Status:
COMPLETED
Replication of the TRANSCEND Antihypertensive Trial in Healthcare Claims Data
Lead Sponsor:
Brigham and Women's Hospital
Conditions:
Hypertension
Eligibility:
All Genders
55+ years
Brief Summary
Investigators are building an empirical evidence base for real world data through large-scale replication of randomized controlled trials. The investigators' goal is to understand for what types of cl...
Detailed Description
This is a non-randomized, non-interventional study that is part of the RCT DUPLICATE initiative (www.rctduplicate.org) of the Brigham and Women's Hospital, Harvard Medical School. It is intended to re...
Eligibility Criteria
Inclusion
- Please see: https://drive.google.com/drive/folders/1WD618wrywYjEaXzfLTcuK-VCcnb6b-gV for full code and algorithm definitions.
- The patients will be required to have continuous enrollment during baseline period of 180 days before initiation of telmisartan or a comparator drug (cohort entry).
- Eligible cohort entry dates: Market availability of telmistartan in the U.S. started on November 10, 1998, however, the Marketscan and Optum data are available at BWH only from Jan 1, 2003 and Jan 1, 2004, respectively.
- For Marketscan: Jan 1, 2003 -Dec 2017 (end of data availability). For Optum: Jan 1, 2004-June 30, 2019 (end of data availability).
- Individuals 55 years of age with 1 of the following:
- 1\. Coronary artery disease
- 1a. Previous myocardial infraction ( \> 2 days post uncomplicated MI)
- 1b. Stable angina or unstable angina \> 30 days before informed consent and with documented evidence of multivessel coronary artery disease
- 1c. Multi-vessel PTCA \>30 days before informed consent
- 1d. Multi-vessel CABG surgery \> 4 years before informed consent, or with recurrent angina following surgery
- 2\. Peripheral artery disease
- 2a. Previous limb bypass surgery or Previous limb bypass surgery or angioplasty
- 2b. Previous limb or foot amputation
- 2c. Intermittent claudication, with ankle:arm BP ratio =\< 0.80 on at least 1 side
- 2d. Significant peripheral artery stenosis ( \> 50%) documented by angiography or non-invasive testing
- 3\. Cerebrovascular disease
- 3a. Previous stroke
- 3b. Transient ischemic attacks \>7 days and \<1 year before informed consent
- 4\. Diabetus mellitus
- 4a. Diabetes mellitus High-risk diabetics with evidence of endorgan damage
Exclusion
- 1\. Medication use
- 1a. Inability to discontinue ACE inhibitors or ARB
- 1b. Known hypersensitivity or intolerance to ACE inhibitors or ARB (patient intolerant of ACE inhibitor can be enrolled in TRANSCEND)
- 2\. Cardiovascular disease (HF)
- 2a. Symptomatic congestive heart failure
- 2b. Hemodynamically significant primary valvular or outflow tract obstruction
- 2c. Constrictive pericarditis
- 2d. Complex congenital heart disease
- 2e. Syncopal episodes of unknown etiology \<3 months before informed consent
- 2f. Planned cardiac surgery or PTCA \<3 months of informed consent
- 2g. Uncontrolled hypertension on treatment (eg, BP \>160/100 mm Hg)
- 2f. Heart transplant recipient
- 2g. Stroke due to subarachnoid hemorrhage
- 3\. Other conditions
- 3a. Significant renal artery disease
- 3b. Hepatic dysfunction
- 3c. Uncorrected volume or sodium depletion
- 3d. Primary hyperaldosteronism
- 3e. Hereditary fructose intolerance
- 3f. Other major noncardiac illness expected to reduce life expectancy or interfere with study participation
- 3g. Simultaneously taking another experimental drug
- 3h. Significant disability precluding regular follow-up visits
- 3I. Unable or unwilling to provide written informed consent
Key Trial Info
Start Date :
September 22 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 8 2021
Estimated Enrollment :
40048 Patients enrolled
Trial Details
Trial ID
NCT04354376
Start Date
September 22 2017
End Date
February 8 2021
Last Update
July 27 2023
Active Locations (1)
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1
Brigham And Women's Hospital
Boston, Massachusetts, United States, 02120