Clinical trial NCT04143919: Heart Failure IDentification in a High Risk Cardiovascular OutpatiEnt Population (HIDE)
Official title: Heart Failure IDentification in a High Risk Cardiovascular OutpatiEnt Population (HIDE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: Heart failure
Cardiovascular risk factors
NT-proBNP
NYHA assessment
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2019-10-30
Enrollment: 317
Sex: ALL
Minimum age (years): 61
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A recent Cochrane analysis reported a high burden of HF in Latin America (Ciapponi et al 2016), reporting an incidence of HF of 199 cases per 100 000 person-years. A cross-sectional study of 633 individuals aged ≥ 45 years, randomly selected and registered in a primary care program in Brazil (Jorge et al 2016) reported 36.6% of patients with Stage A HF, 42.7% with Stage B, and and 9.3% with symptomatic HF (Stage C). In real world settings primary care physician may attend to up to 40 patients per day, which rose to as many as 70 patients per day during high season demand, meaning in some circunstances physicians may only have up to 12 minutes per patient so patients with HF may go unnoticed. The aim of this study is to assess the practicality of an algorithm to identify new cases of HF Stage C in subjects who are at risk of CV disease in real world high-volume ambulatory primary care settings in Central America.
Primary purpose: SCREENING

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.

Eligibility criteria: Inclusion Criteria:

1. Signed informed consent must be obtained prior to participation in the study
2. Male or female patients aged \> 60 years at the time of informed consent
3. 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):

   1. Hypertension
   2. Dyslipidemia
   3. Obesity
   4. Vascular disease, including coronary artery disease, cerebrovascular disease, and peripheral vascular disease
   5. Type 1 or 2 diabetes mellitus
   6. Chronic kidney disease
   7. Arrhythmia requiring therapy
   8. Moderate to severe valvular disease
   9. History of alcohol abuse,
   10. History of smoking,
   11. 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
4. Attendance at a primary care consultation for reasons not related to HF

Exclusion Criteria:

1. Previous diagnosis of HF
2. Diagnosis of terminal cancer (malignant tumor that may cause the subject's death in a short period: days, weeks, or a few months)
3. Echocardiogram performed within the 12 months before the primary care consultation

Primary outcomes:
measure: Number of Cases of HF stage C
timeFrame: 5 months
Secondary outcomes:
measure: Comparison of number of subjects diagnosed with HF stage C
timeFrame: 5 months
measure: Percentage of subjects with CV risk factos
timeFrame: 5 months
measure: Percentage of subjects with CV risk factors among participating countries
timeFrame: 5 months
measure: Ratio of subjects with each listed CV risk factor between subjects with and without HF Stage C
timeFrame: 5 months
measure: Incidence of equality of HF Stage C among participating countries
timeFrame: 5 months
measure: Mean NT-proBNP levels among subjects diagnosed with HF Stage C versus subjects with no HF
timeFrame: 5 months
Other outcomes:
Locations:
city: Santo Domingo
country: Dominican Republic
facility: Novartis Investigative Site
city: Santo Domingo
country: Dominican Republic
facility: Novartis Investigative Site
city: San Salvador
country: El Salvador
facility: Novartis Investigative Site
city: Guatemala City
country: Guatemala
facility: Novartis Investigative Site
city: Guatemala city
country: Guatemala
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceutical
name: Novartis Pharmaceutical
role: STUDY_DIRECTOR
References: