HypertensionNCT02148991
Clinical Trial in Patients With Hypertension and Left Ventricular Dysfunction
An observational study of Hypertension and Cardiac Arrhythmias, run by Elpen Pharmaceutical Co. Inc. at 2 sites in Greece.
Trial summary
Arterial hypertension causes adverse effects on the entire cardiovascular system, with effects centrally such as diastolic dysfunction and structural changes of the left ventricle and, peripherally such as endothelial dysfunction and increased thickness of the vessels. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Hypertension, Cardiac Arrhythmias, Diabetes Mellitus
- How many people
- 100 participants
- Where
- 2 sitesGreece
- Study dates
- Jul 2014to Jan 2017
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will recruit 100 patients with hypertension.
Who may be able to join
- Age > 18 years
- Men and Women
- Patients with hypertension
- Patients with preserved left ventricular ejection fraction
- Patients on monotherapy with irbesartan
- Patients who have not achieved the therapeutic target regulating AP.
Who cannot join
- Patients with systolic left ventricular dysfunction
- Patients with with severe mitral or aortic valve disease
- Patients with acute coronary or acute aortic syndrome
- Patients with febrile infectious disease
Trial locations and contacts
2 sites in 1 country.
Greece2 sites
Georgios Gennimatas General State Hospital
Athens, Holargos, 11527
Georgios Gennimatas General State Hospital
Athens, 10682
About this study
Official title: Observational Clinical Trial to Assess Irbesartan Alone or in Combination With Amlodipine and Carvedilol Effectiveness in Patients With Hypertension and Left Ventricular Dysfunction
Arterial hypertension causes adverse effects on the entire cardiovascular system, with effects centrally such as diastolic dysfunction and structural changes of the left ventricle and, peripherally such as endothelial dysfunction and increased thickness of the vessels.
Co-existing diseases, such as diabetes mellitus, renal dysfunction, sleep apnea, etc. further aggravate the prognosis of these patients.
Read more
In addition the rate of patients aged > 65 years suffering from un-diagnosed or diagnosed arterial hypertension was 78% for women and 64% for male patients. This population consists from elderly or very elderly patients (over 65 and 80 years respectively) who exhibit more comorbidities and probably less compliance with antihypertensive therapy. Finally, at every age the disease and its effects can affect the quality of life of patients.
The main purpose of this study is to investigate the efficacy of antihypertensive therapy (irbesartan alone or in combination with amplodipine and carvedilol) on the cardiovascular system (diastolic left ventricular function, the function of the endothelium (FMD) and the thickness of the common carotid artery).
The secondary objective of the study is to monitor the quality of life (Quality of Life - QoL) of patients.
Additionally the investigators will seek the correlation of results with co-morbidities, compliance, and patient age.
Read the detailed description
The scope of this entire study is to examine the patients as follows::
Complete Echocardiographic Study including the index of left ventricular mass and relative wall thickness (RWT), measurement acquired from left parasternal longitudinal axis.
Further assessment will be diastolic function and filling pressures of the left ventricle using all indices of diastolic function that can be applied in patients with preserved ejection fraction according to the relevant guidelines of the European Society of Cardiology .
This will include the tissue velocities of the mitral annulus (lateral, septal and average) and the ratio of early diastolic transmitral speed to early diastolic mitral annulus velocity.
The flow of the right upper pulmonary vein , will be recorded during the reverse wave. The flow in pulmonary veins (average of 3 different measurements) will be recorded additionally. The transmitral A wave duration will also be measured, with the Pulsed Doppler sample volume placed at the level of the mitral annulus (average of 3 different measures). The time difference between the Ar-A (reverse pulmonary venous - transmitral flow A wave) will be calculated .
The percentage change of E/A ratio with Valsalva will only be calculated in those patients who perform a substantial Valsalva manoeuvre, as an absolute decrease of E wave at least 20 cm / s.
Left atrial volume index (LAVI) and right ventricular systolic pressure (RVSP) will also be estimated.
Besides left ventricular diastolic function and filling pressures, investigators will also estimate the diameter of the ascending aorta and aortic arch (absolute values and indexed for body surface area).
The study of the endothelial function will be done by the method of flow-mediated dilatation of the right brachial artery by estimating the FMD.
Intima-media thickness of common carotic arteries will also be performed.
Quality of life and level of emotional stress- depression will be assessed with the use of specific questionnaires (EQ-5D questionnaires, Short Form 36 health survey questionnaire (SF-36), Beck Depression Inventory (BDI)).
Patient compliance with antihypertensive treatment will be assessed with the following questionnaires : Brief Medication Questionnaire 1 (BDQ1), Morisky 8-item Medication Adherence Questionnaire.
Additional evaluations will assess co-morbidities in each patient, taking a detailed medical history during the initial diagnostic examination (obstructive sleep apnea , diabetes and glycosylated hemoglobin calculation HbA1 , renal impairment by calculating creatinine clearance , etc.)
After 'three months' follow-up investigators will evaluate the efficacy of therapy in the regulation of hypertension for all patients. Baseline evaluations will be repeated at three months
- complete echocardiographic assessment
- diastolic left ventricular dysfunction
- patients compliance with treatment. Investigators will seek correlations with co-morbidities and patient's age.
- diastolic left ventricular dysfunction
- RWT,
- Left ventricular mass index,
- LAVI, RVSP,
- Ascending Aorta,
- Aortic Arch,
- FMD,
- IMT,
- QoL,
- emotional stress,
- compliance between the two groups, and will seek correlations with co-morbidities and patient age.
- Medical subject headings
- Hypertension, Arrhythmias, Cardiac, Diabetes Mellitus, Renal Insufficiency, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Irbesartan | Patients on irbesartan treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure measurement
Irbesartan effectiveness in diastolic left ventricular function, the function of the endothelium (FMD) and the thickness of the common carotid artery (IMT).
Measured: 3 months
Secondary outcomes (1)
Quality of Life questionnaire rating
Irbesartan effectiveness in hypertensive patients' Quality of Life
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2014 (estimated)
- Study startJul 2014
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elpen Pharmaceutical Co. Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02148991
- Sponsor's protocol ID
- KAR-IIS-2014
- Status last verified
- Apr 2017
- First submitted
- 21 May 2014
- Last updated
- 1 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Clinical Trial to Assess Irbesartan Alone or in Combination With Amlodipine and Carvedilol Effectiveness in Patients With Hypertension and Left Ventricular Dysfunction
- ClinicalTrials.gov ID
- NCT02148991
- Acronym / sponsor ID
- KAR-IIS-2014
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Elpen Pharmaceutical Co. Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2014 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 29 May 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.
Arterial hypertension causes adverse effects on the entire cardiovascular system, with effects centrally such as diastolic dysfunction and structural changes of the left ventricle and, peripherally such as endothelial dysfunction and increased thickness of the vessels.
Co-existing diseases, such as diabetes mellitus, renal dysfunction, sleep apnea, etc. further aggravate the prognosis of these patients.
In addition the rate of patients aged > 65 years suffering from un-diagnosed or diagnosed arterial hypertension was 78% for women and 64% for male patients. This population consists from elderly or very elderly patients (over 65 and 80 years respectively) who exhibit more comorbidities and probably less compliance with antihypertensive therapy. Finally, at every age the disease and its effects can affect the quality of life of patients.
The main purpose of this study is to investigate the efficacy of antihypertensive therapy (irbesartan alone or in combination with amplodipine and carvedilol) on the cardiovascular system (diastolic left ventricular function, the function of the endothelium (FMD) and the thickness of the common carotid artery).
The secondary objective of the study is to monitor the quality of life (Quality of Life - QoL) of patients.
Additionally the investigators will seek the correlation of results with co-morbidities, compliance, and patient age.
Detailed description
The scope of this entire study is to examine the patients as follows::
Complete Echocardiographic Study including the index of left ventricular mass and relative wall thickness (RWT), measurement acquired from left parasternal longitudinal axis.
Further assessment will be diastolic function and filling pressures of the left ventricle using all indices of diastolic function that can be applied in patients with preserved ejection fraction according to the relevant guidelines of the European Society of Cardiology .
This will include the tissue velocities of the mitral annulus (lateral, septal and average) and the ratio of early diastolic transmitral speed to early diastolic mitral annulus velocity.
The flow of the right upper pulmonary vein , will be recorded during the reverse wave. The flow in pulmonary veins (average of 3 different measurements) will be recorded additionally. The transmitral A wave duration will also be measured, with the Pulsed Doppler sample volume placed at the level of the mitral annulus (average of 3 different measures). The time difference between the Ar-A (reverse pulmonary venous - transmitral flow A wave) will be calculated .
The percentage change of E/A ratio with Valsalva will only be calculated in those patients who perform a substantial Valsalva manoeuvre, as an absolute decrease of E wave at least 20 cm / s.
Left atrial volume index (LAVI) and right ventricular systolic pressure (RVSP) will also be estimated.
Besides left ventricular diastolic function and filling pressures, investigators will also estimate the diameter of the ascending aorta and aortic arch (absolute values and indexed for body surface area).
The study of the endothelial function will be done by the method of flow-mediated dilatation of the right brachial artery by estimating the FMD.
Intima-media thickness of common carotic arteries will also be performed.
Quality of life and level of emotional stress- depression will be assessed with the use of specific questionnaires (EQ-5D questionnaires, Short Form 36 health survey questionnaire (SF-36), Beck Depression Inventory (BDI)).
Patient compliance with antihypertensive treatment will be assessed with the following questionnaires : Brief Medication Questionnaire 1 (BDQ1), Morisky 8-item Medication Adherence Questionnaire.
Additional evaluations will assess co-morbidities in each patient, taking a detailed medical history during the initial diagnostic examination (obstructive sleep apnea , diabetes and glycosylated hemoglobin calculation HbA1 , renal impairment by calculating creatinine clearance , etc.)
After 'three months' follow-up investigators will evaluate the efficacy of therapy in the regulation of hypertension for all patients. Baseline evaluations will be repeated at three months
- complete echocardiographic assessment
- diastolic left ventricular dysfunction
- patients compliance with treatment. Investigators will seek correlations with co-morbidities and patient's age.
- diastolic left ventricular dysfunction
- RWT,
- Left ventricular mass index,
- LAVI, RVSP,
- Ascending Aorta,
- Aortic Arch,
- FMD,
- IMT,
- QoL,
- emotional stress,
- compliance between the two groups, and will seek correlations with co-morbidities and patient age.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Irbesartan | – | –Patients on irbesartan treatment |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will recruit 100 patients with hypertension.
Key inclusion criteria (6 listed)
- Age > 18 years
- Men and Women
- Patients with hypertension
- Patients with preserved left ventricular ejection fraction
- Patients on monotherapy with irbesartan
Key exclusion criteria (4 listed)
- Patients with systolic left ventricular dysfunction
- Patients with with severe mitral or aortic valve disease
- Patients with acute coronary or acute aortic syndrome
- Patients with febrile infectious disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Blood pressure measurement
Time frame: 3 months
Irbesartan effectiveness in diastolic left ventricular function, the function of the endothelium (FMD) and the thickness of the common carotid artery (IMT).
1 secondary outcome
Quality of Life questionnaire rating
Time frame: 3 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 1 May 2017.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension and Cardiac Arrhythmias, run by Elpen Pharmaceutical Co. Inc. at 2 sites 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 6 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 1 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Blood pressure measurement (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 May 2017.