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

NCT04143919 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 317

Last updated 2022-03-31

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceutical · Novartis Pharmaceutical

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
61 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-31
Primary Completion
2021-06-07
Completion
2021-06-11

Countries

  • Dominican Republic
  • El Salvador
  • Guatemala

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04143919 on ClinicalTrials.gov