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

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Diagnostic test: NYHA assessment; Procedure: Serum NT-proBNP concentration; Diagnostic test: Transthoracic Ecocardiogram

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 Type: Interventional
• Enrollment (Actual): 317
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Dominican Republic
  • Santo Domingo, Dominican Republic
    • Novartis Investigative Site
  • Santo Domingo, Dominican Republic, 10203
    • Novartis Investigative Site
• El Salvador
  • San Salvador, El Salvador, 1101
    • Novartis Investigative Site
• Guatemala
  • Guatemala City, Guatemala, 01009
    • Novartis Investigative Site
  • Guatemala city, Guatemala, 01010
    • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 61 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Percentage of subjects with CV risk factos	Percentage of subjects with each listed CV risk factor among those with HF Stage C	5 months
Percentage of subjects with CV risk factors among participating countries	Percentage of subjects with each listed CV risk factor among participating countries	5 months
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
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
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

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceutical, Novartis Pharmaceutical

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2020
• Primary Completion (Actual): June 7, 2021
• Study Completion (Actual): June 11, 2021

Study Registration Dates

• First Submitted: October 28, 2019
• First Submitted That Met QC Criteria: October 28, 2019
• First Posted (Actual): October 30, 2019

Study Record Updates

• Last Update Posted (Actual): March 31, 2022
• Last Update Submitted That Met QC Criteria: March 17, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Heart failure; Cardiovascular risk factors; NT-proBNP; NYHA assessment
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: CLCZ696DGT01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No