Diastolic DysfunctionPhase 4NCT01061450
Simvastatin and Diastolic Dysfunction
A Phase 4 study testing Simvastatin in people with Diastolic Dysfunction and Hypertension, run by Brasilia Heart Study Group at 1 site in Brazil.
Trial summary
Diastolic dysfunction (DD) is an increasingly frequent condition in hypertensive individuals whose treatment remains unclear. Its presence is related to higher morbidity and mortality independent of blood pressure levels. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Diastolic Dysfunction, Hypertension
- What is being tested?
- Simvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2006to Aug 2009
- Phase
- Phase 4
- 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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- men or postmenopausal women aged between 40 and 65 years old
- normal fasting blood glucose (<100 mg/dL) and glucose tolerance test (<140 mg/dL)
- waist circumference < 102 cm (men) or < 88cm (women)
- triglycerides <150 mg/dL, LDL cholesterol ≤ 160 mg/dl
- creatinine <1.2 mg/dL, sinus rhythm
- the presence of grade 1 or 2 of DD with an ejection fraction of left ventricle > 55%
- absence of myocardial ischemia during dobutamine stress echocardiography
Who cannot join
- thyroid dysfunction
- acute or chronic liver disease
- regular use of 3 or more antihypertensive drugs
- secondary hypertension
- symptoms or history of atherosclerotic disease
- valvular dysfunction
- LVH 14 and use of statins in the last 6 months
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto de Cardiologia do Distrito Federal
Brasília, Federal District, 70000.000
About this study
Official title: Effect of the Addition of Simvastatin to Enalapril in Hypertensive Individuals With Average Cholesterol Levels and Diastolic Dysfunction
Diastolic dysfunction (DD) is an increasingly frequent condition in hypertensive individuals whose treatment remains unclear. Its presence is related to higher morbidity and mortality independent of blood pressure levels. The aim of this study is to investigate the additive effect of simvastatin on enalapril on DD in hypertensive patients with average cholesterol levels.
For this aim, hypertensive patients with DD and LDL-cholesterol <160 mg/dL will undergo a run-in phase to achieve a systolic blood pressure (SBP) <135 mmHg and diastolic blood pressure (DBP) <85 mmHg with enalapril. Hydrochlorothiazide could be added when need to achieve SBP or DBP control. Four weeks after reaching the optimum anti-hypertensive regimen patients will be randomized to receive 80 mg simvastatin or placebo for a period of 20 weeks. Echocardiograms will be performed before and after treatment with measurement of left atrial volume, conventional and tissue Doppler velocities in early diastole and late diastole. The evaluation of these will allow to identify changes of DD severity after treatment.
- Conditions
- Diastolic Dysfunction, Hypertension
- Being tested
- Simvastatin, Placebo
- Keywords
- Diastolic dysfunction, hypertension, Statins, ACE inhibitor, Echocardiography
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SimvastatinDrug
Also called Zocor
80 mg once a day
PlaceboDrug
1 pill once a day
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
| Simvastatin | Experimental | Simvastatin 80 mg/day Receives: Drug: Simvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in E/A ratio and e' wave velocity
Measured: 20 weeks
Secondary outcomes (7)
Changes in left atrium volume.
Measured: 20 weeks
Changes in left ventricular mass.
Measured: 20 weeks
Changes in e´/a´ waves ratio.
Measured: 20 weeks
Changes in mitral deceleration time.
Measured: 20 weeks
Changes in the ratio of mitral inflow velocity to annular relaxation velocity.
Measured: 20 weeks
Changes in mitral annulus systolic velocity
Measured: 20 weeks
Diastolic function reserve index measured at peak stress with dobutamine
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2010 (estimated)
- Study startNov 2006
- Primary completionJul 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diastolic DysfunctionStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brasilia Heart Study Group
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo a Pesquisa do Distrito Federal, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Investigators
- Adenalva LS Beck, MD, Principal investigator, InCor Heart InstituteAndrei C Sposito, MD, PhD, Study chair, University of Brasilia Medical School, Brasilia, BrazilMaria E Otto, MD, PhD, Principal investigator, Instituto de Cardiologia do Distrito Federal, Brasilia, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01061450
- Sponsor's protocol ID
- Statin_DD
- Status last verified
- Feb 2010
- First submitted
- 2 Feb 2010
- Last updated
- 3 Feb 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Beck AL, Otto ME, D'Avila LB, Netto FM, Armendaris MK, Sposito AC. Diastolic function parameters are improved by the addition of simvastatin to enalapril-based treatment in hypertensive individuals. Atherosclerosis. 2012 Jun;222(2):444-8. doi: 10.1016/j.atherosclerosis.2012.03.030. Epub 2012 Apr 3.
PubMed 22554359
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Addition of Simvastatin to Enalapril in Hypertensive Individuals With Average Cholesterol Levels and Diastolic Dysfunction
- ClinicalTrials.gov ID
- NCT01061450
- Acronym / sponsor ID
- Statin_DD
- Conditions
- Diastolic Dysfunction, Hypertension
- Keywords
- Diastolic dysfunction, hypertension, Statins, ACE inhibitor, Echocardiography
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Brasilia Heart Study GroupUniversity, hospital or other
- Collaborators
- Fundação de Amparo a Pesquisa do Distrito Federal, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Study start
- Nov 2006
- Primary completion
- Jul 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 3 Feb 2010 (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.
Diastolic dysfunction (DD) is an increasingly frequent condition in hypertensive individuals whose treatment remains unclear. Its presence is related to higher morbidity and mortality independent of blood pressure levels. The aim of this study is to investigate the additive effect of simvastatin on enalapril on DD in hypertensive patients with average cholesterol levels.
For this aim, hypertensive patients with DD and LDL-cholesterol <160 mg/dL will undergo a run-in phase to achieve a systolic blood pressure (SBP) <135 mmHg and diastolic blood pressure (DBP) <85 mmHg with enalapril. Hydrochlorothiazide could be added when need to achieve SBP or DBP control. Four weeks after reaching the optimum anti-hypertensive regimen patients will be randomized to receive 80 mg simvastatin or placebo for a period of 20 weeks. Echocardiograms will be performed before and after treatment with measurement of left atrial volume, conventional and tissue Doppler velocities in early diastole and late diastole. The evaluation of these will allow to identify changes of DD severity after treatment.
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 |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
| Simvastatin | Experimental | Drug: SimvastatinSimvastatin 80 mg/day |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- men or postmenopausal women aged between 40 and 65 years old
- normal fasting blood glucose (<100 mg/dL) and glucose tolerance test (<140 mg/dL)
- waist circumference < 102 cm (men) or < 88cm (women)
- triglycerides <150 mg/dL, LDL cholesterol ≤ 160 mg/dl
- creatinine <1.2 mg/dL, sinus rhythm
Key exclusion criteria (7 listed)
- thyroid dysfunction
- acute or chronic liver disease
- regular use of 3 or more antihypertensive drugs
- secondary hypertension
- symptoms or history of atherosclerotic disease
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 |
|---|---|---|
| SimvastatinAlso: Zocor80 mg once a day | Drug | Simvastatin |
| Placebo1 pill once a day | Drug | Placebo |
Primary outcome
Changes in E/A ratio and e' wave velocity
Time frame: 20 weeks
7 secondary outcomes
Changes in left atrium volume.
Time frame: 20 weeks
Changes in left ventricular mass.
Time frame: 20 weeks
Changes in e´/a´ waves ratio.
Time frame: 20 weeks
Changes in mitral deceleration time.
Time frame: 20 weeks
Changes in the ratio of mitral inflow velocity to annular relaxation velocity.
Time frame: 20 weeks
Changes in mitral annulus systolic velocity
Time frame: 20 weeks
Diastolic function reserve index measured at peak stress with dobutamine
Time frame: 20 weeks
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 3 Feb 2010.
- Derived from this study: PubMed 22554359Beck AL, Otto ME, D'Avila LB, Netto FM, Armendaris MK, Sposito AC. Diastolic function parameters are improved by the addition of simvastatin to enalapril-based treatment in hypertensive individuals. Atherosclerosis. 2012 Jun;222(2):444-8. doi: 10.1016/j.atherosclerosis.2012.03.030. Epub 2012 Apr 3.
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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.
Adenalva LS Beck, MD principal investigator
InCor Heart Institute
Andrei C Sposito, MD, PhD study chair
University of Brasilia Medical School, Brasilia, Brazil
Maria E Otto, MD, PhD principal investigator
Instituto de Cardiologia do Distrito Federal, Brasilia, Brazil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Simvastatin in people with Diastolic Dysfunction and Hypertension, run by Brasilia Heart Study Group at 1 site in Brazil.
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 7 inclusion and 7 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 3 Feb 2010. 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 Brazil. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 in E/A ratio and e' wave velocity (time frame: 20 weeks). 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 NCT01061450, which also lists 1 linked publication.
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 3 Feb 2010.