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IV Diuretics for Heart Failure
N/A
Recruiting
Led By Stephen Greene
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
≥18 years of age
Be older than 18 years old
Must not have
New diagnosis of heart failure
End-stage kidney disease requiring chronic dialysis therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing if IV diuretics can help improve heart failure symptoms when taken at home. #OUTPATIENT-WHF
Who is the study for?
This trial is for adults over 18 with worsening heart failure who need IV diuretics, as judged by their doctor. They must have completed a health survey and be able to consent. It's not for those with heart devices, severe kidney disease on dialysis, new heart failure diagnosis, pregnancy, high fever at screening or any condition affecting study compliance.
What is being tested?
The OUTPATIENT-WHF study tests if giving IV diuretics in an outpatient clinic can effectively treat worsening heart failure compared to the usual initial hospitalization strategy. Patients will either receive treatment in the clinic or be hospitalized.
What are the potential side effects?
While specific side effects are not listed here, generally IV diuretics can cause electrolyte imbalances, kidney issues or low blood pressure. The exact side effects will depend on individual patient conditions and responses.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been recently diagnosed with heart failure.
Select...
I am on long-term dialysis for end-stage kidney disease.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 90 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Health status as measured by EuroQOL-5 dimensions (EQ5D) utility index
Health status as measured by EuroQOL-5 dimensions (EQ5D) visual analog scale (VAS)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Initial outpatient management strategy, including outpatient IV diuretics in clinicExperimental Treatment1 Intervention
Group II: Initial hospitalization-based management strategyExperimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
Duke UniversityLead Sponsor
2,462 Previous Clinical Trials
2,968,850 Total Patients Enrolled
Stephen GreenePrincipal InvestigatorDuke University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I prefer a specific treatment location for my heart failure and refuse to be randomly assigned.I am 18 years old or older.I have been recently diagnosed with heart failure.You have a fever over 101.0 degrees Fahrenheit when you are checked before the study.I am on long-term dialysis for end-stage kidney disease.You have had a heart transplant or a specific type of heart pump in the past.You have completed the EuroQOL-5 survey.My doctor has a strong preference for treating my heart failure either at home or in the hospital, and does not agree to choose by random selection.I was treated with IV diuretics for heart failure at a Duke clinic.
Research Study Groups:
This trial has the following groups:- Group 1: Initial outpatient management strategy, including outpatient IV diuretics in clinic
- Group 2: Initial hospitalization-based management strategy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.