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Oral Sodium for Acute Heart Failure (OSPREY-AHF Trial)
N/A
Waitlist Available
Led By Robert A Montgomery, MD
Research Sponsored by The Cleveland Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥ 18 years old
Admitted to cardiology floor (non-ICU) with primary diagnosis of decompensated heart failure
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 96 hours
Awards & highlights
OSPREY-AHF Trial Summary
This trial will compare the effects of adding oral salt to IV diuretics vs. a placebo in people hospitalized for acute heart failure. The hypothesis is that the salt will help the diuretics work better, as measured by weight loss and kidney function.
Who is the study for?
This trial is for adults over 18 with acute decompensated heart failure hospitalized on a cardiology floor, not in ICU. They must have high levels of NT-proBNP and be starting high-dose IV diuretics. Exclusions include very high blood pressure, short hospital stay, certain medications or conditions affecting water balance or sodium levels, severe kidney dysfunction, and recent or upcoming contrast imaging.Check my eligibility
What is being tested?
The study tests if taking oral sodium chloride along with IV diuretics improves weight loss and kidney function in patients with acute heart failure compared to a placebo. It's a controlled trial where participants are randomly assigned to either the salt tablets or dummy pills without knowing which one they're getting.See study design
What are the potential side effects?
Potential side effects may include increased blood pressure due to extra sodium intake, fluid retention leading to swelling in limbs or lungs (pulmonary edema), potential worsening of heart failure symptoms, and possible negative impacts on kidney function.
OSPREY-AHF Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I am admitted to a cardiology unit with worsening heart failure.
Select...
I am starting a high-dose water pill infusion.
OSPREY-AHF Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 96 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 96 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Creatinine
Change in Weight
OSPREY-AHF Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Oral Sodium ChlorideActive Control1 Intervention
Subject will be given 2 grams of oral sodium chloride three times daily with meals for approximately 4 days
Group II: PlaceboPlacebo Group1 Intervention
Subject will be given a placebo orally three times daily with meals for approximately 4 days
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Who is running the clinical trial?
The Cleveland ClinicLead Sponsor
1,026 Previous Clinical Trials
1,366,009 Total Patients Enrolled
Robert A Montgomery, MDPrincipal InvestigatorThe Cleveland Clinic
W. H. Wilson Tang, MDPrincipal InvestigatorThe Cleveland Clinic
7 Previous Clinical Trials
1,874 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I cannot swallow pills or tolerate eating solid foods.Your NT-proBNP level is higher than 1000 ng/L.I have not used iodinated contrast material in the last 3 days.Your blood sodium level is below 120 or above 145.I have a condition like Crohn's disease that affects how my body absorbs nutrients.I am not using any IV drugs to help my heart pump or control my blood pressure.I am on dialysis.I have been diagnosed with diabetes insipidus.I am admitted to a cardiology unit with worsening heart failure.I am starting a high-dose water pill infusion.I am taking medication that blocks vasopressin.I am currently taking sodium chloride tablets.My kidney function is severely reduced.Your average blood pressure has been very high over the past day.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Oral Sodium Chloride
Awards:
This trial has 0 awards, including: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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any empty positions in this trial for new patients?
"No, this study is not currently looking for participants. Although, this was updated as recently as October 1st, 2022, the initial posting was on May 20th, 2020. There are other 737 trials that patients can participate in."
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