Primary Arterial HypertensionPhase 3ENESYSNCT00942487
Effects of Nebivolol on Subclinical Left Ventricular dySfunction: A Comparative Study Against Metoprolol
A Phase 3 study testing Nebilet and Corvitol in people with Primary Arterial Hypertension, run by Berlin-Chemie Menarini at 1 site in Romania.
Trial summary
Summary: Study title: Effects of Nebivolol on subclinical left ventricular dysfunction. A comparative study against Metoprolol. (ENESYS study) Study phase: 3 Study design (parallel, cross-over, etc.), randomisation and blinding procedures, type of control (placebo or active): randomised, parallel, active-controlled… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Arterial Hypertension
- What is being tested?
- Nebilet and Corvitol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteRomania
- Study dates
- Apr 2005to Jul 2009
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged 18 years or older, men and women, hospitalized and outpatients
- with a history of primary arterial hypertension
- with a daytime ambulatory blood pressure >140 and/or >90 mm Hg
- with left ventricular hypertrophy: LVMI > 125 g/m2 for men, and > 110 g/m2 for women, by Devereux formula, as recommended by the ESH-ESC guidelines (14)
- in sinus rhythm
- consented, by signing the Informed Consent
Who cannot join
- Severe arterial hypertension (systolic blood pressure > 180 mm Hg and/or diastolic blood pressure > 110 mm Hg)
- Any history of coronary heart disease (stable angina, acute coronary syndromes, myocardial infarction)
- Any history of cerebrovascular disease
- Renal impairment (creatinine > 1.5 mg% for men, > 1.4 mg% for women)
- Left ventricular global systolic dysfunction (EF < 45%)
- More than mild valvar (mitral or aortic) regurgitation
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- Hypertrophic cardiomyopathy
- Pericarditis
- Cor pulmonale
- Pregnancy or lactating women
- Any significant co-morbidities
- Contraindication to beta-blocker therapy
- Concomitant treatment with other beta-blockers
- Participation to another investigational study in the last 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of NEbivolol on Subclinical Left Ventricular dYSfunction. A Comparative Study Against Metoprolol. The ENESYS Study. A Phase 3, Randomised, Parallel, Active-controlled, Open Label Study
Summary:
- Study title: Effects of Nebivolol on subclinical left ventricular dysfunction. A comparative study against Metoprolol. (ENESYS study)
- Study phase: 3
- Study design (parallel, cross-over, etc.), randomisation and blinding procedures, type of control (placebo or active): randomised, parallel, active-controlled, open label
- Study treatment(s)/drug(s): Nebivolol versus Metoprolol
- Patients:
- characteristics: patients with hypertension and left ventricular hypertrophy
- planned total number: 50
- Study duration:
- total enrolment period (months): 18
- treatment period (months): 6
- follow up period (months): 6
- Total study duration (months): 24
- Number of Centres: 1
- Country(ies): Romania (RO)
Read the detailed description
STUDY OBJECTIVES
- PRIMARY:
- Longitudinal myocardial velocities at rest (assessed by tissue Doppler echocardiography)
- Systolic functional reserve (calculated as the absolute and relative increase of the myocardial systolic velocities at peak stress from rest)
- Brain natriuretic peptide (BNP, NT-pro BNP) after a 6-months period of treatment with nebivolol versus metoprolol. An improvement of more than 20% of the myocardial resting velocities of systolic functional reserve is considered to be clinically relevant. The working hypothesis is that the improvement of subclinical left ventricular dysfunction after 6 months of treatment is going to be greater in patients who receive nebivolol than in those who receive metoprolol.
- SECONDARY:
- Global systolic function (ejection fraction)
- Radial myocardial velocities
- Right ventricular function
- Global diastolic function
- Left ventricular mass index
- Conditions
- Primary Arterial Hypertension
- Being tested
- Nebilet, Corvitol
- Keywords
- arterial hypertension
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NebiletDrug
Trade-mark: Nebilet® (Berlin-Chemie Menarini) INN: nebivolol Dosage and route of administration: 5 mg tablets, o.d. for oral administration
CorvitolDrug
Trade-mark: Corvitol (Berlin-Chemie Menarini) INN: metoprolol Dosage and route of administration: 50 mg tablets, b.d. (100 mg/day) for oral administration
| Study group | Role | What they receive |
|---|---|---|
| Nebivolol | Experimental | Not described Receives: Drug: Nebilet |
| Metoprolol | Active comparator | Not described Receives: Drug: Corvitol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of: longitudinal myocardial velocities at rest (assessed by TDE), systolic functional reserve (calculated as the absolute and relative increase of the myocardial systolic velocities at peak stress from rest), NT-proBNP
Measured: 6 months
Secondary outcomes (5)
Global systolic function (ejection fraction)
Measured: 6 months
Radial myocardial velocities
Measured: 6 months
Right ventricular function
Measured: 6 months
Global diastolic function
Measured: 6 months
Left ventricular mass index
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2009 (estimated)
- Study startApr 2005
- Primary completionDec 2008
- Study completionJul 2009
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 Primary Arterial HypertensionStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Berlin-Chemie Menarini
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Dragos VINEREANU, MD, Principal investigator, University and Emergency Hospital Bucharest, Romania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00942487
- Sponsor's protocol ID
- MeRo/04/Neb-LVD/003
- Acronym
- ENESYS
- Status last verified
- Jul 2009
- First submitted
- 19 Jul 2009
- Last updated
- 21 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Vinereanu D, Madler CF, Gherghinescu C, Ciobanu AO, Fraser AG. Cumulative impact of cardiovascular risk factors on regional left ventricular function and reserve: progressive long-axis dysfunction with compensatory radial changes. Echocardiography. 2011 Sep;28(8):813-20. doi: 10.1111/j.1540-8175.2011.01456.x. Epub 2011 Aug 9.
PubMed 21827541Vinereanu D, Gherghinescu C, Ciobanu AO, Magda S, Niculescu N, Dulgheru R, Dragoi R, Lautaru A, Cinteza M, Fraser AG. Reversal of subclinical left ventricular dysfunction by antihypertensive treatment: a prospective trial of nebivolol against metoprolol. J Hypertens. 2011 Apr;29(4):809-17. doi: 10.1097/HJH.0b013e3283442f37.
PubMed 21297499
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of NEbivolol on Subclinical Left Ventricular dYSfunction. A Comparative Study Against Metoprolol. The ENESYS Study. A Phase 3, Randomised, Parallel, Active-controlled, Open Label Study
- ClinicalTrials.gov ID
- NCT00942487
- Acronym / sponsor ID
- ENESYS / MeRo/04/Neb-LVD/003
- Conditions
- Primary Arterial Hypertension
- Keywords
- arterial hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Berlin-Chemie MenariniIndustry (pharma, biotech, devices)
- Study start
- Apr 2005
- Primary completion
- Dec 2008 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 21 Jul 2009 (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.
Summary:
- Study title: Effects of Nebivolol on subclinical left ventricular dysfunction. A comparative study against Metoprolol. (ENESYS study)
- Study phase: 3
- Study design (parallel, cross-over, etc.), randomisation and blinding procedures, type of control (placebo or active): randomised, parallel, active-controlled, open label
- Study treatment(s)/drug(s): Nebivolol versus Metoprolol
- Patients:
- characteristics: patients with hypertension and left ventricular hypertrophy
- planned total number: 50
- Study duration:
- total enrolment period (months): 18
- treatment period (months): 6
- follow up period (months): 6
- Total study duration (months): 24
- Number of Centres: 1
- Country(ies): Romania (RO)
Detailed description
STUDY OBJECTIVES
- PRIMARY:
- Longitudinal myocardial velocities at rest (assessed by tissue Doppler echocardiography)
- Systolic functional reserve (calculated as the absolute and relative increase of the myocardial systolic velocities at peak stress from rest)
- Brain natriuretic peptide (BNP, NT-pro BNP) after a 6-months period of treatment with nebivolol versus metoprolol. An improvement of more than 20% of the myocardial resting velocities of systolic functional reserve is considered to be clinically relevant. The working hypothesis is that the improvement of subclinical left ventricular dysfunction after 6 months of treatment is going to be greater in patients who receive nebivolol than in those who receive metoprolol.
- SECONDARY:
- Global systolic function (ejection fraction)
- Radial myocardial velocities
- Right ventricular function
- Global diastolic function
- Left ventricular mass index
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nebivolol | Experimental | Drug: Nebilet |
| Metoprolol | Active comparator | Drug: Corvitol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- aged 18 years or older, men and women, hospitalized and outpatients
- with a history of primary arterial hypertension
- with a daytime ambulatory blood pressure >140 and/or >90 mm Hg
- with left ventricular hypertrophy: LVMI > 125 g/m2 for men, and > 110 g/m2 for women, by Devereux formula, as recommended by the ESH-ESC guidelines (14)
- in sinus rhythm
Key exclusion criteria (14 listed)
- Severe arterial hypertension (systolic blood pressure > 180 mm Hg and/or diastolic blood pressure > 110 mm Hg)
- Any history of coronary heart disease (stable angina, acute coronary syndromes, myocardial infarction)
- Any history of cerebrovascular disease
- Renal impairment (creatinine > 1.5 mg% for men, > 1.4 mg% for women)
- Left ventricular global systolic dysfunction (EF < 45%)
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 |
|---|---|---|
| NebiletTrade-mark: Nebilet® (Berlin-Chemie Menarini) INN: nebivolol Dosage and route of administration: 5 mg tablets, o.d. for oral administration | Drug | Nebivolol |
| CorvitolTrade-mark: Corvitol (Berlin-Chemie Menarini) INN: metoprolol Dosage and route of administration: 50 mg tablets, b.d. (100 mg/day) for oral administration | Drug | Metoprolol |
Primary outcome
Changes of: longitudinal myocardial velocities at rest (assessed by TDE), systolic functional reserve (calculated as the absolute and relative increase of the myocardial systolic velocities at peak stress from rest), NT-proBNP
Time frame: 6 months
5 secondary outcomes
Global systolic function (ejection fraction)
Time frame: 6 months
Radial myocardial velocities
Time frame: 6 months
Right ventricular function
Time frame: 6 months
Global diastolic function
Time frame: 6 months
Left ventricular mass index
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2009.
- Derived from this study: PubMed 21827541Vinereanu D, Madler CF, Gherghinescu C, Ciobanu AO, Fraser AG. Cumulative impact of cardiovascular risk factors on regional left ventricular function and reserve: progressive long-axis dysfunction with compensatory radial changes. Echocardiography. 2011 Sep;28(8):813-20. doi: 10.1111/j.1540-8175.2011.01456.x. Epub 2011 Aug 9.
- Derived from this study: PubMed 21297499Vinereanu D, Gherghinescu C, Ciobanu AO, Magda S, Niculescu N, Dulgheru R, Dragoi R, Lautaru A, Cinteza M, Fraser AG. Reversal of subclinical left ventricular dysfunction by antihypertensive treatment: a prospective trial of nebivolol against metoprolol. J Hypertens. 2011 Apr;29(4):809-17. doi: 10.1097/HJH.0b013e3283442f37.
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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.
Dragos VINEREANU, MD principal investigator
University and Emergency Hospital Bucharest, Romania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nebilet and Corvitol in people with Primary Arterial Hypertension, run by Berlin-Chemie Menarini at 1 site in Romania.
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 6 inclusion and 14 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: finished, as of the sponsor's last update on 21 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes of: longitudinal myocardial velocities at rest (assessed by TDE), systolic functional reserve (calculated as the absolute and relative increase of the myocardial systolic velocities at peak stress from rest), NT-proBNP (time frame: 6 months). 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 NCT00942487, 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 21 Jul 2009.