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Systolic Hypertension in Europe Placebo-Controlled Trial (Syst-Eur)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02088450
Recruitment Status : Terminated
First Posted : March 17, 2014
Last Update Posted : May 11, 2017
Sponsor:
Information provided by (Responsible Party):
Jan A. Staessen, KU Leuven

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.

Condition or disease Intervention/treatment Phase
Isolated Systolic Hypertension Drug: Active treatment with nitrendipine (10-40 mg/day). Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4695 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Systolic Hypertension in Europe Trial
Study Start Date : February 1990
Actual Primary Completion Date : February 1997
Actual Study Completion Date : February 1997

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Active treatment
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.
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.

Placebo Comparator: Placebo
Placebo tablets were identical to the study drugs with a similar schedule.
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.




Primary Outcome Measures :
  1. Incidence of stroke [ Time Frame: 3-monthly visits up to 5 years ]
    Available in Lancet 1997; 350:757-764


Secondary Outcome Measures :
  1. Death [ Time Frame: 3-monthly visits up to 5 years ]
    Available in Lancet 1997; 350:757-764

  2. Myocardial infarction [ Time Frame: 3-monthly visits up to 5 years ]
    Available in Lancet 1997; 350:757-764

  3. Congestive heart failure [ Time Frame: 3-monthly visits up to 5 years ]
    Available in Lancet 1997; 350:757-764



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02088450


Sponsors and Collaborators
KU Leuven
Investigators
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Principal Investigator: Jan A Staessen, MD, PhD University of Leuven

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jan A. Staessen, Professor of Medicine, KU Leuven
ClinicalTrials.gov Identifier: NCT02088450    
Other Study ID Numbers: Syst-Eur
First Posted: March 17, 2014    Key Record Dates
Last Update Posted: May 11, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Syst-Eur data are available on request by other investigators, whose research is ethically approved.
Keywords provided by Jan A. Staessen, KU Leuven:
Cardiovascular complications
Clinical trial
Elderly
Isolated systolic hypertension
Stroke
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Nitrendipine
Calcium Channel Blockers
Antihypertensive Agents
Physiological Effects of Drugs
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Vasodilator Agents