Replication of the TRANSCEND Antihypertensive Trial in Healthcare Claims Data

NCT04354376 | Completed FDA Drug

• 1 other identifier: 2018P002966-DUP-TRANSCEND
• Study Type: observational
• Target: 40,048
• Locations: 1 country
• Sites: 1

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 clinical questions real world data analyses can be conducted with confidence and how to implement such studies.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• Relative hazard of composite outcome of Congestive Heart Failure, Stroke, MI, and Mortality

  Relative hazard of composite outcome of Congestive Heart Failure, Stroke, MI, and Mortality - Please refer to uploaded protocol for full definition due to size limitations.

  Through study completion (a median of ***118-123**** days)

Study Arms (2)

Loop diuretics, thiazides, dihydropyridines

Reference group

Drug: Loop diuretics, thiazides, dihydropyridines

Telmisartan

Exposure group

Drug: Telmisartan

Interventions

Loop diuretics, thiazides, dihydropyridines DRUG

Loop diuretics, thiazides, or dihydropyridines dispensing claim is used as the reference

Loop diuretics, thiazides, dihydropyridines

Telmisartan DRUG

Telmisartan dispensing claim is used as the exposure

Telmisartan

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This study will involve a new user, parallel group, propensity score-matched, retrospective cohort study design comparing telmisartan to other antihypertensives, including loop diuretics, thiazides, and dihydropyridines. Although the trial compared telmisartan with placebo added to usual care, the investigators selected an active comparator for this study because non-user comparator groups are known to often lead to confounding by indication and biased treatment effect estimates. This group of other antihypertensives were selected as the primary comparator because intolerance to ACEi was a primary inclusion criteria for the trial. Therefore, patients in both arms were on a mix of non-ACEi and non-ARB antihypertensives as background therapy.

You may qualify if:

• Individuals 55 years of age with 1 of the following:
• \. Coronary artery disease
• a. Previous myocardial infraction ( \> 2 days post uncomplicated MI)
• b. Stable angina or unstable angina \> 30 days before informed consent and with documented evidence of multivessel coronary artery disease
• c. Multi-vessel PTCA \>30 days before informed consent
• d. Multi-vessel CABG surgery \> 4 years before informed consent, or with recurrent angina following surgery
• \. Peripheral artery disease
• a. Previous limb bypass surgery or Previous limb bypass surgery or angioplasty
• b. Previous limb or foot amputation
• c. Intermittent claudication, with ankle:arm BP ratio =\< 0.80 on at least 1 side
• d. Significant peripheral artery stenosis ( \> 50%) documented by angiography or non-invasive testing
• \. Cerebrovascular disease
• a. Previous stroke
• b. Transient ischemic attacks \>7 days and \<1 year before informed consent
• \. Diabetus mellitus

You may not qualify if:

• \. Medication use
• a. Inability to discontinue ACE inhibitors or ARB
• b. Known hypersensitivity or intolerance to ACE inhibitors or ARB (patient intolerant of ACE inhibitor can be enrolled in TRANSCEND)
• \. Cardiovascular disease (HF)
• a. Symptomatic congestive heart failure
• b. Hemodynamically significant primary valvular or outflow tract obstruction
• c. Constrictive pericarditis
• d. Complex congenital heart disease
• e. Syncopal episodes of unknown etiology \<3 months before informed consent
• f. Planned cardiac surgery or PTCA \<3 months of informed consent
• g. Uncontrolled hypertension on treatment (eg, BP \>160/100 mm Hg)
• f. Heart transplant recipient
• g. Stroke due to subarachnoid hemorrhage
• \. Other conditions
• a. Significant renal artery disease

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham And Women's Hospital

Boston, Massachusetts, 02120, United States

Location

MeSH Terms

Conditions

Hypertension

Interventions

Sodium Potassium Chloride Symporter Inhibitors; Thiazides; Dihydropyridines; Telmisartan

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Diuretics; Natriuretic Agents; Physiological Effects of Drugs; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Shirley Wang, PhD, ScM

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: April 17, 2020
• First Posted: April 21, 2020
• Study Start: September 22, 2017
• Primary Completion: February 8, 2021
• Study Completion: February 8, 2021
• Last Updated: July 27, 2023

Record last verified: 2023-07

Locations

US (1)