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Strategy of blood pressure intervention in the elderly hypertensive patients (STEP): Rational, design, and baseline characteristics for the main trial.
- Source :
-
Contemporary clinical trials [Contemp Clin Trials] 2020 Feb; Vol. 89, pp. 105913. Date of Electronic Publication: 2019 Dec 12. - Publication Year :
- 2020
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Abstract
- The optimal systolic blood pressure (SBP) treatment target in elderly people is full of challenge, and non-adherence is one major cause of uncontrolled BP. The Strategy of Blood Pressure Intervention in the Elderly Hypertensive Patients (STEP) trial is a multi-center, randomized controlled trial that aims to examine whether an intensive treatment (110 ≤ SBP < 130 mmHg) will provide more benefits in lowering cardiovascular events than a mild treatment (130 ≤ SBP < 150 mmHg) among people aged 60-80 years. From January 10, 2017 to December 31, 2017, 8511 patients with primary hypertension were recruited at 42 clinical centers throughout China and randomly assigned to the intensive or standard treatment in 1:1 ratio, in which clinical sites are considered as a stratification factor in randomization. Participants will be followed for an average of four years. All participants used the same validated home BP device and all centers used the same validated office BP device which can automatically upload the readings to a data center. The hospitals were randomly classified as the smartphone-based App center or usual care center in 1:1 ratio for the secondary purpose to study the effect of App management on BP control. In this trial, mean age of participants was 66.2 ± 4.8 years, 24.1% were in the range of 70-80 years, and 65% were at high-risk with the 10-year Framingham risk score ≥ 15%. In conclusion, STEP will provide evidence not only to address appropriate target of BP control among hypertensive patients aged 60-80 years, but also to assess an effective model of App management for hypertension. Trial Registration number: ClinicalTrials. gov. Unique identifier: NCT03015311.<br />Competing Interests: Declaration of Competing Interest None declared.<br /> (Copyright © 2019 The Authors. Published by Elsevier Inc. All rights reserved.)
- Subjects :
- Aged
Aged, 80 and over
Female
Humans
Male
Middle Aged
Blood Pressure
Blood Pressure Determination
China
Comorbidity
Research Design
Smartphone
Randomized Controlled Trials as Topic
Multicenter Studies as Topic
Antihypertensive Agents administration & dosage
Antihypertensive Agents therapeutic use
Hypertension drug therapy
Medication Adherence
Mobile Applications
Subjects
Details
- Language :
- English
- ISSN :
- 1559-2030
- Volume :
- 89
- Database :
- MEDLINE
- Journal :
- Contemporary clinical trials
- Publication Type :
- Academic Journal
- Accession number :
- 31838255
- Full Text :
- https://doi.org/10.1016/j.cct.2019.105913