A Multi-center, Prospective, Observational Study to Describe the siTuation of Blood Lipid mAnagement Among the Population With hypeRtension and/or Type 2 diabeTes in Community Health Center

Sponsor

Huashan Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05081440

Collaborator

Pfizer (Industry)

5,000

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

A multi-center, prospective, observational Study to describe the siTuation of blood lipid mAnagement among the population with hypeRtension and/or type 2 diabeTes in Community Health Center

Condition or Disease	Intervention/Treatment	Phase
Lipoprotein Disorder

Study Design

Study Type:

Observational

Anticipated Enrollment :

5000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

A Multi-center, Prospective, Observational Study to Describe the siTuation of Blood Lipid mAnagement Among the Population With hypeRtension and/or Type 2 diabeTes in Community Health Center(START-CHC)

Anticipated Study Start Date :

Dec 1, 2021

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
patients diagnosed with hypertension or diabetes Age ≥18 years; Patients with well-diagnosed hypertension (HTN) and/or type 2 diabetes (T2DM) and have been ill for ≥ 3 months; The patient underwent fasting lipid analysis in the past 1 month and the data was fully recorded

Outcome Measures

Primary Outcome Measures

primary outcome [2022.12.01]
To evaluate the blood lipid levels and current status of drug treatment in patients with CHC hypertension and/or type 2 diabetes Describe the characteristics of blood lipid treatment in patients with CHC with hypertension and/or type 2 diabetes with LDL-C between 2.6 and 4.1 mmol/L

Secondary Outcome Measures

secondary outcome [2022.12.01]
To evaluate the ASCVD risk stratification and the level of blood lipids in patients with CHC hypertension and/or type 2 diabetes. Evaluate the blood lipid level of patients with hypertension and/or type 2 diabetes in CHC with LDL-C between 2.6 and 4.1mmol/L (LDL-C/Non-HDL) To explore the compliance of patients with CHC hypertension and/or type 2 diabetes with LDL-C between 2.6 and 4.1 mmol/L for lipid-lowering therapy.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

The informed consent form (ICF) should be signed before conducting any research-related operations
Age ≥18 years
Patients with well-diagnosed hypertension (HTN) and/or type 2 diabetes (T2DM) and have been ill for ≥ 3 months
The patient underwent fasting lipid analysis in the past 1 month and the data was fully recorded

Exclusion Criteria:

1.Patients with well-diagnosed atherosclerotic cardiovascular disease (ASCVD) 2. Have received any form of lipid-lowering treatment within 4 weeks before the screening period 3. The patient is currently participating in any other clinical trial except this study

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Huashan Hospital
Pfizer

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yong Li, PhD, MD, Huashan Hospital

ClinicalTrials.gov Identifier:

NCT05081440

Other Study ID Numbers:

START-CHC

First Posted:

Oct 18, 2021

Last Update Posted:

Oct 18, 2021

Last Verified:

Oct 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hypertension

Study Results

No Results Posted as of Oct 18, 2021