Heart FailureHIDENCT04143919
Heart Failure IDentification in a High Risk Cardiovascular OutpatiEnt Population (HIDE)
A study testing NYHA assessment, Serum NT-proBNP concentration and Transthoracic Ecocardiogram in people with Heart Failure, run by Novartis Pharmaceuticals at 5 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 61 to 100 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- NYHA assessment, Serum NT-proBNP concentration and Transthoracic Ecocardiogram
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 317 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 31 Jan 2020to 11 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 61 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 16Show fewer
- 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
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
Dominican Republic2 sites
Novartis Investigative Site
Santo Domingo, 10203
Novartis Investigative Site
Santo Domingo
Guatemala2 sites
Novartis Investigative Site
Guatemala City, 01009
Novartis Investigative Site
Guatemala City, 01010
About this study
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.
Read the 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.
- Conditions
- Heart Failure
- Being tested
- NYHA assessment, Serum NT-proBNP concentration, Transthoracic Ecocardiogram
- Keywords
- Heart failure, Cardiovascular risk factors, NT-proBNP, NYHA assessment
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NYHA assessmentDiagnostic test
The New York Heart Association (NYHA) functional classification of HF
Serum NT-proBNP concentrationProcedure or surgery
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 EcocardiogramDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: NYHA assessment; Procedure: Serum NT-proBNP concentration; Diagnostic Test: Transthoracic Ecocardiogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Cases of HF stage C
Proportion of subjects with HF Stage C among those with 2 or more CV risk factors
Measured: 5 months
Secondary outcomes (6)
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
Measured: 5 months
Percentage of subjects with CV risk factos
Percentage of subjects with each listed CV risk factor among those with HF Stage C
Measured: 5 months
Percentage of subjects with CV risk factors among participating countries
Percentage of subjects with each listed CV risk factor among participating countries
Measured: 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
Measured: 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
Measured: 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
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2019
- Study start31 Jan 2020
- Primary completion7 Jun 2021
- Study completion11 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 317 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceutical, Study director, Novartis Pharmaceutical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04143919
- Sponsor's protocol ID
- CLCZ696DGT01
- Acronym
- HIDE
- Status last verified
- Mar 2022
- First submitted
- 28 Oct 2019
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart Failure IDentification in a High Risk Cardiovascular OutpatiEnt Population (HIDE)
- ClinicalTrials.gov ID
- NCT04143919
- Acronym / sponsor ID
- HIDE / CLCZ696DGT01
- Conditions
- Heart Failure
- Keywords
- Heart failure, Cardiovascular risk factors, NT-proBNP, NYHA assessment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 317 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 31 Jan 2020 (actual)
- Primary completion
- 7 Jun 2021 (actual)
- Study completion
- 11 Jun 2021 (actual)
- First posted
- 30 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Subjects with CV risk factors | Experimental | Diagnostic Test: NYHA assessment, Procedure: Serum NT-proBNP concentration, Diagnostic Test: Transthoracic EcocardiogramSubjects 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. |
Who may qualify
- Ages
- 61 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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):
- Attendance at a primary care consultation for reasons not related to HF
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NYHA assessmentThe New York Heart Association (NYHA) functional classification of HF | Diagnostic test | Subjects with CV risk factors |
| Serum NT-proBNP concentrationSubjects 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. | Procedure or surgery | Subjects with CV risk factors |
| Transthoracic EcocardiogramSubjects 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 | Diagnostic test | Subjects with CV risk factors |
Primary outcome
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
6 secondary outcomes
Comparison of number of subjects diagnosed with HF stage C
Time frame: 5 months
Percentage of subjects with CV risk factos
Time frame: 5 months
Percentage of subjects with CV risk factors among participating countries
Time frame: 5 months
Ratio of subjects with each listed CV risk factor between subjects with and without HF Stage C
Time frame: 5 months
Incidence of equality of HF Stage C among participating countries
Time frame: 5 months
Mean NT-proBNP levels among subjects diagnosed with HF Stage C versus subjects with no HF
Time frame: 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceutical study director
Novartis Pharmaceutical
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NYHA assessment, Serum NT-proBNP concentration and Transthoracic Ecocardiogram in people with Heart Failure, run by Novartis Pharmaceuticals at 5 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Dominican Republic, Guatemala, El Salvador. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Cases of HF stage C (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.