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

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ClinicalTrials.gov Identifier: NCT04143919
Recruitment Status : Recruiting
First Posted : October 30, 2019
Last Update Posted : March 30, 2021
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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 Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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.
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Heart Failure IDentification in a High Risk Cardiovascular OutpatiEnt Population (HIDE)
Actual Study Start Date : January 31, 2020
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

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




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   61 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04143919


Contacts
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Contact: Novartis Pharmaceuticals +41613241111 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals

Locations
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El Salvador
Novartis Investigative Site Recruiting
San Salvador, El Salvador, 1101
Guatemala
Novartis Investigative Site Recruiting
Guatemala city, Guatemala, 01010
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceutical Novartis Pharmaceutical
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04143919    
Other Study ID Numbers: CLCZ696DGT01
First Posted: October 30, 2019    Key Record Dates
Last Update Posted: March 30, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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


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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Heart failure
Cardiovascular risk factors
NT-proBNP
NYHA assessment
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases