Guided diuretic therapy for acute heart failure treatment
A Randomized Trial of Protocolized Diuretic Therapy Compared to Standard Care in Emergency Department Patients With Acute Heart Failure
This study tests if a new way of using diuretics based on urine sodium levels can help people with acute heart failure feel better and stay in the hospital for a shorter time compared to standard care.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 474 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Vanderbilt University Medical Center Academic / other |
| Locations | 2 sites (Nashville, Tennessee and 1 other locations) |
| Trial ID | NCT04481919 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the effectiveness of a protocolized diuretic therapy guided by urinary sodium levels compared to standard care for patients with acute heart failure in the emergency department. Participants will be randomly assigned to either the new treatment approach or usual care after an initial evaluation. The goal is to enhance diuretic efficiency, reduce hospital stays, and improve patient outcomes by using objective measures to guide treatment decisions. The study aims to determine if this innovative approach leads to better clinical outcomes over a 14-day period.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 diagnosed with acute heart failure in the emergency department who require diuretic therapy.
Not a fit: Patients with end-stage renal disease, acute coronary syndrome, or severe heart failure conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve treatment outcomes and reduce hospital readmissions for patients with acute heart failure.
How similar studies have performed: Previous studies have shown promising results with similar approaches, but this specific protocol is being tested for the first time in this setting.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \> 18 * Emergency Department diagnosis of Acute Heart Failure (AHF) * Any one of the following: i. Chest radiograph or lung ultrasound consistent with AHF ii. Jugular venous distension iii. Pulmonary rales on auscultation iv. Lower extremity edema v. S3 gallop * \> 10 pounds of volume overload physician estimate or historical dry weight * IV diuretic ordered or planned to be during first 24 hours of ED or inpatient stay Exclusion Criteria: * End Stage Renal Disease (ESRD) requiring dialysis * Need for immediate intubation * Acute Coronary Syndrome - presentation consistent with myocardial ischemia AND new ST-Segment elevation/depression * Temperature \> 100.5ºF * End Stage Heart Failure: transplant list or ventricular assist device * Concurrent use of ototoxic medications including intravenous aminoglycosides and cisplatin * Systolic Blood Pressure \< 90 mmHg at time of consent * LV outflow obstruction, severe uncorrected stenotic valvular disease or severe restrictive cardiomyopathy * Greater than 2 doses of IV diuretic administered at the time of screening from the time of the hospital presentation leading to this admission (outside hospital time is included) * Severe, uncorrected serum electrolyte abnormalities at the time of consent (serum potassium \<3.0 mEq/L, magnesium \<1.0 mEq/L or sodium \<125 or \>150 mEq/l) * Lack of informed consent
Where this trial is running
Nashville, Tennessee and 1 other locations
- VA Tennessee Valley Health Service — Nashville, Tennessee, United States (Recruiting)
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)
Study contacts
- Principal investigator: Sean P. Collins, MD — Vanderbilt University Medical Center
- Study coordinator: Sean P. Collins, MD
- Email: sean.collins@vumc.org
- Phone: 615-936-0253
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.