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

NCT ID: NCT03717636

Last Updated: 2018-10-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 720 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-01
• Study Completion Date: 2021-10-01

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.

Conditions

Heart Failure; Acute Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hospital Day

Patients in the Hospital-Day group will return for medical evaluation 7-14 days in the specific unit.

Group Type: EXPERIMENTAL

medical evaluation

Intervention Type: OTHER

return of medical evaluation after discharge

Outpatient clinic

The patients in control group will return for medical evaluation 30 days at the outpatient clinic.

Group Type: OTHER

medical evaluation

Intervention Type: OTHER

return of medical evaluation after discharge

Interventions

medical evaluation

return of medical evaluation after discharge

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mucio Tavares, MD

Role: PRINCIPAL_INVESTIGATOR

Unidade Clínica de Emergência

Locations

Instituto do Coração - HMFMUSP

São Paulo, , Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Alexandre Soeiro, MD

Role: CONTACT

alexandre.soeiro@bol.com.br

+55112661-5299

Facility Contacts

Alexandre Soeiro, MD

Role: primary

alexandre.soeiro@bol.com.br

5511-2661-5299

Other Identifiers

PSInCor-ICxHospDia

Identifier Type: -

Identifier Source: org_study_id