Heart Failure IDentification in a High Risk Cardiovascular OutpatiEnt Population (HIDE)

Not Applicable

Completed

• Conditions: Heart Failure
• Interventions: Diagnostic Test: NYHA assessment; Procedure: Serum NT-proBNP concentration; Diagnostic Test: Transthoracic Ecocardiogram

• Registration Number: NCT04143919
• Lead Sponsor: Novartis Pharmaceuticals

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 Timeline

• Study First Submitted: 2019-10-28
• Study First Submitted QC: 2019-10-28
• Study First Posted: 2019-10-30
• Study Start: 2020-01-31
• Primary Completion: 2021-06-07
• Study Completion: 2021-06-11
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-17
• Last Update Posted: 2022-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 317

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Subjects with CV risk factors	Serum NT-proBNP concentration	Subjects with 2 or more CV risk factors will be identified. Cardiovascular risk factors include hypertension, dyslipidemia, obesity, vascular disease, diabetes mellitus, chronic kidney disease, arrhythmia requiring therapy, moderate to severe valvular disease, history of alcohol abuse, smoking, cancer chemotherapy, or thoracic radiotherapy, and abnormal findings in the most recent ECG or thoracic X-ray.
Subjects with CV risk factors	Transthoracic Ecocardiogram	Subjects with 2 or more CV risk factors will be identified. Cardiovascular risk factors include hypertension, dyslipidemia, obesity, vascular disease, diabetes mellitus, chronic kidney disease, arrhythmia requiring therapy, moderate to severe valvular disease, history of alcohol abuse, smoking, cancer chemotherapy, or thoracic radiotherapy, and abnormal findings in the most recent ECG or thoracic X-ray.
Subjects with CV risk factors	NYHA assessment	Subjects with 2 or more CV risk factors will be identified. Cardiovascular risk factors include hypertension, dyslipidemia, obesity, vascular disease, diabetes mellitus, chronic kidney disease, arrhythmia requiring therapy, moderate to severe valvular disease, history of alcohol abuse, smoking, cancer chemotherapy, or thoracic radiotherapy, and abnormal findings in the most recent ECG or thoracic X-ray.

Primary Outcome Measures

Name	Time	Method
Number of Cases of HF stage C	5 months	Proportion of subjects with HF Stage C among those with 2 or more CV risk factors

Secondary Outcome Measures

Name	Time	Method
Comparison of number of subjects diagnosed with HF stage C	5 months	Comparison of the number of subjects diagnosed with l HF Stage C versus the time matched historical proportion at the same study sites
Percentage of subjects with CV risk factos	5 months	Percentage of subjects with each listed CV risk factor among those with HF Stage C
Percentage of subjects with CV risk factors among participating countries	5 months	Percentage of subjects with each listed CV risk factor among participating countries
Ratio of subjects with each listed CV risk factor between subjects with and without HF Stage C	5 months	Ratio of presence versus absence of each listed CV risk factor between subjects with overall HF Stage C and without HF
Incidence of equality of HF Stage C among participating countries	5 months	Proportion and equality of proportions of HF Stage C subjects among participating countries
Mean NT-proBNP levels among subjects diagnosed with HF Stage C versus subjects with no HF	5 months	Comparison of the mean NT-proBNP (≥ 125 pg/mL) levels among subjects diagnosed with overall HF Stage C versus subjects with no HF

Trial Locations

Locations (1)

Novartis Investigative Site; 🇬🇹 Guatemala city, Guatemala