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

NCT03717636 | Unknown

• 1 other identifier: PSInCor-ICxHospDia
• Study Type: interventional
• Target: 720
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Comparison of 30-days rehospitalization rate

  30-days rehospitalization rate

  30 days

Secondary Outcomes (1)

• Mortality

  30 days

Study Arms (2)

Hospital Day

EXPERIMENTAL

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

Other: medical evaluation

Outpatient clinic

OTHER

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

Other: medical evaluation

Interventions

medical evaluation OTHER

return of medical evaluation after discharge

Hospital Day; Outpatient clinic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Instituto do Coração - HMFMUSP

São Paulo, 05403000, Brazil

RECRUITING

MeSH Terms

Conditions

Heart Failure

Interventions

Independent Medical Evaluation

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation

Study Officials

• Mucio Tavares, MD

  Unidade Clínica de Emergência

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandre Soeiro, MD

CONTACT

+55112661-5299; alexandre.soeiro@bol.com.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2018
• First Posted: October 24, 2018
• Study Start: October 1, 2018
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2021
• Last Updated: October 24, 2018

Record last verified: 2018-10

Locations

BR (1)