Heart Failure IDentification in a High Risk Cardiovascular OutpatiEnt Population (HIDE)
Heart Failure IDentification in a High Risk Cardiovascular OutpatiEnt Population (HIDE)
ClinicalTrials.gov Identifier: NCT04143919
Novartis Reference Number: CLCZ696DGT01
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.
Study Description
This is a pilot, multicenter, real-world, single-visit, low risk, phase IV interventional study to efficiently identify new cases of heart failure (HF) Stage C in subjects who are at risk of cardiovascular (CV) disease in high-volume ambulatory primary care settings in 3 countries in Central America. Subjects with 2 or more CV risk factors will be identified and will undergo an NYHA score assessment. If the NYHA score is ≥ II, the serum NT-proBNP concentration will be determined on-site on the same day. If the serum NT proBNP concentration is ≥ 125 pg/mL, the subject will be referred to a country specific central echocardiography laboratory for a transthoracic echocardiogram to measure the left ventricular ejection fraction (LVEF) and relevant structural heart disease.
Interventions
Eligibility Criteria
Inclusion Criteria:
Signed informed consent must be obtained prior to participation in the study
Male or female patients aged > 60 years at the time of informed consent
Presence of at least 2 or more of the following risk factors for HF (CV risk factors already diagnosed prior to study visit according to the usual medical practice criteria and listed in the medical chart):
Hypertension
Dyslipidemia
Obesity
Vascular disease, including coronary artery disease, cerebrovascular disease, and peripheral vascular disease
Type 1 or 2 diabetes mellitus
Chronic kidney disease
Arrhythmia requiring therapy
Moderate to severe valvular disease
History of alcohol abuse,
History of smoking,
History of cancer chemotherapy, or
i. History of thoracic radiotherapy l. Abnormal findings in the most recent ECG or m. Abnormal findings in the most recent thoracic X-ray
Attendance at a primary care consultation for reasons not related to HF
Exclusion Criteria:
Previous diagnosis of HF
Diagnosis of terminal cancer (malignant tumor that may cause the subject's death in a short period: days, weeks, or a few months)
Echocardiogram performed within the 12 months before the primary care consultation
Study Locations
Contacts
Have a question?
Call 1-999-669-6682 or email [email protected]