Health Condition 1: I509- Heart failure, unspecified
Conditions
Interventions
Intervention1: Nil: Nil
Intervention2: Nil: Nil
Intervention3: Nil: Nil
Control Intervention1: Nil: Nil
Sponsors
Sun Pharmaceutical Industries Limited (SPIL)
Eligibility
Inclusion criteria
Inclusion criteria: Patients satisfying all the following criteria will be included in the study: Male or female patients aged greater than equal to 30 years at the time of screening. Presence or known case of at least one of the following risk factors associated with early or preclinical heart failure: Hypertension Diabetes Mellitus Ischemic Heart Disease (IHD) / Coronary Artery Disease(CAD) Chronic Kidney Disease (CKD) Atrial Fibrillation Chronic Obstructive Pulmonary Disease (COPD) Obesity / Obstructive Sleep Apnoea Cardiomyopathy Hyperthyroidism History of Oncotherapy (chemotherapy or radiotherapy) Structural Heart Disease (e.g., left ventricular hypertrophy, valvular abnormalities) Willing and able to provide informed consent and comply with study procedures.
Exclusion criteria
Exclusion criteria: Patients satisfying any of the following criteria will be excluded from the study: Confirmed diagnosis of heart failure (Stage C or D) as per 2022 AHA/ACC/HFSA classification, recorded at any time prior to the index date. Acute Coronary Syndrome (ACS) within 1 month prior to screening. Hospitalization or major surgical procedure within the past 1 month.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with heart failure based on the age stratified cut-off for NT-proBNP levels for diagnosis of Heart Failure (HF).Timepoint: Baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients with heart stress based on the age stratified cut-off for NT-proBNP levels.Timepoint: Baseline;Incidence of heart failure related composite outcomes over 3 months [Defined as occurrence of visit to Emergency Department (ED), hospitalization for heart failure (HHF) & all-cause mortality].Timepoint: 3 months;Evaluate management practice & drug utilization pattern in the study population.Timepoint: 3 months;Exploratory Endpoints: Proportion of patients with heart failure based on the various cut-offs [such as Gender, renal dysfunction(eGFR), atrial fibrillation or flutter including ventricular rate, body mass index (BMI) & other clinically relevant factors affecting NTproBNP values] for NT-proBNP levels for diagnosis of Heart Failure (HF).Timepoint: Baseline;Incidence of extended composite endpoint over 3 months (defined as occurrence of Urgent Outpatient Visits, visit to Emergency Department (ED), hospitalization for heart failure (HHF), Myocardial infarction, stroke & all-cause mortality).Timepoint: 3 months;To evaluate the association between baseline biomarker levels & the incidence of HF related composite outcomesTimepoint: 3 months | — |
Countries
India
Contacts
Public ContactMs Colette Pinto
Sun Pharma Laboratories Limited
Outcome results
None listed