Heart Failure IDentification in a High Risk Cardiovascula... | NCT04143919

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

NCT04143919

Sponsor

Novartis Pharmaceuticals

Status

Completed

Last Update Posted

Mar 31, 2022Actual

Enrollment

317Actual

Phase

Not Applicable

Conditions

Heart Failure

Interventions

NYHA assessment
Serum NT-proBNP concentration
Transthoracic Ecocardiogram

Countries

Dominican Republic
El Salvador
Guatemala

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 31, 2020Actual

Primary Completion Date

Jun 7, 2021Actual

Completion Date

Jun 11, 2021Actual

First Submitted Date

Oct 28, 2019

First Submission Date that Met QC Criteria

Oct 28, 2019

First Posted Date

Oct 30, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 17, 2022

Last Update Posted Date

Mar 31, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

317Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.	Diagnostic Test: NYHA assessment Procedure: Serum NT-proBNP concentration Diagnostic Test: Transthoracic Ecocardiogram

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NYHA assessment	Diagnostic Test	The New York Heart Association (NYHA) functional classification of HF	Subjects with CV risk factors

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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):
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
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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

61 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Novartis Pharmaceutical	Novartis Pharmaceutical	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigative Site		Santo Domingo		10203	Dominican Republic
Novartis Investigative Site

IPD Sharing Statement Module

Plan to Share IPD

Yes

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.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D006333	Heart Failure

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

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.