Gender Specific Registry in Subjects Hospitalized With Heart Failure in Santiago (GENESIS)

August 5, 2025 updated by: Fundacion de la Sociedad Chilena de Cardiologia y Cirugia Cardiovascular

Gender Specific Registry in Subjects Hospitalized With Heart Failure in Santiago( GENESIS Registry): Pilot Heart Failure Registry Looking for Sex Analysis

This is an observational registry, which main purpose is to assess sex-related differences in heart failure (HF) presentation, management, and prognosis in patients admitted to a hospital with a certain diagnosis of HF. The diagnosis will be based on European Society of Cardiology (ESC) definition of HF ( clinical syndrome characterized by symptoms and/or signs caused by a cardiac abnormality, that results in elevated intracardiac pressure and/or inadequate output at rest or exercise ). The sample will be obtained prospectively by recruitment of patients of two hospitals of Santiago de Chile.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

-Methods Study design and participants

Observational and prospective registry led by the Chilean Society of Cardiology and Cardiac Surgery Foundation (Fundación SOCHICAR), that will be held at hospitals of different communes in urban Santiago. This project will incorporate two hospitals in a period of one year.

The hospital selection will be based on the purpose of having the most clinical information of the patient regarding his/her cardiac condition. Both participating centers must have coronary units, cardiac surgery, and interventional cardiology. Also, both hospitals must have medical teams with expertise in cardiac imaging, and have access to a local laboratory that performs biomarkers (i.e. NT-terminal pro-brain natriuretic peptide (NTpro-BNP), usTroponin).

The registry consists of a descriptive cross-sectional survey. Thereby, this study is a one-time assessment, with no visit schedule.

Ethics consideration The registry must be approved by the Ethics committee of each clinical center, or in case of not having one, by the Metropolitan Region Ethics Committee respective of each area. Each patient must be informed about the study's rationale and his/ her potential willingness of participation. Written informed consent will be obtained from all participants before data collection.

Study population: approximately 500 patients hospitalized in the two recruiting centers during one year who comply with all the eligible criteria and without exclusion criteria.

-Data source Data will be obtained from the medical files, and will be collected prospectively by a center coordinator using a tablet electronic survey. The survey will be created using a Google form questionnaire, easy to fill in and register.

The confidentiality of the patient will be protect, using patients´ identification based on their initials (first name - first last name - second last name) plus an odd or even sequential number according to the belonging hospital (ie: Mary Jo Salas Gómez MSG1).

The registry will include: demographic, cardiovascular (CV) risk factors, medical history, comorbidities, blood biochemical parameters, diagnostic imaging determinants, treatment, and outcomes data.

The information about Patient Healthe Questionnaire (PHQ) 9 questionnaire will be answered confidentially by the patient in the tablet

  • Study assessment The registry consists of a descriptive cross-sectional survey. Thereby, this study is a one-time assessment, with no visit schedule
  • Study limitations The main study limitation will be the failure to recruit 500 patients in the one-year period.

With respect to data limitation, the investigators will be conditioned by the information available in the medical file, and the laboratory and imaging exams requested by the head and referral physicians.

STATISTICAL METHODS Sample size and statistical power; precision assessment The sample size was estimated considering the data reported in one of the largest trials that have addressed sex differences in heart failure (HF-Action Trial by Sex, Am Heart J. 2009 Oct; 158(40): S16-S23.) 20. This trial shows that the prevalence of Heart Failure of ischemic cause (one of the main objectives of our trial) was 59% in males and 32% in females.

The calculation of the sample size was carried out to find significant differences between the prevalence of heart failure from ischemic etiology in female patients consecutively hospitalized compared to male, based on Chi-square test for comparison of proportions, considering a significance of 95% and power of 90 %. Therefore,the investigators will included in our study approximately 500 patients knowing that to get a significance of 95 % and a power of 90% the investigators must recruit at least 156 patients (52 females and 104 males) considering 2:1 male-to-female proportion. In order to perform a stratified analysis, the investigators estimated that the lowest sample size for each center should be 78 patients.( with 2:1 male -to - female proportion)

-Statistical considerations

Data management:

The data completeness and accuracy will be addressed through out-of-range alerts and control of unreported data. The nurse coordinator will verify the completeness and accuracy of the information and send the respective queries on a daily basis.

Missing data will be addressed according to covariate. Given the observational data collection of the registry, few data could be missing. These data will be addressed according the kind of covariate. In general, a multiple imputation strategy will be performed.

All the data will be electronically registered in an Excel file. Privileges will be conferred according the role of the personnel on the study. The Principal Investigators will have access to all data.

-Statistical Analyses: All the important covariates will be recorded. Specifically, information on patients' characteristics, demographics, basal functional capacity, complete blood test analyses, EKG, echocardiography, and relevant clinical information will be registered at baseline according to the protocol of each center. For analyses purposes, the prevalence of HF phenotype (ie. with preserved, mildly and reduced ejection fraction), and etiology (ie. ischemic and non ischemic) will be considered as primary outcomes.

All the variables will be tested for normality using Shapiro-Wilk test. The investigatorswill compare the percentages of heart failure with preserved ejection fraction (HFpEF), with mildly reduced ejection fraction (HFmrEF) and reduced ejection fraction (HFrEF) phenotypes according to gender, using Chi-square test. Also, the investigators will compare the percentages of HF etiology (ie. Ischemic and non ischemic) according to gender, using Chi-square test. Moreover, T-test statistics will be used according the variable.

The demographic variables that will be incorporated are:

  • Age
  • Sex
  • Educational Level: years of education < 8, > 8 and/or < 12, >12 years
  • Married, single, divorced, widowed
  • Race and Ethnic origin
  • Insurance status
  • Family income: ≤ $ 326.000 pesos (basic income) or less U$ 500 $ 326.000 -$ 652.000 $ 652.000 - $ 1.000.000 $ 1.000.000 -$2.000.000 $ ≥ 2.000.000- <3.000.000 $ ≥ 3.000.000
  • Employed, non employed, retired

The medical history that will be asked are:

  • Anemia
  • Smoking
  • Diabetes
  • Obesity
  • Depression
  • Hyperlipidemia
  • Hypertension
  • Atrial fibrillation /atrial flutter
  • Ventricular arrhythmias
  • Coronary disease
  • Ischemic heart disease /Previous myocardial infarction (MI)
  • Chronic obstructive pulmonary disease (COPD) / asthma
  • Cerebrovascular disease: Ischemic Stroke /Haemorrhagic stroke / transient ischaemic attack (TIA)
  • Peripheral vascular disease
  • Renal insufficiency (MRDR: less 60 ml /min /m2)
  • Dialysis (peritoneo/ Hemodialysis)
  • Preeclampsia / Gestational Diabetes / Premature delivery
  • Premature or late menarche
  • Premature of late menopause
  • Hyperkalemia
  • Previous hospitalization
  • Malignancies
  • Autoimmune diseases ( i.e. Erythematosus Systemic Lupus, Rheumatoid Arthritis, Chron Disease, Vasculitis , etc)
  • Genetic and Metabolic Disease (i.e. Fabry Disease, Muscular Dystrophies)

HF Characteristics.

  • Preserved
  • Mildly Reduced
  • Reduced

HF cause: ischemic, non ischemic and hypertensive.

Decompensating HF clinical factors.

  • Medication and diet non-adherence
  • Atrial fibrillation /flutter
  • Arrhythmias (other than AF) including bradyarrhythmias
  • Infections
  • Acute renal failure
  • Acute coronary syndrome
  • Anemia
  • Pulmonary thromboembolism
  • Others: specified

Precipitating clinical factors.

  • Respiratory ( pneumonia and others)
  • Arrhythmias
  • Medication non-compliance
  • Diet non-compliance
  • Uncontrolled Hypertension
  • Renal Failure
  • Myocardial Ischemia (ACS)

Questionnaires:

  • Quality of life Kansas City Cardiomyopathy Questionnaire.
  • Depression: Patient Health Questionnaire 9 (PHQ-9(scale)
  • HFpEF approach: The new H2FPEF (Heavy, 2 or more Hypertensive drugs, atrial Fibrillation, Pulmonary hypertension [pulmonary artery systolic pressure > 35 mmHg], Elder age > 60 years, and elevated Filling pressures [E/e´>9] ) score in patients hospitalized with HFpEF
  • Frailty Score: The Frail Score

Laboratory Determinations:

  • Nt-pro BNP
  • Hemoglobin levels
  • White blood count
  • Creatinine
  • Blood urea nitrogen (BUN)
  • Plasma Electrolytes
  • Troponin US
  • Albumin
  • Lipid profile
  • Thyroid stimulating hormone (TSH)
  • Hemoglobin A 1 C (if appropriate)
  • Ferritin and Iron levels

Imaging Determinations

  1. Echocardiography:

    • Ejection Fraction
    • Left Atrial volume
    • Left ventricular dimensions ( Systolic, Diastolic) and /or volumes.
    • LV segmentary motility (septal, anterior, inferior, posterior, lateral): akinesia,hypokinesia, dyskinesia( Yes/No for each one),
    • Presence of left ventricule (LV) thrombus
    • Pulmonary systolic arterial pressure
    • Mitral E/e´ratio
    • Global Longitudinal Strain
    • Valvular Regurgitations
    • Valvular Stenosis
    • Tricuspide annular plane systolic excursion (TAPSE)

  2. Thoracic Radiography (RX)

    • Pulmonary congestion
    • Left Ventricular enlargement
    • Right Ventricular enlargement
    • Pleural effusion

  3. Magnetic cardiac resonance

    • Late Gadolinium enhancement
    • Left ventricular volumen and ejection fraction
    • Right ventricular volumen and ejection fraction
    • Infiltrative cardiomyopathy pattern
    • Constrictive pericarditis
    • Thrombus
    • Hypertropic cardiomyopathy

  4. Coronary angiogram

    • Coronary stenosis ≥ 50 %: one vessel, two vessels or three vessels
    • Coronary stenosis ≥ 70 %:
    • Coronary Occlusion
    • Ventriculography (Yes or No): ejection fraction and motility description.

Treatment

1- Pharmacological: names and daily doses

  • B -blockers (total daily dose): bisoprolol, metoprolol,carvedilol, nebivolol, others
  • Angiotensin converting enzyme (ACE) inhibitors (total daily dose): enalapril, ramipril, captopril, perindopril, lisinopril, others/ Angiotensin 2 Receptors blockers (total daily dose): losartan, valsartan, telmisartan, candesartan, Olmesartan, others
  • Angiotensin receptor/neprilysin inhibitor (ARNI) (total daily dose): Sacubitril / Valsartan
  • Mineralocorticoid antagonist receptors (total daily dose): spironolactone /eplerenone/finerenone
  • Sodium glucose cotransporter 2 (SGLT 2) Inhibitors (total daily dose): dapagliflozin, empagliflozin.
  • Diuretics (total daily dose): furosemide (Intravenous /oral) metolazone, hydrochlorothiazide,chlortalidone, indapamide, others
  • Vericiguat
  • Ivabradine
  • Digoxin
  • Calcium Channel Blockers: amlodipine, others
  • Nitrites: Intravenous nitroglycerine/ Isosorbide dinitrate / Isosorbide mononitrate
  • Other vasodilators: hydralazine
  • Statins: atorvastatin, rosuvastatin, simvastatin, others
  • Ezetimibe
  • Anti diabetic drugs: metformin, glibenclamide, glipizide, insulin, dipeptidyl peptidase 4 (DPP4) such as sitagliptin, saxagliptin, linagliptin, vildagliptin and glucagon like peptide 1 (GLP1) analogues such as semaglutide, liraglutide, dulaglutide.
  • Anticoagulants: vitamin K antagonists (VKA), direct oral anticoagulants (OACs): apixaban, rivaroxaban, dabigatran.
  • Platelet inhibitors: aspirin, clopidogrel, ticagrelor.
  • Intravenous Iron Therapy

  • Intravenous Inotropic therapy: dobutamine, milrinone, levosimendan.

    2. Non pharmacological

  • Cardiovascular Rehabilitation (Yes /No)
  • Devices: Pacemaker / Cardiac resynchronization therapy/ (ICD) implantable cardioverter-defibrillator.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Chile
    • Region Metropolitana
      • Santiago, Region Metropolitana, Chile, 7700034
        • Recruiting
        • Paola Varleta
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population must comply with the definition of Heart Failure according to 2021 European Society of Cardiology (ESC) Guidelines. A practical definition of HF will be shortness of breath and/or fatigue and /or ankle swelling, and/or jugular venous distention and /or rales at the lung examination, with an ejection fraction by echocardiography >= 40% ( HF with Reduced ejection fraction- HFrEF) and /or greater than 40% (41 to 49 % represents HF with midly reduced ejection fraction-HFmrEF and >= 50% Preserved Eyection Fraction-HFpEF); this last one associated with pro BNP > 125 pg/ml in sinusal rhythm.

Description

Inclusion criteria:

  • Patient with ≥ 18 years old
  • Signed informed consent
  • Admitted to the hospital with a :
  • 1) diagnosis of acute HF as the leading cause of admission, and in which a CV therapy is needed and prescribed (ie. diuretic, vasodilator, inotropic, device), or
  • 2) diagnosis of chronic HF is established during the patient hospitalization based on clinical, biochemical and/or imaging studies, and in which cardiovascular therapy is needed and prescribed (ie. diuretic, vasodilator, inotropic, device ) during the hospitalization.

Exclusion criteria:

  • The patient presents a Covid 19 acute infection and/ or severe acute respiratory syndrome (SARS) -CoV 2 pneumonia is confirmed
  • The patient presents a psychiatric decompensated disorder and/or a cognitive impairment which preclude assessment of this survey.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The prevalence of HF phenotype( preserved, mildly reduced or reduced) by sex
Time Frame: 12 months
The outcome measure will be the prevalence (% of the study population) according to the HF phenotype (preserved, mildly reduced or reduced). The working definition of HF phenotypes will be in accordance to 2021 ESC guidelines of HF, based on the followimg criteria: a. clinical (shortness of breath and/or fatigue and /or ankle swelling, and/or jugular venous distention and /or rales at the lung examination),b. echocardiography: measurement of ejection fraction by transthoracic echocardiogram: HF with Reduced ejection fraction- HFrEF-(< 40%), HF with midly reduced ejection fraction-HFmrEF- (≥ 40 to 49 %) and Preserved Ejection Fraction- HFpEF- (≥ 50%), this last one associated with NT pro BNP (≥ 125 pg/ml in sinus rhythm.
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Prevalence of HF etiologies (ischemic, non ischemic or hypertensive) by sex.
Time Frame: 12 months
The outcome measure will be the prevalence of HF etiology (ischemic, non ischemic, and hypertensive). With regard to ischemic etiology, the study definition will be based on a definite diagnosis of ischemic heart disease (epicardial coronary artery stenosis greater than 50%, and /or previous myocardial infarction, and/or previous revascularization (CABG or PCI) or a positive imaging stress test, such as echo, nuclear, or cardiac magnetic resonance (CMR) . Hypertensive cardiomyopathy will be defined for HF with reduced , mild reduced or preserved eyection fraction only if long standing hypertension (at least 20 years) , and with cardiac structural changes suitable with hypertensive etiology: presence of diastolic dysfunction, and /or LV hypertrophy.
12 months
To evaluate socioeconomic level in the study population (patients hospitalized with HF) by sex specific analysis.
Time Frame: 12 months
To evaluate socioeconomic level in this cohort. The outcome measure will be based on the household average family income per capita based on the Chilean National Socioeconomic Characterization (CASEN) Survey 2020 (low from ∼276 to 340 US dollars; middle: ∼345 to 438 US dollars, and high: ∼459 to 2763 US dollars). The low socioeconomic level represents the minimum wage per capita in Chile in the study period
12 months
To evaluate educational level in the study population ( patients hospitalized with HF) by sex specific analysis.
Time Frame: 12 months
To evaluate educational level in this cohort. The outcome measure will be based on the years of education.
12 months
To assess the prevalence of comorbidities associated with HF by sex-specific analysis
Time Frame: 12 months
The comorbidities that will be analysed wil be: diabetes ( having a medical diagnosis of diabetes withor without pharmacological treatment or having fastingglucose ≥126 mg/dL), elderly (≥ 60 years of age, chronic renal failure (CKD) 4 or 5 phase, anemia ( hemoglobin value of less than 13.5 gm/dl in a man or less than 12.0 gm/dl in a woman), obesity (≥ 30 mg /kg 2 and Chronic obstructive pulmonary disease (COPD) based on the 2023 Global Initiative for Chronic Obstructive Lung Disease report last definition, which defines COPD as "a heterogeneous lung condition characterized by chronic respiratory symptoms (dyspnea, cough, expectoration, exacerbations) due to abnormalities of the airways (bronchitis, bronchiolitis) and/or alveoli (emphysema) that cause persistent, often progressive, airflow obstruction."
12 months
To determine the main decompensating risk factors in HF patients by sex-specific analysis
Time Frame: 12 months
The prevalence of decompensating risk factors that wil be assessed will be: medication and diet non-adherence, atrial fibrillation, infections, acute renal failure and acute coronary syndromes
12 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
To determine the presence of depressive symptoms and depression in hospitalized HF patients by a pre-specified sex analysis.
Time Frame: 12 months
The outcome measure will be assessed with the Patient Health Questionnaire (PHQ)-9 , which is a validated questionnaire to measure depressive symptoms. Mild-to-moderate depressive symptoms (10 to 19 points) and major depression (≥ 20 points). The more points , the closer to the diagnosis of depression.
12 months
To determine if frailty prevalence is different in hospitalized HF patients by sex pre-specified analysis.
Time Frame: 12 months
The outcome measure will be evaluated by the Simplle FRAIL questionnaire, consisting of 5 questiones. 3 or greater = frailty; 1 or 2 = prefrail
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fundacion de la Sociedad Chilena de Cardiologia y Cirugia Cardiovascular

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Pontificia Universidad Catolica de Chile
Hospital Dipreca

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: PAOLA VARLETA, MD, Fundacion de la Sociedad Chilena de Cardiologia y Cirugia Cardiovascular
  • Principal Investigator: MONICA ACEVEDO, MD, Fundacion de la Sociedad Chilena de Cardiologia y Cirugia Cardiovascular

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

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Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 11, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 18, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 27, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 7, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 5, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FSoChiCar-HF01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Upon request

IPD Sharing Time Frame

Only available upon request to the principal investigators after the acceptance of the first publication of the study.

For two years

IPD Sharing Access Criteria

For international academic investigators belonging to: universities , university hospitals, public hospitals, cardiology societies , and cardiology foundations associated to cardiology colleges and associations.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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