An observational study in Heart Failure，Congestive, Cardiac Rehabilitation and Physical Exercise, sponsored by Hospital Israelita Albert Einstein. Completed at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-03-09.
Sponsored by Hospital Israelita Albert Einstein · Observational
Among 204 studies in Heart Failure with a site in Brazil — 37 open to participants now, 46 under way, 20 of them phase 3. Heart Failure · Brazil.
Among the 204 studies in Heart Failure with a site in Brazil, this one is the 15th largest by enrollment of the 19 observational ones that give a count, is one of 11 that started in 2015, is one of 19 observational ones, and was the 116th registered.
6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.
Browse Heart Failure studies →37 of the 204 studies in Heart Failure with a site in Brazil are open now. Recruiting first, the newest first:
AstraZeneca · Sites in Brazil, United States, Argentina and 29 more countries
Bayer · Sites in Brazil, United States, Argentina and 20 more countries
CAROLINA NIGRO DI LEONE · Sites in Brazil
Novo Nordisk A/S · Sites in Brazil, United States, Argentina and 24 more countries
Bayer · Sites in Brazil, United States, Argentina and 20 more countries
A study can be open while its sites in Brazil have not opened yet or have stopped. Only those recruiting at a site in Brazil →
Of the 968 Heart Failure studies recruiting now, 691 (71%) set no upper age limit and 89 (9%) stop at 75 or younger; 64 take children under 18; 96 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
204 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 5 · Phase 2 23 · Phase 3 65 · Phase 4 15
First in 1999; this study’s year is marked. 11 started in 2015.
This study's enrollment of 70 is below the median of 200 across 1,983 observational studies indexed under Heart Failure.
Median enrollment 90 across the 183 interventional studies, 200 across the 19 observational. Of the 102 that completed or were terminated, 36 (35%) have results posted.
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63 of 204 have an industry lead sponsor. The 10 most frequent:
Hospital Israelita Albert Einstein is the lead sponsor of 147 studies on the registry; 32 are open to participants now.
Hospital Israelita Albert Einstein has 1 study filed under Heart Failure — fewer than ten, so there is no comparison to draw.
8 of the studies in Heart Failure with a site in Brazil that are under way reach primary completion within a year, 4 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07489547Phase 3Hospital de Clinicas de Porto AlegreMedication Withdrawal in Stable HF With Improved LVEF | 2026-12 |
| NCT06307652Phase 3AstraZenecaStudy to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With Heart Failure and Impaired Kidney Function | 2027-04-16 |
| NCT06024746Phase 3Colorado Prevention CenterA Study to Determine the Efficacy and Safety of Finerenone and SGLT2i in Combination in Hospitalized Patients With Heart Failure (CONFIRMATION-HF) | 2027-11 |
| NCT06008197Phase 3Colorado Prevention CenterA Study to Determine the Efficacy and Safety of Finerenone on Morbidity and Mortality Among Hospitalized Heart Failure Patients | 2027-11 |
| NCT07217392Abbott Medical DevicesLeft Bundle Branch Area Pacing (LBBAP) PMCF Study | 2027-04-30 |
Among the 204 studies in Heart Failure with a site in Brazil, from their registry updates:
This tab as a report to print or save as PDF → With an account.
A prospective longitudinal and observational clinical study will be conducted with hospitalized heart failure patients.The main purpose is to know the level of physical activity of these patients after their discharge in relation to the orientation received during their hospitalization and identify the barriers perceived by these patients to participate in a cardiac rehabilitation program. The outcomes are available by telephone calls in 30 and 90 days after discharge.
Heart failure is a progression epidemic problem, parallel to population aging. The costs of this disease are estimates in 38 billion of dollars per year, many of those have a relationship to high number of hospitalizations and decompensated heart failure. Non-adherence to drug treatment and non-pharmacological measures as cardiac rehabilitation are the major causes of high number of mortality and hospitalizations by heart failure. Our objectives will be to identify in decompensated heart failure inpatients the level of physical activity that they done before hospitalization, the barriers for the non-use of cardiac rehabilitation and their disposition to changes of lifestyle. Correlation between level of physical activity and readmission in 30 and 90 days after hospital discharge will be done. To understand the profile of these patients and difficulties for to do physical exercise could help to make future actions with focus in to obtain high adherence to changes in lifestyle.
Protocol of heart failure patients will be maped since their hospitalizaztion, however, their approach to get in the study will be fulfilled when they had medical release in 72 hours.
Inclusion criteria Patients in the heart failure protocol of the cardiology program with medical release in the next 72 hours
Exclusion criteria
Cardiac Rehabilitation in Advanced Heart Failure Patients
Know the physical activity level in heart failure patients before hospitalization
- To know the physical activity level in heart failure patients before the hospitalization using one questionnaire: the International Physical Activity Questionnaires (IPAQ).
Time frame: Before hospitalization
Know cardiac rehabilitation barriers in heart failure patients
-To identify the cardiac rehabilitation barriers in heart failure patients using a likert scale CRBS (Cardiac Rehabilitation Barriers Scale) which assesses patients' perceptions regarding the personal (patient), professional (health professional) and institutional (system) barriers that affect participation and adherence to cardiac rehabilitation programs.
Time frame: At screening
Know disposition for changes in life habits
- To identify the disposition for changes in life habits related to physical activity using the Disposition Scale described for Prochaska Jo and Diclemente with the results: pre contemplation, contemplation, preparation and action.
Time frame: At screening
Know the change from baseline physical activity level to 30 days after discharge
To know the physical activity level in heart failure patients 30 days after discharge using one questionnaire: the International Physical Activity Questionnaires (IPAQ).
Time frame: 30 days
Know the change from baseline physical activity level to 90 days after discharge
To know the physical activity level in heart failure patients 90 days after discharge using one questionnaire: the International Physical Activity Questionnaires (IPAQ).
Time frame: 90 days
Adhesion of orientation
Verify the adhesion of the orientation given in the hospitalization about medications and daily weight measure
Time frame: 90 days
New hospitalizations 30 and 90 days after discharge
Verify if there were new hospitalizations and its reasons in this period
Time frame: 30 and 90 days
Correlate new hospitalization with physical activity and orientations
Correlate the new hospitalization in 30 and 90 days after discharge with the participation in physical activity program and orientation given in the hospital (medications and daily weight measure) in the statistical analysis
Time frame: 90 days
Measure anxiety and depression
Measure anxiety and depression through HADS (Hospital Anxiety and Depression Scale) which shows if it is impossible, possible or probable.
Time frame: At screening
Measure cognitive impairment
Measure if the patient presents cognitive impairment applying the MMSE (Mini-mental State Examination).
Time frame: At screening
Correlate anxiety and depression with cognitive impairment
Correlate anxiety and depression with cognitive impairment in the statistical analysis
Time frame: At screening
Plan to share: Yes — De-identified individual participant data for all primary and secondary outcome measures will be made available.
Supporting information: Informed consent form
Time frame: Data will be available within 6 months of study completion.
Access criteria: Data acess requests will be reviewed by and internal or external Independent Review Panel. Requestors will be required to sign a Data Acess Agreement.
Ran from Mar 2015 to primary completion in Nov 2018, 44 months.
Of 793 non-industry observational studies under Heart Failure, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 99. This study's 44 months is close to that.
Counting every sponsor, half of 975 studies reached it within 41 months; a quarter within 23 and three quarters within 89.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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