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NCT Number: NCT04143919

Heart Failure IDentification in a High Risk Cardiovascular OutpatiEnt Population (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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

61 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Novartis Investigative Site, Santo Domingo, Dominican Republic

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

i. 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

Treatment and study plan

NYHA assessment

Diagnostic Test

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

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.

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

Primary outcomes

  1. Number of Cases of HF stage C

    Time frame: 5 months

    Proportion of subjects with HF Stage C among those with 2 or more CV risk factors

Secondary outcomes

  1. Comparison of number of subjects diagnosed with HF stage C

    Time frame: 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

  2. Percentage of subjects with CV risk factos

    Time frame: 5 months

    Percentage of subjects with each listed CV risk factor among those with HF Stage C

  3. Percentage of subjects with CV risk factors among participating countries

    Time frame: 5 months

    Percentage of subjects with each listed CV risk factor among participating countries

  4. Ratio of subjects with each listed CV risk factor between subjects with and without HF Stage C

    Time frame: 5 months

    Ratio of presence versus absence of each listed CV risk factor between subjects with overall HF Stage C and without HF

  5. Incidence of equality of HF Stage C among participating countries

    Time frame: 5 months

    Proportion and equality of proportions of HF Stage C subjects among participating countries

  6. Mean NT-proBNP levels among subjects diagnosed with HF Stage C versus subjects with no HF

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Acronym: HIDE

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 30, 2019
Registry last updated
Mar 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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