Clinical trial NCT02088450: Systolic Hypertension in Europe Placebo-Controlled Trial
Official title: Systolic Hypertension in Europe Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Isolated Systolic Hypertension
Keywords: Cardiovascular complications
Clinical trial
Elderly
Isolated systolic hypertension
Stroke
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2014-03-17
Enrollment: 4695
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The Syst-Eur Trial is a concerted action of the European Community's Medical and Health Research Programme. The trial is carried out in consultation with the World Health Organization, the International Society of Hypertension, the European Society of Hypertension and the World Hypertension League. Syst-Eur is a multicentre trial designed by the European Working Party on High Blood Pressure in the Elderly (EWPHE), to test the hypothesis that antihypertensive treatment of elderly patients with isolated systolic hypertension results in a significant change in stroke morbidity and mortality. Secondary endpoints include cardiovascular events, such as myocardial infarction and congestive heart failure. To be eligible patients must be at least 60 years old and have a systolic blood pressure averaging 160-219 mmHg with a diastolic pressure less than 95 mmHg. Patients must give their informed consent and be free of major cardiovascular and non-cardiovascular diseases at entry. The patients are randomized to active treatment or placebo. Active treatment consists of nitrendipine (10-40 mg/day), combined with enalapril (5-20 mg/day) and hydrochlorothiazide (12.5-25 mg/day), as necessary. The patients of the control group receive matching placebos. The drugs (or matching placebos) are stepwise titrated and combined in order to reduce systolic blood pressure by 20 mmHg at least to a level below 150 mmHg. Morbidity and mortality are monitored to enable an intention-to-treat and per-protocol comparison of the outcome in the 2 treatment groups.


Eligibility criteria: Inclusion Criteria:

* At least 60 years old.
* Sitting systolic blood pressure on masked placebo, during run-in phase of 160 to 219 mmHg, with a sitting diastolic blood pressure below 95 mmHg and a standing systolic blood pressure of at least 140 mmHg
* Informed consent must be obtained

Exclusion Criteria:

* Systolic hypertension is secondary to a disorder that needed specific medical or surgical treatment.
* Retinal haemorrhage or papilloedema;
* Congestive heart failure
* Dissecting aortic aneurysm
* Serum creatinine concentration at presentation of 180µmol/L or more.
* History of severe nose bleeds.
* Stroke or myocardial infarction in the year before the study.
* Dementia.
* Substance abuse.
* Any disorder prohibiting a sitting or standing position.
* Any severe concomitant cardiovascular or non-cardiovascular disease.

Primary outcomes:
measure: Incidence of stroke
timeFrame: 3-monthly visits up to 5 years
Secondary outcomes:
measure: Death
timeFrame: 3-monthly visits up to 5 years
measure: Myocardial infarction
timeFrame: 3-monthly visits up to 5 years
measure: Congestive heart failure
timeFrame: 3-monthly visits up to 5 years
Other outcomes:
Locations:
Study officials:
affiliation: University of Leuven
name: Jan A Staessen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hara A, Thijs L, Asayama K, Jacobs L, Wang JG, Staessen JA. Randomised double-blind comparison of placebo and active drugs for effects on risks associated with blood pressure variability in the Systolic Hypertension in Europe trial. PLoS One. 2014 Aug 4;9(8):e103169. doi: 10.1371/journal.pone.0103169. eCollection 2014.