Ignite Creation Date:
2024-05-06 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06203860
Status:
RECRUITING
Last Update Posted:
2024-01-12
First Post:
2023-12-10
Brief Title:
The Cardio-Metabolic Clinic
Sponsor:
Odense University Hospital
Organization:
Odense University Hospital
Study Overview
Official Title:
Cardiovascular Protection in Patients With Type 2 Diabetes and Established Heart or Vascular Disease - The Cardio-Metabolic Clinic
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ProtecT-2-D
Brief Summary:
This study aims to investigate whether a Cardio-Metabolic Clinic can protect the cardiovascular health of patients with both diabetes and cardiovascular disease
At the Cardio-Metabolic Clinic patients will receive a specialized and comprehensive care This includes applying a systematic approach considering their whole health based on the latest knowledge in the field and administering aggressive treatment with heart protective medications
The ProtecT-2-D trial will compare the effects of care at the Cardio-Metabolic Clinic to usual care to see if there are any differences in cardiovascular illness and death
At the Cardio-Metabolic Clinic patients will receive a specialized and comprehensive care This includes applying a systematic approach considering their whole health based on the latest knowledge in the field and administering aggressive treatment with heart protective medications
The ProtecT-2-D trial will compare the effects of care at the Cardio-Metabolic Clinic to usual care to see if there are any differences in cardiovascular illness and death
Detailed Description:
Background
Despite improved treatment options cardiovascular disease remains the leading cause of illness and death among patients with type 2 diabetes It is crucial to recognize that managing diabetes involves more than just controlling blood sugar levels preventing and treating cardiovascular disease is of significant importance Lifestyle changes have been proven to have a substantial impact on cardiovascular health Additionally remarkable advancements in treatment options with cardiovascular protective effects have occurred over the past five years Nevertheless the traditional healthcare system primarily focuses on managing individual diseases often leading to fragmented care for patients with type 2 diabetes This fragmented approach often results in inadequate treatment higher costs and worse outcomes for cardiovascular disease To address these challenges our goal is to establish a Cardio-Metabolic Clinic that adopts a multidisciplinary approach to optimize diabetes management The clinic will place special emphasis on implementing measures to protect the cardiovascular system and ensure comprehensive care for the patients By bridging the gap between diabetes management and cardiovascular health the aim is to enhance cardiovascular outcomes for patients with type 2 diabetes
Organization in the Cardio-Metabolic Clinic
The Cardio-Metabolic Clinic structured on a cost-effective model operates through a three-layered system centered on the patient The innermost layer involves medical students or specialized cardio-metabolic nurses who maintain the daily contact with the patients Patient medical history and baseline visit data are recorded in the Electronic Case-Report Form Redcap Upon randomization to the intervention arm a decision-making algorithm in the Redcap-system is activated ensuring that patients receive optimal and tailored medical treatment in accordance with the latest guidelines for diabetes management The second layer includes a cardiologist who in collaboration with the medical students or cardio-metabolic nurses reviews the patients risk profiles and algorithm-recommended treatments If further counselling is needed for patient management the third layer consisting of an endocrinologist a nephrologist and a hepatologist will be consulted This multidisciplinary collaboration ensures the most optimal diabetes management especially in challenging cases
Objectives
The objective of the ProtecT-2-D trial is to investigate whether a comprehensive care in a Cardio-Metabolic Clinic are superior to standard treatment in reducing cardiovascular morbidity and mortality
Hypothesis
In patients with type 2 diabetes and cardiovascular disease a systematic specialized multidisciplinary approach in a Cardio-Metabolic Clinic will result in better management of diabetes and reduced cardiovascular morbidity and mortality
Methods
The ProtecT-2-D study is a prospective randomized controlled trial conducted at the Cardiovascular Research Unit in Svendborg Hospital Denmark The study population consists of patients with type 2 diabetes and established cardiovascular disease referred from general practices or seen in the outpatient clinic of Cardiology or Endocrinology at Svendborg Hospital Sixteen hundred patients are anticipated to take part in the study Patients are randomized in a 21 ratio to either receive comprehensive care at the Cardio-Metabolic Clinic or standard treatment All patients are invited to undergo a health examination at baseline Subsequently patients enrolled in the Cardio-Metabolic Clinic will undergo a thorough multidisciplinary evaluation including an optimization of lifestyle factors and medical treatment of cardiovascular risk factors based on current treatment guidelines
After a duration of 3 years all patients will be invited for a follow-up health examination Furthermore complications related to diabetes or cardiovascular disease will be assessed through registry and journal audits after 5 and 10 years
Outcomes
The primary outcome of the ProtecT-2-D trial is to investigate whether comprehensive care in a Cardio-Metabolic Clinic is superior to standard treatment This will be assessed by the time to first occurrence of any of the endpoints in this composite Death from cardiovascular causes non-fatal myocardial infarction non-fatal stroke and hospitalization for HF
Sample size estimation
A reduction in the primary endpoint of 15 is anticipated in patients assessed in the Cardio-Metabolic Clinic compared to standard treatment With a power of 80 and an alpha value of 005 1306 patients are needed and a dropout rate of around 15-20 is anticipated therefore 1600 patients will have to be included in the study
Despite improved treatment options cardiovascular disease remains the leading cause of illness and death among patients with type 2 diabetes It is crucial to recognize that managing diabetes involves more than just controlling blood sugar levels preventing and treating cardiovascular disease is of significant importance Lifestyle changes have been proven to have a substantial impact on cardiovascular health Additionally remarkable advancements in treatment options with cardiovascular protective effects have occurred over the past five years Nevertheless the traditional healthcare system primarily focuses on managing individual diseases often leading to fragmented care for patients with type 2 diabetes This fragmented approach often results in inadequate treatment higher costs and worse outcomes for cardiovascular disease To address these challenges our goal is to establish a Cardio-Metabolic Clinic that adopts a multidisciplinary approach to optimize diabetes management The clinic will place special emphasis on implementing measures to protect the cardiovascular system and ensure comprehensive care for the patients By bridging the gap between diabetes management and cardiovascular health the aim is to enhance cardiovascular outcomes for patients with type 2 diabetes
Organization in the Cardio-Metabolic Clinic
The Cardio-Metabolic Clinic structured on a cost-effective model operates through a three-layered system centered on the patient The innermost layer involves medical students or specialized cardio-metabolic nurses who maintain the daily contact with the patients Patient medical history and baseline visit data are recorded in the Electronic Case-Report Form Redcap Upon randomization to the intervention arm a decision-making algorithm in the Redcap-system is activated ensuring that patients receive optimal and tailored medical treatment in accordance with the latest guidelines for diabetes management The second layer includes a cardiologist who in collaboration with the medical students or cardio-metabolic nurses reviews the patients risk profiles and algorithm-recommended treatments If further counselling is needed for patient management the third layer consisting of an endocrinologist a nephrologist and a hepatologist will be consulted This multidisciplinary collaboration ensures the most optimal diabetes management especially in challenging cases
Objectives
The objective of the ProtecT-2-D trial is to investigate whether a comprehensive care in a Cardio-Metabolic Clinic are superior to standard treatment in reducing cardiovascular morbidity and mortality
Hypothesis
In patients with type 2 diabetes and cardiovascular disease a systematic specialized multidisciplinary approach in a Cardio-Metabolic Clinic will result in better management of diabetes and reduced cardiovascular morbidity and mortality
Methods
The ProtecT-2-D study is a prospective randomized controlled trial conducted at the Cardiovascular Research Unit in Svendborg Hospital Denmark The study population consists of patients with type 2 diabetes and established cardiovascular disease referred from general practices or seen in the outpatient clinic of Cardiology or Endocrinology at Svendborg Hospital Sixteen hundred patients are anticipated to take part in the study Patients are randomized in a 21 ratio to either receive comprehensive care at the Cardio-Metabolic Clinic or standard treatment All patients are invited to undergo a health examination at baseline Subsequently patients enrolled in the Cardio-Metabolic Clinic will undergo a thorough multidisciplinary evaluation including an optimization of lifestyle factors and medical treatment of cardiovascular risk factors based on current treatment guidelines
After a duration of 3 years all patients will be invited for a follow-up health examination Furthermore complications related to diabetes or cardiovascular disease will be assessed through registry and journal audits after 5 and 10 years
Outcomes
The primary outcome of the ProtecT-2-D trial is to investigate whether comprehensive care in a Cardio-Metabolic Clinic is superior to standard treatment This will be assessed by the time to first occurrence of any of the endpoints in this composite Death from cardiovascular causes non-fatal myocardial infarction non-fatal stroke and hospitalization for HF
Sample size estimation
A reduction in the primary endpoint of 15 is anticipated in patients assessed in the Cardio-Metabolic Clinic compared to standard treatment With a power of 80 and an alpha value of 005 1306 patients are needed and a dropout rate of around 15-20 is anticipated therefore 1600 patients will have to be included in the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None