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

University of Sao Paulo General Hospital

Status: Unknown

Conditions: Acute Heart Failure; Heart Failure

Treatments: Other: medical evaluation

Study type: Interventional

Funder types: Other

Identifiers

NCT03717636

PSInCor-ICxHospDia

Details and patient eligibility

About

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.

Enrollment: 720 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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720 participants in 2 patient groups

Hospital Day

Experimental group

Description:

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

Treatment:

Other: medical evaluation

Outpatient clinic

Other group

Description:

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

Treatment:

Other: medical evaluation