Heart Failure Clinical Trial
Official title:
Development of Clinical Prediction Rules and Health Services Research in Patients With Heart Failure (Health Services Evaluation in Heart Failure-ESSIC)
Objectives: Objective of this project are to create several clinical prediction rules (CPR)
to stratify patients into different prognostic levels: on arrival at the emergency room, at
hospital discharge, in the evolution at 90 days, and up to 1 year; for clinical parameters
(mortality, complications, readmissions) and the evolution of the patient health related
quality of life. Additional objectives include the analysis of equity in access, continuity
of care after discharge, costs, psychosocial support received, and variability in clinical
decisions and in the results obtained from inclusion in the study after the visit to the
emergency room until 1 year of follow-up. Methods: Prospective observational cohort study
with a one year follow-up. Multicenter and coordinated study with 9 hospital in Spain. This
project will include around 1000 patients diagnosed of heart failure who come to emergency
services of these hospitals, whether discharge home or admitted to the hospital. Multiple
parameters (about the process of care, clinical outcomes, and quality of life), will be
retrieved in the emergency room visits, admission, discharge and up to one year follow up
after discharge. This project bases its work in the large number of variables to be collected
and would not be viable with few centers, so centers from other communities will collaborate
providing more cases.
Statistical analysis using multivariate logistic regression models or Cox or general linear
models or multilevel analysis will derive the CPR in a subsample of the original sample which
will be validated in another different subsample.
DESIGN: multicenter prospective observational cohort study with one year follow-up after
inclusion in the study.
SCOPE: Nine hospitals participating in this project: Hospital Universitario Basurto, Santa
Marina, Donostia, and Galdakao-Usansolo, Hospital de Antequera, Costa del Sol, Universitario
de Canarias, Universitario Parc Taulí y Bellvitge.
SUBJECTS: patients with known chronic heart failure (or de novo diagnosed in the emergency
department visit) attended in the emergency services of the participating hospitals
prospectively diagnosed with acute or decompensated heart failure and recruited during the
first year of the study, including patients admitted or given discharge in the hospital
emergency room. The first admission of each patient during the recruitment period will be
taken as a reference, and after this episode the follow-up will be carried out during a whole
year, collecting all the events that happen related to their illness.
Missing patients: In all patients who meet the selection criteria the investigators will
collect data on essential sociodemographic and clinical variables in order to be able to
compare the patients lost in the follow-up with the patients who finally participate in the
entire study.
Sample size calculation: Predictive model development studies establish that it is necessary
to have at least 10 events of the dependent variable of interest (in our case: mortality,
major complications, recurrence or re-admissions, separately) for each independent variable
included in the multivariate logistic regression model . Given that our intention is to
include in the multivariate model a limited but exhaustive number of variables (predictably,
no less than 10), the investigators estimate that it will be necessary to have at least 100
events of the dependent variable in the derivation sample (of 1000 patients ) to make sure
that the regression model converges properly. Data from our centers indicate that the number
of events of the dependent mortality variable would be> 15% of the patients admitted, with
the percentages expected from the other parameters with higher results. With all the
participating centers and 1 year of recruitment, the investigators hope to recruit around
2000 valid patients (50% for the derivation and 50% in the validation sample) sufficient to
meet the stated objectives.
Sample size: Based on data from the year 2012 of our centers for this pathology and according
to the expected exclusions (80% will meet the selection criteria with their acceptance to
participate in the study ) and losses (20% of losses in the follow-up of those that meet the
selection criteria), the recruitment of this number of patients is guaranteed for the
majority of the participating centers and, therefore, the response to this and other
hypotheses of the study.
Sampling: non-probabilistic sampling of convenience of consecutively recruited patients in
each of the participating centers for 12 months.
VARIABLES. Sources for the collection of information: it will be done through the medical
record (of emergencies, hospital admission or primary care), information systems of the
participating centers (medical/electronic records), hospital and primary care, and directly
from patients through a survey. Summary of the variables to be collected:
1. Socio-demographic data: age, sex, level of studies, place of residence, distance to the
hospital, family situation.
2. Antecedents: symptoms; time of evolution; risk factors and health habits; previous
pharmacological / non-pharmacological treatments, previous vaccines; comorbidities and
their respective treatments; previous income by HF.
3. Clinical data:
A.-Presentation in the emergency room: a.1.-symptoms; a.2.-signs. a.3.- Complementary
tests and their result: ECG, chest x-ray, BNP test, laboratory parameters; urine
analysis. a.4.- Pharmacological treatment of HF; Other treatments; Specific treatments
and associated comorbidities. a.5.- Destination at discharge.
B.-Patients discharge from the emergency room: data at discharge (medication, symptoms
and signs, laboratory data and complementary examinations, diagnosis, destination at
discharge, prescribed controls) C.-Patients hospital admitted. Evolution of: c.1.-
symptoms; c.2.-signs. c.3.- Complementary tests performed: ECG, echocardiography, .
c.4.- Use of other complementary tests. c.5.- Diagnosis of the HF and type.
c.6.-Pharmacological treatment of HF; Other treatments; c.7.- Interventional procedures.
c.8.- Need for more intensive treatment. c.9.-Specific treatments and associated
comorbidities.
D.-Outcomes: death; complications during admission; Intensive treatments; Other
reperfusion treatments; Other complications; days of stay.
E.-Data at hospital discharge of patients admitted: symptoms, signs, laboratory data at
discharge, diagnosis at discharge, prescribed treatment, care and established controls.
4. Alternatives to classic hospital admission: home hospitalization, palliative care,
medium-stay units-centers.
5.-Other health care / interventions. 6-Utilization of health services after the emergency
visit / discharge from hospitalization.
7-Availability and use of psycho-social support services. 8.- Other results in the follow-up
until the year: Evolution of symptoms, signs and basic analytics, the latter included in the
readmissions and the primary care databases.
9-Quality of life questionnaires: Minnesota Living with Heart Failure Questionnaire (MLWHFQ;
EuroQol-5D and Barthel Index) Questionnaires to pass in the first contact and in the 1st
year, moments in which transitional questions on evolution will be included of symptoms and
general condition.
10.-Clinical results to be measured during follow-up: death, re-admissions, complications,
visits to the emergency department and surgical interventions, both cardiological and other,
evolution of dyspnea.
DATA COLLECTION: the above parameters will be collected from the arrival of the patient to
the emergency room until discharge (from the emergency room or after hospital admission) with
the patient being followed until one year after the index visit, collecting information on
the care received in other services (hospitalization), at home, primary care, for social
services, at the hospital level, (including possible new readmissions) through the clinical
history (of emergencies, hospital admission or primary care) and information systems of the
participating centers (medical/electronic records) and evolution of the quality of life
(PROm) and symptoms, for which the same questionnaires will be passed on again at the
baseline time per year.
ETHICAL AND CONFIDENTIALITY ASPECTS. The project has been evaluated by the research
commissions of the participating centers and the Clinical Research Ethics Committee
accredited (CEIC autonomic of the Basque Country in this case) receiving their approval. The
laws on personal data management will be followed, ensuring that the processing of personal
data will be carried out in such a way that the information obtained can not be associated
with identified or identifiable persons (Organic Law 15/1999, 13-12, Protection of Data of
Character Personal).
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05654272 -
Development of CIRC Technologies
|
||
Recruiting |
NCT05196659 -
Collaborative Quality Improvement (C-QIP) Study
|
N/A | |
Recruiting |
NCT05650307 -
CV Imaging of Metabolic Interventions
|
||
Active, not recruiting |
NCT05896904 -
Clinical Comparison of Patients With Transthyretin Cardiac Amyloidosis and Patients With Heart Failure With Reduced Ejection Fraction
|
N/A | |
Completed |
NCT05077293 -
Building Electronic Tools To Enhance and Reinforce Cardiovascular Recommendations - Heart Failure
|
||
Recruiting |
NCT05631275 -
The Role of Bioimpedance Analysis in Patients With Chronic Heart Failure and Systolic Ventricular Dysfunction
|
||
Enrolling by invitation |
NCT05564572 -
Randomized Implementation of Routine Patient-Reported Health Status Assessment Among Heart Failure Patients in Stanford Cardiology
|
N/A | |
Enrolling by invitation |
NCT05009706 -
Self-care in Older Frail Persons With Heart Failure Intervention
|
N/A | |
Recruiting |
NCT04177199 -
What is the Workload Burden Associated With Using the Triage HF+ Care Pathway?
|
||
Terminated |
NCT03615469 -
Building Strength Through Rehabilitation for Heart Failure Patients (BISTRO-STUDY)
|
N/A | |
Recruiting |
NCT06340048 -
Epicardial Injection of hiPSC-CMs to Treat Severe Chronic Ischemic Heart Failure
|
Phase 1/Phase 2 | |
Recruiting |
NCT05679713 -
Next-generation, Integrative, and Personalized Risk Assessment to Prevent Recurrent Heart Failure Events: the ORACLE Study
|
||
Completed |
NCT04254328 -
The Effectiveness of Nintendo Wii Fit and Inspiratory Muscle Training in Older Patients With Heart Failure
|
N/A | |
Completed |
NCT03549169 -
Decision Making for the Management the Symptoms in Adults of Heart Failure
|
N/A | |
Recruiting |
NCT05572814 -
Transform: Teaching, Technology, and Teams
|
N/A | |
Enrolling by invitation |
NCT05538611 -
Effect Evaluation of Chain Quality Control Management on Patients With Heart Failure
|
||
Recruiting |
NCT04262830 -
Cancer Therapy Effects on the Heart
|
||
Completed |
NCT06026683 -
Conduction System Stimulation to Avoid Left Ventricle Dysfunction
|
N/A | |
Withdrawn |
NCT03091998 -
Subcu Administration of CD-NP in Heart Failure Patients With Left Ventricular Assist Device Support
|
Phase 1 | |
Recruiting |
NCT05564689 -
Absolute Coronary Flow in Patients With Heart Failure With Reduced Ejection Fraction and Left Bundle Branch Block With Cardiac Resynchronization Therapy
|