Skip to content

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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03717636
Acronym
HospDia
Enrollment
720
Registered
2018-10-24
Start date
2018-10-01
Completion date
2021-10-01
Last updated
2018-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure, Acute Heart Failure

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.

Interventions

return of medical evaluation after discharge

Sponsors

University of Sao Paulo General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Comparison of 30-days rehospitalization rate30 days30-days rehospitalization rate

Secondary

MeasureTime frameDescription
Mortality30 days30-days mortality rate

Countries

Brazil

Contacts

Primary ContactAlexandre Soeiro, MD
alexandre.soeiro@bol.com.br+55112661-5299

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026