N/A
N=194
Short Stay Unit vs Hospitalization in Acute Heart Failure
Acute Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT03302910 ↗Enrolled (actual)
194
Serious AEs
6.2%
Results posted
Nov 2024
Primary outcome: Primary: Days Alive and Out of Hospital — 26.9; 25.4 Days Alive and Out of Hospital
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Short Stay Unit (Other); Standard of Care (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Indiana University
- Primary completion
- Jul 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Days Alive and Out of Hospital |
26.9; 25.4 | — |
| SECONDARY Quality of Life as Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) |
51.3; 45.8 | — |
Summary
The majority of the over one million annual AHF hospitalizations originate from the emergency department. Admitting and re-admitting lower risk AHF patients who don't need prolonged hospitalization may increase their risk for poor outcomes and decrease their quality of life: Safe alternatives to hospitalization from the ED are needed. We propose a strategy-of-care, short stay unit management of AHF (i.e. less than 24 hours), will lead to improved outcomes for lower risk AHF patients.
Eligibility Criteria
Inclusion:
- ED physician clinical diagnosis of AHF;
- Planned admission for AHF
- Systolic blood pressure > 100mmHg, heart rate < 115bpm*
- Previous history of HF *Patients with atrial fibrillation but controlled HR are eligible
For Caregiver Burden assessments. The eligibility criteria for a caregiver: 1) person either self-identifies, or when asked identifies themselves, as the primary caregiver for the patient. If there are multiple caregivers, the person who self-identifies as providing the most care will be asked to provide verbal informed consent.
Exclusion:
- Transplanted organ of any kind or ventricular assist device patient;
- End stage renal disease, on dialysis, or eGFR < 20 mL/min;
- Acute coronary syndrome (e.g. EKG changes consistent with ischemia or troponin elevation secondary to ACS);
- Other acute co-morbid conditions (e.g. sepsis, altered mental status) that are unlikely to be treated within a SSU stay;
- Patients who require ventilatory support of any kind or intravenous vasodilators/vasopressor/inotropic support. Patients who receive a one-time dose of an intravenious vasodiolator, but are no longer on this medication, are eligible.
- Pregnant patients or any patient who has been pregnant in the last 3 months
- < 18 years of age
- Any patient who in the opinion of the clinician or investigator requires hospitalization or ICU level care or will require rehabilitation or skilled nursing after discharge from the ED or hospital
- Planned discharge from the emergency department
- Patients hospitalized within the last 30 days ONLY if the institution mandates these patients are observed. Otherwise these patients are eligible.
- De Novo (new Onset) AHF
Data sourced from ClinicalTrials.gov (NCT03302910). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.