Heart FailureHospDiaNCT03717636
Early or Non-revoked in Hospital-day in Patients With Acute Heart Failure
A study testing medical evaluation in people with Heart Failure and Acute Heart Failure, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Acute Heart Failure
- What is being tested?
- medical evaluation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 720 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Oct 2018to 1 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Pregnancy
- Body mass index greater than 40 kg / m2.
- Chronic obstructive pulmonary disease.
- Acute coronary syndrome.
- Acute myocarditis.
- Valvular heart disease.
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Instituto do Coração - HMFMUSP
São Paulo, 05403000
Alexandre Soeiro, MD, 5511-2661-5299, alexandre.soeiro@bol.com.br
About this study
Official title: Prospective and Randomized Comparative Analysis, Between Early or Non-revoked in Day Hospital in Patients With Acute Heart Failure
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
- Being tested
- medical evaluation
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
medical evaluationOther
return of medical evaluation after discharge
| Study group | Role | What they receive |
|---|---|---|
| Hospital Day | Experimental | Patients in the Hospital-Day group will return for medical evaluation 7-14 days in the specific unit. Receives: Other: medical evaluation |
| Outpatient clinic | Other | The patients in control group will return for medical evaluation 30 days at the outpatient clinic. Receives: Other: medical evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of 30-days rehospitalization rate
30-days rehospitalization rate
Measured: 30 days
Secondary outcomes (1)
Mortality
30-days mortality rate
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2018
- Study start1 Oct 2018
- Primary completion1 Oct 2020 (estimated)
- Study completion1 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 720 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mucio Tavares, MD, Principal investigator, Unidade Clínica de Emergência
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03717636
- Sponsor's protocol ID
- PSInCor-ICxHospDia
- Acronym
- HospDia
- Status last verified
- Oct 2018
- First submitted
- 19 Oct 2018
- Last updated
- 24 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective and Randomized Comparative Analysis, Between Early or Non-revoked in Day Hospital in Patients With Acute Heart Failure
- ClinicalTrials.gov ID
- NCT03717636
- Acronym / sponsor ID
- HospDia / PSInCor-ICxHospDia
- Conditions
- Heart Failure, Acute Heart Failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 720 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 Oct 2020 (estimated)
- Study completion
- 1 Oct 2021 (estimated)
- First posted
- 24 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hospital Day | Experimental | Other: medical evaluationPatients in the Hospital-Day group will return for medical evaluation 7-14 days in the specific unit. |
| Outpatient clinic | Other | Other: medical evaluationThe patients in control group will return for medical evaluation 30 days at the outpatient clinic. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (13 listed)
- Pregnancy
- Body mass index greater than 40 kg / m2.
- Chronic obstructive pulmonary disease.
- Acute coronary syndrome.
- Acute myocarditis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| medical evaluationreturn of medical evaluation after discharge | Other | Hospital Day, Outpatient clinic |
Primary outcome
Comparison of 30-days rehospitalization rate
Time frame: 30 days
30-days rehospitalization rate
1 secondary outcome
Mortality
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mucio Tavares, MD principal investigator
Unidade Clínica de Emergência
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing medical evaluation in people with Heart Failure and Acute Heart Failure, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexandre Soeiro, MD (+55112661-5299, alexandre.soeiro@bol.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of 30-days rehospitalization rate (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2018.