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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03717636
Recruitment Status : Recruiting
First Posted : October 24, 2018
Last Update Posted : October 24, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Heart Failure Acute Heart Failure Other: medical evaluation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 720 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective and Randomized Comparative Analysis, Between Early or Non-revoked in Day Hospital in Patients With Acute Heart Failure
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : October 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Hospital Day
Patients in the Hospital-Day group will return for medical evaluation 7-14 days in the specific unit.
Other: medical evaluation
return of medical evaluation after discharge

Outpatient clinic
The patients in control group will return for medical evaluation 30 days at the outpatient clinic.
Other: medical evaluation
return of medical evaluation after discharge




Primary Outcome Measures :
  1. Comparison of 30-days rehospitalization rate [ Time Frame: 30 days ]
    30-days rehospitalization rate


Secondary Outcome Measures :
  1. Mortality [ Time Frame: 30 days ]
    30-days mortality rate



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03717636


Contacts
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Contact: Alexandre Soeiro, MD +55112661-5299 alexandre.soeiro@bol.com.br

Locations
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Brazil
Instituto do Coração - HMFMUSP Recruiting
São Paulo, Brazil, 05403000
Contact: Alexandre Soeiro, MD    5511-2661-5299    alexandre.soeiro@bol.com.br   
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
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Principal Investigator: Mucio Tavares, MD Unidade Clínica de Emergência

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Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT03717636    
Other Study ID Numbers: PSInCor-ICxHospDia
First Posted: October 24, 2018    Key Record Dates
Last Update Posted: October 24, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases