Early or Non-revoked in Hospital-day in Patients With Acute Heart Failure (HospDia)

Prospective and Randomized Comparative Analysis, Between Early or Non-revoked in Day Hospital in Patients With Acute Heart Failure

Heart failure is one of the major causes of hospitalization in Brazil and worldwide. Recent studies attempt to identify readmission and prognostic markers at the time of discharge from these patients. The reassessment and possibility of early therapeutic adjustment may be relevant in this context. Therefore, the prospective and randomized comparative use of early re-evaluation in Hospital-day versus non-intervention group has not yet been described. The objective of this study was to evaluate the impact on the re-hospitalization rate in 30 days of the early re-evaluation of the patients in the day-hospital versus the non-intervention group in heart failure. For this, a unicentric, randomized and prospective study will be performed, in which the Hospital-Day strategy is performed versus no intervention in a comparative manner. Hospital data (test results, medical outcomes, complications) of patients will be analyzed for safety and effectiveness. The hypothesis of this study is that the Hospital-Day strategy is superior to the non-intervention strategy and causes fewer rehospitalizations within 30 days.

Study Overview

• Status: Unknown
• Conditions: Heart Failure; Acute Heart Failure
• Intervention / Treatment: Other: medical evaluation

• Study Type: Interventional
• Enrollment (Anticipated): 720
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alexandre Soeiro, MD; Phone Number: +55112661-5299; Email: alexandre.soeiro@bol.com.br

Study Locations

• Brazil
  • São Paulo, Brazil, 05403000
    • Recruiting
    • Instituto do Coração - HMFMUSP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adult men and women aged> 18 years.
• Presence of decomposed CF III or IV of NYHA characterized by> 1 symptom (dyspnea, orthopnea or edema) + 1 clinical sign (rales, edema, ascites or pulmonary congestion on chest X-ray).
• LVEF <45% on transthoracic echocardiography.
• BNP> 400 pg / mL.
• Clinical condition of hospital discharge.
• Signed consent form.

Exclusion Criteria:

• Pregnancy
• Body mass index greater than 40 kg / m2.
• Chronic obstructive pulmonary disease.
• Acute coronary syndrome.
• Acute myocarditis.
• Valvular heart disease.
• Need to use vasoactive drug.
• Cirrhosis of the liver Child C.
• Chronic dialysis renal insufficiency or creatinine> 3.0 mg / dL.
• Indication of implantation device of artificial stimulation.
• Pulmonary thromboembolism.
• Neoplasm terminal.
• Sepsis or septic shock.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hospital Day; Patients in the Hospital-Day group will return for medical evaluation 7-14 days in the specific unit.	Other: medical evaluation; return of medical evaluation after discharge
Other: Outpatient clinic; The patients in control group will return for medical evaluation 30 days at the outpatient clinic.	Other: medical evaluation; return of medical evaluation after discharge

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of 30-days rehospitalization rate	30-days rehospitalization rate	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	30-days mortality rate	30 days

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Anticipated): October 1, 2020
• Study Completion (Anticipated): October 1, 2021

Study Registration Dates

• First Submitted: October 19, 2018
• First Submitted That Met QC Criteria: October 22, 2018
• First Posted (Actual): October 24, 2018

Study Record Updates

• Last Update Posted (Actual): October 24, 2018
• Last Update Submitted That Met QC Criteria: October 22, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: PSInCor-ICxHospDia

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No