Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Arm Label

Bolus furosemide and no dopamine

Continuous infusion furosemide and no dopamine

Bolus furosemide plus dopamine

Continuous furosemide plus dopamine

Arm Description

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).

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).

Intermittent furosemide diuretic therapy as outlined with the addition of dopamine at 3 µg/kg/min

Continuous furosemide diuretic therapy as outlined with the addition of dopamine at 3 µg/kg/min

Outcomes

Primary Outcome Measures

Percent Change in Serum Creatinine at 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

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

Percent change in serum creatinine from randomization to 72 hrs from treatment protocol initiation by dopamine strategy

Secondary Outcome Measures

Full Information

NCT ID

NCT01901809

First Posted

May 15, 2013

Last Updated

July 20, 2018

Sponsor

Johns Hopkins University

1. Study Identification

Unique Protocol Identification Number

NCT01901809

Brief Title

Diuretics and Dopamine in Heart Failure With Preserved Ejection Fraction

Acronym

ROPA-DOP

Official Title

Randomized Evaluation of Heart Failure With Preserved Ejection Fraction (HFpEF) Patients With Acute Heart Failure and Dopamine (ROPA-DOP) Trial

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Completed

Study Start Date

August 2013 (Actual)

Primary Completion Date

June 2017 (Actual)

Study Completion Date

May 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Johns Hopkins University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Failure, Diastolic

Keywords

Heart failure, diastolic, HFpEF, Diuretics, Dopamine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Factorial Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

90 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Bolus furosemide and no dopamine

Arm Type

Active Comparator

Arm Description

Arm Title

Continuous infusion furosemide and no dopamine

Arm Type

Active Comparator

Arm Description

Arm Title

Bolus furosemide plus dopamine

Arm Type

Active Comparator

Arm Description

Intermittent furosemide diuretic therapy as outlined with the addition of dopamine at 3 µg/kg/min

Arm Title

Continuous furosemide plus dopamine

Arm Type

Active Comparator

Arm Description

Continuous furosemide diuretic therapy as outlined with the addition of dopamine at 3 µg/kg/min

Intervention Type

Drug

Intervention Name(s)

Furosemide

Intervention Type

Drug

Intervention Name(s)

Dopamine

Primary Outcome Measure Information:

Title

Percent Change in Serum Creatinine at 72 Hours.

Description

Percent change in serum creatinine from randomization to 72 hrs from treatment protocol initiation.

Time Frame

72 hours

Title

Percent Change in Serum Creatinine at 72 Hours - Continuous vs Intermittent Diuretic

Description

Percent change in serum creatinine from randomization to 72 hrs from treatment protocol initiation by diuretic strategy

Time Frame

72 hours

Title

Percent Change in Serum Creatinine at 72 Hours - Dopamine vs No Dopamine

Description

Percent change in serum creatinine from randomization to 72 hrs from treatment protocol initiation by dopamine strategy

Time Frame

72 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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 <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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kavita Kavita, MD

Organizational Affiliation

Johns Hopkins School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Johns Hopkins Hospital

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21287

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

30098962

Citation

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.

Results Reference

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Diuretics and Dopamine in Heart Failure With Preserved Ejection Fraction

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