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

Completed

• Conditions: Overweight; Obesity
• Interventions: Other: No treatment given

• Registration Number: NCT05873660
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-15
• Study First Submitted QC: 2023-05-15
• Study First Posted: 2023-05-24
• Study Start: 2023-06-12
• Primary Completion: 2024-06-24
• Study Completion: 2024-06-24
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-10
• Last Update Posted: 2024-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5360

Inclusion Criteria

1. Informed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).

2. Adults, age above or equal to 18 years at the time of signing informed consent.

3. 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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
People with established CVD	No treatment given	Adults diagnosed with established CVD, attending routine medical care or follow-up in a cardiology clinic.

Primary Outcome Measures

Name	Time	Method
Overweight and obesity among patients with established CVD pooled across all countries	At the time of patient enrolment (Day 1/Visit 1)	% of patients

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇪🇸 Madrid, Spain