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

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT04143919

Collaborator

(none)

317

Enrollment

Locations

Arm

16.3

Actual Duration (Months)

63.4

Patients Per Site

3.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	Diagnostic Test: NYHA assessment Procedure: Serum NT-proBNP concentration Diagnostic Test: Transthoracic Ecocardiogram	N/A

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

Actual Enrollment :

317 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

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.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.

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

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

Actual Study Start Date :

Jan 31, 2020

Actual Primary Completion Date :

Jun 7, 2021

Actual Study Completion Date :

Jun 11, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Subjects with CV risk factors 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.	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

Arm

Intervention/Treatment

Experimental: Subjects with CV risk factors

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.

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

61 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Novartis Investigative Site	Santo Domingo	Dominican Republic	10203
2	Novartis Investigative Site	Santo Domingo	Dominican Republic
3	Novartis Investigative Site	San Salvador	El Salvador	1101
4	Novartis Investigative Site	Guatemala City	Guatemala	01009
5	Novartis Investigative Site	Guatemala city	Guatemala	01010

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director: Novartis Pharmaceutical, Novartis Pharmaceutical

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Novartis Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT04143919

Other Study ID Numbers:

CLCZ696DGT01

First Posted:

Oct 30, 2019

Last Update Posted:

Mar 31, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Novartis Pharmaceuticals

Heart failure

Cardiovascular risk factors

NT-proBNP

NYHA assessment

Additional relevant MeSH terms:

Heart Failure

Study Results

No Results Posted as of Mar 31, 2022