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

Heart Failure Clinical Trial

— HospDia  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03717636
• Other study ID #: PSInCor-ICxHospDia
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: October 1, 2021

Study information

• Verified date: October 2018
• Source: University of Sao Paulo General Hospital
• Contact: Alexandre Soeiro, MD
• Phone: +55112661-5299
• Email: alexandre.soeiro[@]bol.com.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 720
• Est. completion date: October 1, 2021
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Heart Failure
• Heart Failure

Intervention

Other:
• medical evaluation
return of medical evaluation after discharge

Locations

Country	Name	City	State
Brazil	Instituto do Coração - HMFMUSP	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of 30-days rehospitalization rate	30-days rehospitalization rate	30 days
Secondary	Mortality	30-days mortality rate	30 days