Systolic Hypertension in Europe Placebo-Controlled Trial

Isolated Systolic Hypertension Clinical Trial

— Syst-Eur  

Official title:

Systolic Hypertension in Europe Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02088450
• Other study ID #: Syst-Eur
• Status: Terminated
• Phase: Phase 2
• First received: March 10, 2014
• Last updated: May 10, 2017
• Start date: February 1990
• Est. completion date: February 1997

Study information

• Verified date: May 2017
• Source: Katholieke Universiteit Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4695
• Est. completion date: February 1997
• Est. primary completion date: February 1997
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension
• Isolated Systolic Hypertension

Intervention

Drug:
• Active treatment with nitrendipine (10-40 mg/day).
If necessary, the dihydropyridine calcium-channel blocker was combined with or replaced by enalapril maleate (5-20 mg/day), hydrochlorothiazide (12.5-25 mg/day), or both drugs.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Katholieke Universiteit Leuven

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of stroke	Available in Lancet 1997; 350:757-764	3-monthly visits up to 5 years
Secondary	Death	Available in Lancet 1997; 350:757-764	3-monthly visits up to 5 years
Secondary	Myocardial infarction	Available in Lancet 1997; 350:757-764	3-monthly visits up to 5 years
Secondary	Congestive heart failure	Available in Lancet 1997; 350:757-764	3-monthly visits up to 5 years