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

NCT04143919 | Completed

• 1 other identifier: CLCZ696DGT01
• Study Type: interventional
• Target: 317
• Locations: 3 countries
• Sites: 5

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.

Conditions

Heart Failure

Keywords

Heart failure; Cardiovascular risk factors; NT-proBNP; NYHA assessment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

Study Arms (1)

Subjects with CV risk factors

EXPERIMENTAL

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; Procedure: Serum NT-proBNP concentration; Diagnostic Test: Transthoracic Ecocardiogram

Interventions

NYHA assessment DIAGNOSTIC_TEST

The New York Heart Association (NYHA) functional classification of HF

Subjects with CV risk factors

Serum NT-proBNP concentration PROCEDURE

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.

Subjects with CV risk factors

Transthoracic Ecocardiogram DIAGNOSTIC_TEST

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

Subjects with CV risk factors

Eligibility Criteria

• Age: 61 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• i. History of thoracic radiotherapy l. Abnormal findings in the most recent ECG or m. Abnormal findings in the most recent thoracic X-ray

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (5)

Novartis Investigative Site

Santo Domingo, 10203, Dominican Republic

Location

Novartis Investigative Site

Santo Domingo, Dominican Republic

Location

Novartis Investigative Site

San Salvador, 1101, El Salvador

Location

Novartis Investigative Site

Guatemala City, 01009, Guatemala

Location

Novartis Investigative Site

Guatemala City, 01010, Guatemala

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Novartis Pharmaceutical

  Novartis Pharmaceutical

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 28, 2019
• First Posted: October 30, 2019
• Study Start: January 31, 2020
• Primary Completion: June 7, 2021
• Study Completion: June 11, 2021
• Last Updated: March 31, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share

Locations

DO (2); EL (1); GU (2)