Heart Failure, DiastolicPhase 4ROPA-DOPNCT01901809
Diuretics and Dopamine in Heart Failure With Preserved Ejection Fraction
A Phase 4 study testing Furosemide and Dopamine in people with Heart Failure, Diastolic, run by Johns Hopkins University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Diastolic
- What is being tested?
- Furosemide and Dopamine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to May 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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:
Show all 21Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Evaluation of Heart Failure With Preserved Ejection Fraction (HFpEF) Patients With Acute Heart Failure and Dopamine (ROPA-DOP) Trial
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.
- Conditions
- Heart Failure, Diastolic
- Being tested
- Furosemide, Dopamine
- Keywords
- Heart failure, diastolic, HFpEF, Diuretics, Dopamine
- Medical subject headings
- Heart Failure, Diastolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FurosemideDrug
DopamineDrug
| Study group | Role | What they receive |
|---|---|---|
| Bolus furosemide and no dopamine | Active comparator | 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). Receives: Drug: Furosemide |
| Continuous infusion furosemide and no dopamine | Active comparator | 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). Receives: Drug: Furosemide |
| Bolus furosemide plus dopamine | Active comparator | Intermittent furosemide diuretic therapy as outlined with the addition of dopamine at 3 µg/kg/min Receives: Drug: Furosemide; Drug: Dopamine |
| Continuous furosemide plus dopamine | Active comparator | Continuous furosemide diuretic therapy as outlined with the addition of dopamine at 3 µg/kg/min Receives: Drug: Furosemide; Drug: Dopamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Serum Creatinine at 72 Hours.
Percent change in serum creatinine from randomization to 72 hrs from treatment protocol initiation.
Measured: 72 hours
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
Measured: 72 hours
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
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2013 (estimated)
- Study startAug 2013
- Primary completionJun 2017
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Heart Failure, DiastolicStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kavita Kavita, MD, Principal investigator, Johns Hopkins School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01901809
- Sponsor's protocol ID
- NA 00083629
- Acronym
- ROPA-DOP
- Status last verified
- Jul 2018
- First submitted
- 15 May 2013
- Last updated
- 16 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Rasoul D, Zhang J, Farnell E, Tsangarides AA, Chong SC, Fernando R, Zhou C, Ihsan M, Ahmed S, Lwin TS, Bateman J, Hill RA, Lip GY, Sankaranarayanan R. Continuous infusion versus bolus injection of loop diuretics for acute heart failure. Cochrane Database Syst Rev. 2024 May 22;5(5):CD014811. doi: 10.1002/14651858.CD014811.pub2.
PubMed 38775253Sharma 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.
PubMed 30098962
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Evaluation of Heart Failure With Preserved Ejection Fraction (HFpEF) Patients With Acute Heart Failure and Dopamine (ROPA-DOP) Trial
- ClinicalTrials.gov ID
- NCT01901809
- Acronym / sponsor ID
- ROPA-DOP / NA 00083629
- Conditions
- Heart Failure, Diastolic
- Keywords
- Heart failure, diastolic, HFpEF, Diuretics, Dopamine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Aug 2013 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 17 Jul 2013 (estimated)
- Results
- Posted 17 May 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Bolus furosemide and no dopamine | Active comparator | Drug: FurosemideIf 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). |
| Continuous infusion furosemide and no dopamine | Active comparator | Drug: FurosemideIf 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). |
| Bolus furosemide plus dopamine | Active comparator | Drug: Furosemide, Drug: DopamineIntermittent furosemide diuretic therapy as outlined with the addition of dopamine at 3 µg/kg/min |
| Continuous furosemide plus dopamine | Active comparator | Drug: Furosemide, Drug: DopamineContinuous furosemide diuretic therapy as outlined with the addition of dopamine at 3 µg/kg/min |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Furosemide | Drug | Bolus furosemide and no dopamine, Bolus furosemide plus dopamine, Continuous furosemide plus dopamine, Continuous infusion furosemide and no dopamine |
| Dopamine | Drug | Bolus furosemide plus dopamine, Continuous furosemide plus dopamine |
Primary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38775253Rasoul D, Zhang J, Farnell E, Tsangarides AA, Chong SC, Fernando R, Zhou C, Ihsan M, Ahmed S, Lwin TS, Bateman J, Hill RA, Lip GY, Sankaranarayanan R. Continuous infusion versus bolus injection of loop diuretics for acute heart failure. Cochrane Database Syst Rev. 2024 May 22;5(5):CD014811. doi: 10.1002/14651858.CD014811.pub2.
- Derived from this study: PubMed 30098962Sharma 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kavita Kavita, MD principal investigator
Johns Hopkins School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Furosemide and Dopamine in people with Heart Failure, Diastolic, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 May 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change in Serum Creatinine at 72 Hours. (time frame: 72 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01901809, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2018.