Early or Non-revoked in Hospital-day in Patients With Acute Heart Failure (HospDia)
Primary Purpose
Heart Failure, Acute Heart Failure
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
medical evaluation
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure
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.
Sites / Locations
- Instituto do Coração - HMFMUSPRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Hospital Day
Outpatient clinic
Arm Description
Patients in the Hospital-Day group will return for medical evaluation 7-14 days in the specific unit.
The patients in control group will return for medical evaluation 30 days at the outpatient clinic.
Outcomes
Primary Outcome Measures
Comparison of 30-days rehospitalization rate
30-days rehospitalization rate
Secondary Outcome Measures
Mortality
30-days mortality rate
Full Information
NCT ID
NCT03717636
First Posted
October 19, 2018
Last Updated
October 22, 2018
Sponsor
University of Sao Paulo General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03717636
Brief Title
Early or Non-revoked in Hospital-day in Patients With Acute Heart Failure
Acronym
HospDia
Official Title
Prospective and Randomized Comparative Analysis, Between Early or Non-revoked in Day Hospital in Patients With Acute Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
October 1, 2020 (Anticipated)
Study Completion Date
October 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sao Paulo General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Acute Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
720 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hospital Day
Arm Type
Experimental
Arm Description
Patients in the Hospital-Day group will return for medical evaluation 7-14 days in the specific unit.
Arm Title
Outpatient clinic
Arm Type
Other
Arm Description
The patients in control group will return for medical evaluation 30 days at the outpatient clinic.
Intervention Type
Other
Intervention Name(s)
medical evaluation
Intervention Description
return of medical evaluation after discharge
Primary Outcome Measure Information:
Title
Comparison of 30-days rehospitalization rate
Description
30-days rehospitalization rate
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Mortality
Description
30-days mortality rate
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexandre Soeiro, MD
Phone
+55112661-5299
Email
alexandre.soeiro@bol.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mucio Tavares, MD
Organizational Affiliation
Unidade Clínica de Emergência
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto do Coração - HMFMUSP
City
São Paulo
ZIP/Postal Code
05403000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandre Soeiro, MD
Phone
5511-2661-5299
Email
alexandre.soeiro@bol.com.br
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Early or Non-revoked in Hospital-day in Patients With Acute Heart Failure
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