High Blood PressureIMPULSIONNCT00416611
IMPlementation of gUideLines for the Management of Arterial hypertenSION. The IMPULSION Study
An observational study of High Blood Pressure, run by Hellenic Atherosclerosis Society at 1 site in Greece.
Trial summary
The objective of this protocol is to improve awareness, treatment, and control of arterial hypertension, within primary prevention of target organ damage, by implementing guidelines, after training of the participating physicians. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- High Blood Pressure
- What is being tested?
- Implementation of guidelines
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,000 participants
- Where
- 1 siteGreece
- Study dates
- Nov 2006to Nov 2007
- Phase
- Observational
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Arterial hypertension as defined by the JNC 7 report
Who cannot join
- Pregnancy
- Lactation
- Malignancies with small life expectancy
- Unwillingness to participate
Trial locations and contacts
1 site in 1 country.
Greece1 site
Hellenic Atherosclerosis Society
Thessaloniki, Thessaloniki, 55132
About this study
The objective of this protocol is to improve awareness, treatment, and control of arterial hypertension, within primary prevention of target organ damage, by implementing guidelines, after training of the participating physicians.
Read the detailed description
Physicians from 20 hospitals and 40 health centres (primary health care settings) were trained to implement guidelines in treating arterial hypertension.
There will be a baseline recording of patients with arterial hypertension and then physicians will have to complete a one page form (by ticking pre-specified boxes) about the baseline status of the patients and will have to report the measures they took to improve awareness, treatment, and effective control of arterial hypertension. After a six month effort, physicians will have to complete the same form at study completion. Previous training of physicians and the fact that they will have to report their success in treating hypertension will hopefully contribute to an increase in number of hypertensive patients at blood pressure target, and will minimise the target organ damage. The estimated reduction in coronary heart disease risk will be evaluated by a comparison of this risk (as evaluated by a risk engine, i.e. PROCAM) at study completion with that of baseline.
- Conditions
- High Blood Pressure
- Being tested
- Implementation of guidelines
- Keywords
- High blood pressure, Awareness, Treatment, Effective Control, Coronary heart disease risk reduction, Hypertension
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implementation of guidelinesBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy in arterial hypertension control
Measured: 6 months
Efficacy in reducing estimated risk of coronary heart disease
Measured: 6 months
Secondary outcomes (2)
Cost effectiveness of arterial hypertension control
Measured: 6 months
Differences between primary and secondary health care settings as well as teaching hospitals
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 posted28 Dec 2006 (estimated)
- Study startNov 2006
- Primary completionNov 2007
- Study completionNov 2007
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 High Blood PressureStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hellenic Atherosclerosis Society
- Sponsor type
- University, hospital or other
- Investigators
- Athyros G Athyros, MD, Study director, Clinical Trials Chair of Hellenic Atherosclerosis Society
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00416611
- Sponsor's protocol ID
- HAS-02-231206
- Acronym
- IMPULSION
- Status last verified
- Jan 2009
- First submitted
- 23 Dec 2006
- Last updated
- 29 Jan 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Karagiannis A, Athyros VG, Papageorgiou A, Tziomalos K, Elisaf M. Should atenolol still be recommended as first-line therapy for primary hypertension? Hellenic J Cardiol. 2006 Sep-Oct;47(5):298-307. No abstract available.
PubMed 17134065Karagiannis A, Hatzitolios AI, Athyros VG, Deligianni K, Charalambous C, Papathanakis C, Theodosiou G, Drakidis T, Chatzikaloudi V, Kamilali C, Matsiras S, Matziris A, Savopoulos C, Baltatzi M, Rudolf J, Tziomalos K, Mikhailidis DP. Implementation of guidelines for the management of arterial hypertension. The impulsion study. Open Cardiovasc Med J. 2009 May 5;3:26-34. doi: 10.2174/1874192400903010026.
PubMed 19557149
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IMPlementation of gUideLines for the Management of Arterial hypertenSION. The IMPULSION Study
- ClinicalTrials.gov ID
- NCT00416611
- Acronym / sponsor ID
- IMPULSION / HAS-02-231206
- Conditions
- High Blood Pressure
- Keywords
- High blood pressure, Awareness, Treatment, Effective Control, Coronary heart disease risk reduction, Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Hellenic Atherosclerosis SocietyUniversity, hospital or other
- Study start
- Nov 2006
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 28 Dec 2006 (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 objective of this protocol is to improve awareness, treatment, and control of arterial hypertension, within primary prevention of target organ damage, by implementing guidelines, after training of the participating physicians.
Detailed description
Physicians from 20 hospitals and 40 health centres (primary health care settings) were trained to implement guidelines in treating arterial hypertension.
There will be a baseline recording of patients with arterial hypertension and then physicians will have to complete a one page form (by ticking pre-specified boxes) about the baseline status of the patients and will have to report the measures they took to improve awareness, treatment, and effective control of arterial hypertension. After a six month effort, physicians will have to complete the same form at study completion. Previous training of physicians and the fact that they will have to report their success in treating hypertension will hopefully contribute to an increase in number of hypertensive patients at blood pressure target, and will minimise the target organ damage. The estimated reduction in coronary heart disease risk will be evaluated by a comparison of this risk (as evaluated by a risk engine, i.e. PROCAM) at study completion with that of baseline.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Arterial hypertension as defined by the JNC 7 report
Key exclusion criteria (4 listed)
- Pregnancy
- Lactation
- Malignancies with small life expectancy
- Unwillingness to participate
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 |
|---|---|---|
| Implementation of guidelines | Behavioural | – |
Primary outcome
Efficacy in arterial hypertension control
Time frame: 6 months
Efficacy in reducing estimated risk of coronary heart disease
Time frame: 6 months
2 secondary outcomes
Cost effectiveness of arterial hypertension control
Time frame: 6 months
Differences between primary and secondary health care settings as well as teaching hospitals
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 29 Jan 2009.
- Results publication: PubMed 17134065Karagiannis A, Athyros VG, Papageorgiou A, Tziomalos K, Elisaf M. Should atenolol still be recommended as first-line therapy for primary hypertension? Hellenic J Cardiol. 2006 Sep-Oct;47(5):298-307. No abstract available.
- Derived from this study: PubMed 19557149Karagiannis A, Hatzitolios AI, Athyros VG, Deligianni K, Charalambous C, Papathanakis C, Theodosiou G, Drakidis T, Chatzikaloudi V, Kamilali C, Matsiras S, Matziris A, Savopoulos C, Baltatzi M, Rudolf J, Tziomalos K, Mikhailidis DP. Implementation of guidelines for the management of arterial hypertension. The impulsion study. Open Cardiovasc Med J. 2009 May 5;3:26-34. doi: 10.2174/1874192400903010026.
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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.
Athyros G Athyros, MD study director
Clinical Trials Chair of Hellenic Atherosclerosis Society
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of High Blood Pressure, run by Hellenic Atherosclerosis Society at 1 site in Greece.
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 1 inclusion and 4 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 29 Jan 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 Greece. 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.
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?
Efficacy in arterial hypertension control (time frame: 6 months). The study lists 2 primary outcomes in all. 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 NCT00416611, 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 29 Jan 2009.