A Study to Characterize the Prevalence of Overweight and Obesity Among Patients With Established Cardiovascular Disease

NCT05873660 | Completed

• 2 other identifiers: DAS-7537U1111-1283-8551
• Study Type: observational
• Target: 5,360
• Locations: 5 countries
• Sites: 5

Brief Summary

The purpose of this observational study is to measure how many people are overweight or obese amongst patients with a diagnosed cardiovascular disease (CVD). The study also aims to characterise the population including the presence of cardiovascular (CV) risk factors in a number of countries across the globe representing different geographies, ethnicities, as well as different healthcare systems.

Conditions

Obesity; Overweight

Outcome Measures

Primary Outcomes (1)

• Overweight and obesity among patients with established CVD pooled across all countries

  % of patients

  At the time of patient enrolment (Day 1/Visit 1)

Study Arms (1)

People with established CVD

Adults diagnosed with established CVD, attending routine medical care or follow-up in a cardiology clinic.

Other: No treatment given

Interventions

No treatment given OTHER

No treatment given

People with established CVD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of adults aged 18 years or older diagnosed with established cardiovascular disease (CVD) and are attending routine medical care or follow-up in a cardiology clinic.

You may qualify if:

• Informed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
• Adults, age above or equal to 18 years at the time of signing informed consent.
• Have established CVD and equal to or greater than 1 follow up appointment following an acute event from at least one of the following:
• Prior myocardial infarction
• Prior stroke (ischemic or haemorrhagic stroke)
• Symptomatic peripheral arterial disease (PAD), as evidenced by intermittent claudication with ankle-brachial index (ABI) below 85 (at rest), or peripheral arterial revascularization procedure, or amputation due to atherosclerotic disease

You may not qualify if:

• Previous participation in this study. Participation is defined as having given informed consent in this study
• Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
• Patients with known congenital heart disease/malformation

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (5)

Novo Nordisk Investigational Site

Plainsboro, New Jersey, 08536, United States

Location

Novo Nordisk Investigational Site

São Paulo, Brazil

Location

Novo Nordisk Investigational Site

Ontario, Canada

Location

Novo Nordisk Investigational Site

Riyadh, Saudi Arabia

Location

Novo Nordisk Investigational Site

Madrid, Spain

Location

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2023
• First Posted: May 24, 2023
• Study Start: June 12, 2023
• Primary Completion: June 24, 2024
• Study Completion: June 24, 2024
• Last Updated: July 11, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share

Locations

ES (1); CA (1); SA (1); BR (1); US (1)