Diuretics and Dopamine in Heart Failure With Preserved Ejection Fraction

Heart Failure, Diastolic Clinical Trial

— ROPA-DOP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01901809
• Other study ID #: NA 00083629
• Status: Completed
• Phase: Phase 4
• Start date: August 2013
• Est. completion date: May 2018

Study information

• Verified date: July 2018
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: May 2018
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Diastolic

Intervention

Drug:
• Furosemide

• Dopamine

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change in Serum Creatinine at 72 Hours.	Percent change in serum creatinine from randomization to 72 hrs from treatment protocol initiation.	72 hours
Primary	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	72 hours
Primary	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	72 hours