Heart Failure IDentification in a High Risk Cardiovascular OutpatiEnt Population (HIDE)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 317
- Locations
- 6
- Primary Endpoint
- Number of Cases of HF stage C
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- 61 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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
Outcomes
Primary Outcomes
Number of Cases of HF stage C
Time Frame: 5 months
Proportion of subjects with HF Stage C among those with 2 or more CV risk factors
Secondary Outcomes
- Comparison of number of subjects diagnosed with HF stage C(5 months)
- Percentage of subjects with CV risk factos(5 months)
- Percentage of subjects with CV risk factors among participating countries(5 months)
- Ratio of subjects with each listed CV risk factor between subjects with and without HF Stage C(5 months)
- Incidence of equality of HF Stage C among participating countries(5 months)
- Mean NT-proBNP levels among subjects diagnosed with HF Stage C versus subjects with no HF(5 months)