Study S002571

Effects and Safety of GUideline Algorithm Based Intervention on CaRdiovascular and Renal Outcomes in Elderly Diabetic Patients With High Cardiovascular Risk in the Community- A Cluster Randomized Controlled Trial (GUARD-Community Study)

ClinicalTrials.gov record

Registration

Registration: NCT05349955
Acronym: GUARD
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Masking: SINGLE
Status: RECRUITING
Enrollment: 5600
Start: 2022-11-21
Primary completion: 2026-11-30
Lead sponsor: Shanghai Zhongshan Hospital
Conditions: Type 2 Diabetes; Cardiovascular Complication; Diabetic Kidney Disease
Interventions: OTHER:Intensive guideline algorithm implementation; OTHER:Conventional guideline algorithm implementation
Results posted: FALSE
Individual participant data sharing: NO

Registered primary outcomes

Primary Outcome of Phase 1: Comprehensive management effect of various cardiovascular risk factors in T2D，meeting control targets for a combination of A1c, BP, LDL-C. [18 months since randomization]
Primary Outcome of Phase 2: Composite of 3P MACE and hospitalization for heart failure. [3 years since randomization]

Linked records (3)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.

Record	Title	Year	Design	Identifiers	Link basis
R0018537	Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND): a double-blind, randomised placebo-controlled trial. Gerstein HC, Lancet (London, England)	2019	Randomized trial	PMID 31189511 DOI	registry reference BACKGROUND:31189511
R0022060	Liraglutide and Cardiovascular Outcomes in Type 2 Diabetes. Marso SP, The New England journal of medicine	2016	Randomized trial	PMID 27295427 DOI	registry reference BACKGROUND:27295427
R0022278	Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes. Marso SP, The New England journal of medicine	2016	Randomized trial	PMID 27633186 DOI	registry reference BACKGROUND:27633186