NCT03015311: STEP

Strategy of Blood Pressure Intervention in the Elderly Hypertensive Patients

Status unknown NA Last updated 28 July 2021

What this trial tests

NA trial testing Intensive BP control in Primary Hypertension in 8,000 participants. Status unknown.

Timeline

15 January 2017

Primary endpoint
31 December 2020

31 December 2021

Quick facts

Lead sponsor	Chinese Academy of Medical Sciences, Fuwai Hospital
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	8,000
Start date	15 January 2017
Primary completion	31 December 2020
Estimated completion	31 December 2021
Sites	42 locations across China

Drugs / interventions tested

• Intensive BP control — full drug profile →
• Standard BP control — full drug profile →

Conditions studied

• Primary Hypertension — all drugs for Primary Hypertension →

Sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Who can join

Adults 60 to 80, any sex, with Primary Hypertension. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The Strategy of Blood Pressure Intervention in the Elderly Hypertensive Patients (STEP) is a 2-arm, multi-center, prospective, randomized, open-labeled, blinded-endpoint trial. The purpose of this trial is to test whether a treatment program aimed at reducing systolic blood pressure (SBP) to a lower goal (\<130 mmHg, intensive treatment) than currently recommended (\<150 mmHg, standard treatment) will reduce CVD risk among persons between 60-80 years of old. Furthermore, this trial will also examine the effect of blood pressure APP management strategy via WeChat network on medication compliance, blood pressure control and CVD benefits.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Trial of Intensive Blood-Pressure Control in Older Patients with Hypertension.
   Zhang W, Zhang S, Deng Y, Wu S, et al · · 2021 · cited 547× · PMID 34491661 · DOI 10.1056/nejmoa2111437
2. Sex Differences in Myocardial and Vascular Aging.
   Ji H, Kwan AC, Chen MT, Ouyang D, et al · · 2022 · cited 139× · PMID 35175845 · DOI 10.1161/circresaha.121.319902
3. Landscape of cardiometabolic risk factors in Chinese population: a narrative review.
   Li JJ, Liu HH, Li S. · · 2022 · cited 59× · PMID 35729555 · DOI 10.1186/s12933-022-01551-3
4. Strategy of blood pressure intervention in the elderly hypertensive patients (STEP): Rational, design, and baseline characteristics for the main trial.
   Zhang S, Wu S, Ren J, Chen X, et al · · 2020 · cited 33× · PMID 31838255 · DOI 10.1016/j.cct.2019.105913
5. Blood pressure targets for the treatment of people with hypertension and cardiovascular disease.
   Saiz LC, Gorricho J, Garjón J, Celaya MC, et al · · 2020 · cited 26× · PMID 32905623 · DOI 10.1002/14651858.cd010315.pub4
6. Blood pressure targets for the treatment of people with hypertension and cardiovascular disease.
   Saiz LC, Gorricho J, Garjón J, Celaya MC, et al · · 2018 · cited 26× · PMID 30027631 · DOI 10.1002/14651858.cd010315.pub3
7. Mobile phone-based interventions for improving adherence to medication prescribed for the primary prevention of cardiovascular disease in adults.
   Palmer MJ, Machiyama K, Woodd S, Gubijev A, et al · · 2021 · cited 25× · PMID 33769555 · DOI 10.1002/14651858.cd012675.pub3
8. Anxiety, home blood pressure monitoring, and cardiovascular events among older hypertension patients during the COVID-19 pandemic.
   Zhang S, Zhong Y, Wang L, Yin X, et al · · 2022 · cited 24× · PMID 35064249 · DOI 10.1038/s41440-022-00852-0