Short Stay Unit vs Hospitalization in Acute Heart Failure

NCT03302910 | Completed Results DMC

• 1 other identifier: R01HS025411
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 11

Brief 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.

Conditions

Acute Heart Failure

Keywords

Acute Heart Failure, Chronic Heart Failure, Heart Failure, Heart conditions, nitroglycerin

Outcome Measures

Primary Outcomes (1)

• Days Alive and Out of Hospital

  To demonstrate the effectiveness of a SSU AHF management strategy vs standard of care

  30 day outcome

Secondary Outcomes (1)

• Quality of Life as Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ)

  30 day outcome

Other Outcomes (1)

• All Cause Mortality and Re-hospitalization

  30 and 90 days from randomization

Study Arms (2)

Short Stay Unit

EXPERIMENTAL

Subjects are assigned to the short stay unit (SSU) for approximately 23 hours treatment and observation period. In the SSU, patients will receive usual care for AHF, which includes loop diuretics and nitroglycerin, as needed.

Other: Short Stay Unit

Standard of Care

ACTIVE COMPARATOR

Subjects are assigned to inpatient hospitalization. During hospitalization, patients will receive usual care for AHF, which includes loop diuretics and nitroglycerin, as needed.

Other: Standard of Care

Interventions

Short Stay Unit OTHER

Subjects will be treated for acute heart failure in the SSU and observed for improvement then, if appropriate, discharged. If not appropriate for discharge they will be admitted to inpatient.

Also known as: SSU

Short Stay Unit

Standard of Care OTHER

Subjects who come to the ER with acute heart failure who are randomized to inpatient stay.

Also known as: SOC

Standard of Care

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (11)

University of Alabama - Birmingham

Birmingham, Alabama, 35294, United States

Location

Indiana University

Indianapolis, Indiana, 46201, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Beaumont Health System

Royal Oak, Michigan, 48073, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Washington University

St Louis, Missouri, 63130, United States

Location

Wake Forest School of Medicine

Winston-Salem, North Carolina, 27157, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Allegheny Health Network

Pittsburgh, Pennsylvania, 15212, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Related Publications (1)

• Pang PS, Berger DA, Mahler SA, Li X, Pressler SJ, Lane KA, Bischof JJ, Char D, Diercks D, Jones AE, Hess EP, Levy P, Miller JB, Venkat A, Harrison NE, Collins SP. Short-Stay Units vs Routine Admission From the Emergency Department in Patients With Acute Heart Failure: The SSU-AHF Randomized Clinical Trial. JAMA Netw Open. 2024 Jan 2;7(1):e2350511. doi: 10.1001/jamanetworkopen.2023.50511.

  PMID: 38198141 DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Limitations and Caveats

The COVID 19 pandemic significantly impacted our enrollment. As a result, we changed our primary endpoint to KCCQ-12 and our main secondary to 30-day DAOOH.

Results Point of Contact

• Title: Peter S. Pang
• Organization: Indiana University School of Medicine

ppang@iu.edu

317-880-3900

Study Officials

• Peter S Pang, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 2, 2017
• First Posted: October 5, 2017
• Study Start: December 6, 2017
• Primary Completion: July 22, 2021
• Study Completion: July 22, 2021
• Last Updated: November 20, 2024
• Results First Posted: November 20, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (11)