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

Not Applicable

• Conditions: Heart Failure; Acute Heart Failure
• Interventions: Other: medical evaluation

• Registration Number: NCT03717636
• Lead Sponsor: University of Sao Paulo General Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-10
• Study Start: 2018-10-01
• Study First Submitted: 2018-10-19
• Study First Submitted QC: 2018-10-22
• Last Update Submitted: 2018-10-22
• Study First Posted: 2018-10-24
• Last Update Posted: 2018-10-24
• Primary Completion: 2020-10-01
• Study Completion: 2021-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 720

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hospital Day	medical evaluation	Patients in the Hospital-Day group will return for medical evaluation 7-14 days in the specific unit.
Outpatient clinic	medical evaluation	The patients in control group will return for medical evaluation 30 days at the outpatient clinic.

Primary Outcome Measures

Name	Time	Method
Comparison of 30-days rehospitalization rate	30 days	30-days rehospitalization rate

Secondary Outcome Measures

Name	Time	Method
Mortality	30 days	30-days mortality rate

Trial Locations

Locations (1)

Instituto do Coração - HMFMUSP; 🇧🇷 São Paulo, Brazil