Systolic Hypertension in Europe Placebo-Controlled Trial

NCT02088450 | Terminated Phase 2 DMC

• 1 other identifier: Syst-Eur
• Study Type: interventional
• Target: 4,695
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Isolated Systolic Hypertension

Keywords

Cardiovascular complications; Clinical trial; Elderly; Isolated systolic hypertension; Stroke

Outcome Measures

Primary Outcomes (1)

• Incidence of stroke

  Available in Lancet 1997; 350:757-764

  3-monthly visits up to 5 years

Secondary Outcomes (3)

• Death

  3-monthly visits up to 5 years

• Myocardial infarction

  3-monthly visits up to 5 years

• Congestive heart failure

  3-monthly visits up to 5 years

Study Arms (2)

Active treatment

ACTIVE COMPARATOR

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).

Placebo

PLACEBO COMPARATOR

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

Drug: Active treatment with nitrendipine (10-40 mg/day).

Interventions

Active treatment with nitrendipine (10-40 mg/day). DRUG

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.

Active treatment; Placebo

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• KU Leuven: lead

Related Publications (2)

• Grobman B, Turkson-Ocran RN, Staessen JA, Yu YL, Lipsitz LA, Mukamal KJ, Juraschek SP. Body Position and Orthostatic Hypotension in Hypertensive Adults: Results from the Syst-Eur Trial. Hypertension. 2023 Apr;80(4):820-827. doi: 10.1161/HYPERTENSIONAHA.122.20602. Epub 2023 Feb 6.

  PMID: 36744469 DERIVED

• 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.

  PMID: 25090617 DERIVED

MeSH Terms

Conditions

Isolated Systolic Hypertension; Stroke

Interventions

Nitrendipine

Condition Hierarchy (Ancestors)

Essential Hypertension; Hypertension; Vascular Diseases; Cardiovascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Jan A Staessen, MD, PhD

  University of Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: March 10, 2014
• First Posted: March 17, 2014
• Study Start: February 1, 1990
• Primary Completion: February 1, 1997
• Study Completion: February 1, 1997
• Last Updated: May 11, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will share