Clinical Trials Logo

Clinical Trial 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.

Clinical Trial Description

Nearly 85% of acute heart failure (AHF) patients who present to the emergency department (ED) with acute heart failure (AHF) are hospitalized. Once hospitalized, within 30 days post-discharge, 27% of patients are re-hospitalized or die. Attempts to improve outcomes with novel therapies have all failed. The evidence for existing AHF therapies are poor: No currently used AHF treatment is known to improve outcomes. ED treatment is largely the same today as 40 years ago. Hospitalizing patients who don't need it may contribute to adverse outcomes. Hospitalization is not benign; patients enter a vulnerable phase post-discharge, at increased risk for morbidity and mortality. Patients would prefer to be home, not hospitalized. Furthermore, hospitalization and re-hospitalization for AHF predominantly affects patients of lower socioeconomic status (SES). Avoiding hospitalization in patients who don't need it may improve outcomes and quality of life, while reducing costs.

Short stay unit (SSU: less than 24 hours) management of AHF is effective for lower risk patients. However, it's only been studied in small studies or retrospective analyses. In addition, some have considered the SSU 'cheating' for hospitals trying to avoid 30 day readmission penalties, since SSU or observation didn't count as an admission. However, this quality measure is now changing. A robust clinical effectiveness trial would demonstrate the effectiveness of this patient-centered strategy.

Using a multi-center, randomized controlled design, this clinical effectiveness trial will test whether Short Stay Unit AHF management for < 24 hours increases days-alive-and-out-of-hospital, Quality of Life assessment (QoL), caregiver burden, and costs compared to inpatient management. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT03302910
Study type Interventional
Source Indiana University
Contact Peter S Pang, MD
Phone 317-880-3900
Status Recruiting
Phase Phase 2/Phase 3
Start date December 6, 2017
Completion date June 30, 2021

See also
  Status Clinical Trial Phase
Terminated NCT02151383 - Pharmacokinetics & Safety of Serelaxin on Top of Standard of Care Therapy in Pediatric Patients With Acute Heart Failure Phase 2
Completed NCT02135835 - A Study to Evaluate the Efficacy and Safety of Shenfu Zhusheye in Patients With Acute Heart Failure Phase 4
Completed NCT02122640 - Evaluation of Acute Cardiogenic Dyspnoea With Thorax Echography and Pro-BNP in the Emergency Department N/A
Completed NCT01193998 - Impact of Validated Diagnostic Prediction Model of Acute Heart Failure in the Emergency Department N/A
Not yet recruiting NCT01211886 - Utility of Brain Natriuretic Peptide (BNP) in Patients With Type IV Cardio-renal Syndrome Admitted to the Intensive Care Unit (ICU) N/A
Active, not recruiting NCT00512759 - Goal-directed Afterload Reduction in Acute Congestive Cardiac Decompensation Study Phase 4
Recruiting NCT03157219 - Manipal Heart Failure Registry (MHFR) N/A
Enrolling by invitation NCT02258984 - Can the Venus 1000 Help Clinicians Treat Patients With Severe Sepsis or Acute Heart Failure? The CVP Trial N/A
Completed NCT02141607 - Evolution of Molecular Biomarkers in Acute Heart Failure Induced by Shock
Completed NCT01870778 - Efficacy, Safety and Tolerability of Serelaxin When Added to Standard Therapy in AHF Phase 3
Recruiting NCT03161158 - PURE-HF: Peripheral Ultrafiltration for the RElief From Congestion in Heart Failure N/A
Not yet recruiting NCT03234647 - First In Human Study of the Doraya Catheter for the Treatment of AHF Patients N/A
Recruiting NCT03110042 - HILO-HF Registry: High Versus Low SpO2 Oxygen Therapy in Patients With Acute Heart Failure N/A
Completed NCT02350114 - An Observational Study of the Functional Capacity of Heart Failure N/A
Recruiting NCT01704131 - Levosimendan Pharmacokinetics in Children N/A
Completed NCT00561483 - Sequential Cystatin C Levels and Renal Impairment in Acute Heart Failure N/A
Withdrawn NCT02299726 - Early Aldosterone Blockade in Acute Heart Failure: An Exploratory Safety Study Phase 2
Completed NCT01834833 - Consultation at 8 Days to Reduce Hospitalisations in Heart Failure Patient N/A
Completed NCT01614860 - Identification of Patient Phenotypes Associated With Elevated Aldosterone Levels N/A
Completed NCT01619540 - Valsalva Manœuvre in the Diagnosis of Left Ventricular Failure in Chronic Obstructive Pulmonary Disease Exacerbation N/A