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

Heart Failure Clinical Trial

— HIDE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04143919
• Other study ID #: CLCZ696DGT01
• Status: Completed
• Phase: N/A
• Start date: January 31, 2020
• Est. completion date: June 11, 2021

Study information

• Verified date: March 2022
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 317
• Est. completion date: June 11, 2021
• Est. primary completion date: June 7, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 61 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Diagnostic Test:
• NYHA assessment
The New York Heart Association (NYHA) functional classification of HF

Procedure:
• Serum NT-proBNP concentration
Subjects with NYHA score = II will undergo a rapid, on site serum NT-proBNP test on the same day of the visit. Roche CARDIAC proBNP+ test, using the Cobas h 232 device, is a quantitative immunological test for the determination of NT-proBNP in heparinized venous blood.

Diagnostic Test:
• Transthoracic Ecocardiogram
Subjects with a serum NT-proBNP result of = 125 pg/mL at Visit 1 will be referred to a study cardiologist for a transthoracic echocardiogram to assess LVEF and relevant structural heart disease

Locations

Country	Name	City	State
Dominican Republic	Novartis Investigative Site	Santo Domingo
Dominican Republic	Novartis Investigative Site	Santo Domingo
El Salvador	Novartis Investigative Site	San Salvador
Guatemala	Novartis Investigative Site	Guatemala City
Guatemala	Novartis Investigative Site	Guatemala city

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Dominican Republic,  El Salvador,  Guatemala, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Cases of HF stage C	Proportion of subjects with HF Stage C among those with 2 or more CV risk factors	5 months
Secondary	Comparison of number of subjects diagnosed with HF stage C	Comparison of the number of subjects diagnosed with l HF Stage C versus the time matched historical proportion at the same study sites	5 months
Secondary	Percentage of subjects with CV risk factos	Percentage of subjects with each listed CV risk factor among those with HF Stage C	5 months
Secondary	Percentage of subjects with CV risk factors among participating countries	Percentage of subjects with each listed CV risk factor among participating countries	5 months
Secondary	Ratio of subjects with each listed CV risk factor between subjects with and without HF Stage C	Ratio of presence versus absence of each listed CV risk factor between subjects with overall HF Stage C and without HF	5 months
Secondary	Incidence of equality of HF Stage C among participating countries	Proportion and equality of proportions of HF Stage C subjects among participating countries	5 months
Secondary	Mean NT-proBNP levels among subjects diagnosed with HF Stage C versus subjects with no HF	Comparison of the mean NT-proBNP (= 125 pg/mL) levels among subjects diagnosed with overall HF Stage C versus subjects with no HF	5 months