Isolated Systolic HypertensionPhase 2Syst-EurNCT02088450
Systolic Hypertension in Europe Placebo-Controlled Trial
A Phase 2 study testing Active treatment with nitrendipine (10-40 mg/day). in people with Isolated Systolic Hypertension, run by KU Leuven.
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Isolated Systolic Hypertension
- What is being tested?
- Active treatment with nitrendipine (10-40 mg/day).
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4,695 participants
- Where
- No sites listed yet
- Study dates
- Feb 1990to Feb 1997
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
About this study
Official title: Systolic Hypertension in Europe Trial
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
- Being tested
- Active treatment with nitrendipine (10-40 mg/day).
- Keywords
- Cardiovascular complications, Clinical trial, Elderly, Isolated systolic hypertension, Stroke
- Medical subject headings
- Isolated Systolic Hypertension, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Active treatment with nitrendipine (10-40 mg/day). |
| Placebo | Placebo comparator | Placebo tablets were identical to the study drugs with a similar schedule. Receives: Drug: Active treatment with nitrendipine (10-40 mg/day). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of stroke
Available in Lancet 1997; 350:757-764
Measured: 3-monthly visits up to 5 years
Secondary outcomes (3)
Death
Available in Lancet 1997; 350:757-764
Measured: 3-monthly visits up to 5 years
Myocardial infarction
Available in Lancet 1997; 350:757-764
Measured: 3-monthly visits up to 5 years
Congestive heart failure
Available in Lancet 1997; 350:757-764
Measured: 3-monthly visits up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2014 (estimated)
- Study startFeb 1990
- Primary completionFeb 1997
- Study completionFeb 1997
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Isolated Systolic HypertensionStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 4,695 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jan A. Staessen, KU Leuven
- Investigators
- Jan A Staessen, MD, PhD, Principal investigator, University of Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02088450
- Sponsor's protocol ID
- Syst-Eur
- Acronym
- Syst-Eur
- Status last verified
- May 2017
- First submitted
- 10 Mar 2014
- Last updated
- 11 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Syst-Eur data are available on request by other investigators, whose research is ethically approved.
Publications
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.
PubMed 36744469Hara 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.
PubMed 25090617
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systolic Hypertension in Europe Trial
- ClinicalTrials.gov ID
- NCT02088450
- Acronym / sponsor ID
- Syst-Eur / Syst-Eur
- Conditions
- Isolated Systolic Hypertension
- Keywords
- Cardiovascular complications, Clinical trial, Elderly, Isolated systolic hypertension, Stroke
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 4,695 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- Feb 1990
- Primary completion
- Feb 1997 (actual)
- Study completion
- Feb 1997 (actual)
- First posted
- 17 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active treatment | Active comparator | Drug: Active treatment with nitrendipine (10-40 mg/day).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 | Placebo comparator | Drug: Active treatment with nitrendipine (10-40 mg/day).Placebo tablets were identical to the study drugs with a similar schedule. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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, Placebo |
Primary outcome
Incidence of stroke
Time frame: 3-monthly visits up to 5 years
Available in Lancet 1997; 350:757-764
3 secondary outcomes
Death
Time frame: 3-monthly visits up to 5 years
Myocardial infarction
Time frame: 3-monthly visits up to 5 years
Congestive heart failure
Time frame: 3-monthly visits up to 5 years
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2017.
- Derived from this study: PubMed 36744469Grobman 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.
- Derived from this study: PubMed 25090617Hara 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.
- Individual participant dataSharing planned: Yes. Syst-Eur data are available on request by other investigators, whose research is ethically approved.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan A Staessen, MD, PhD principal investigator
University of Leuven
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Active treatment with nitrendipine (10-40 mg/day). in people with Isolated Systolic Hypertension, run by KU Leuven.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of stroke (time frame: 3-monthly visits up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02088450, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2017.