Essential HypertensionPhase 3NCT00659451
Effects Of Losartan On Myocardial Structure In Diabetic Hypertensive Patients With Left Ventricular
A Phase 3 study testing Losartan and Amlodipine in people with Essential Hypertension and Diabetes Mellitus, run by University of Pavia at 1 site in Italy.
Trial summary
The anthypertensive treatment with Losartan may have benefits beyond blood pressure reduction on myocardial structure and function in hypertensive diabetic patients. We will evaluate the effect of losartan treatment on structural characteristics of myocardium in hypertensive diabetic patients: 1. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Essential Hypertension, Diabetes Mellitus
- What is being tested?
- Losartan and Amlodipine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2008to Apr 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Gender: 50% Male and 50 % female
- Age: 40-80 years
- Race: caucasian
- Well controlled type II Diabetes : fasting glicemia < 126 mg/dl in two different determinantion or any non fasting glicemia > 200 mg/dl; HbA1c < 7%
- Mild to moderate hypertension (BP>130/80mmHg; <160/100mmHg)
- Left ventricular hypertrophy (LVMI > 131/110 g/m2 in males/females respectively)
Who cannot join
- other anthypertensive treatment after wash out period of 2 weeks
- abnormal heart rest function (EF < 55%).
- valvular heart disease
- congenital heart disease
- heart failure or prior myocardial infarction
- renal disease
Show all 11Show fewer
- liver disease
- connective tissue disease
- pregnancy or lactation
- sensitivity to the study drugs
- contraindication from an approved label
Trial locations and contacts
1 site in 1 country.
Roberto Fogari contact
Italy1 site, 1 recruiting
- Recruiting
University of Pavia
Pavia
Paola Preti, MD, +39 0382 526217
Paola Preti
About this study
Official title: Effects Of Losartan On Myocardial Structure And Function And On Epicardial Fat Deposition In Diabetic Hypertensive Patients With Left Ventricular: Qualitative And Quantitative Alteration
The anthypertensive treatment with Losartan may have benefits beyond blood pressure reduction on myocardial structure and function in hypertensive diabetic patients. We will evaluate the effect of losartan treatment on structural characteristics of myocardium in hypertensive diabetic patients:
- left ventricular mass, intraventricular septal thickness, fractional shortening.
- myocardial qualitative alteration and heterogeneity of myocardial tissue that describes myocardial texture and echodensity, related to collagen deposition; myocardial qualitative alteration will be evaluate by ultrasonic myocardial integrated backscatter signals (IBS) both as peak end diastolic signal intensity and as cardiac cyclic variation
- alteration of diastolic function as studied by Doppler flow velocities across the mitral valve (Pulse Wave Doppler) and pulse wave Tissue Doppler Imaging parameters
- aortic strain and distensibility (that is in relation with LVH)
- epicardial adipose tissue measurement (this parameter is related to the visceral fat and may be an easy method to indicate patients with high cardiovascular risk).
- Conditions
- Essential Hypertension, Diabetes Mellitus
- Being tested
- Losartan, Amlodipine
- Keywords
- Hypertension, Diabetes mellitus, Heart
- Medical subject headings
- Essential Hypertension, Diabetes Mellitus, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LosartanDrug
tablets; 50, 100 mg; od; 12 months
AmlodipineDrug
tablets; 5, 10 mg; od; 12 months
| Study group | Role | What they receive |
|---|---|---|
| 2 | Experimental | Losartan Receives: Drug: Losartan |
| 1 | Active comparator | Amlodipine Receives: Drug: Amlodipine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricular mass, intraventricular septal thickness, fractional shortening; myocardial qualitative and diastolic function alteration; aortic strain and distensibility.
Measured: Between 08.00 and 10.00 at baseline, and after 3, 6, and 12 months
Secondary outcomes (1)
Heterogeneity of myocardial tissue; epicardial adipose tissue measurement
Measured: Between 08.00 and 10.00 at baseline, and after 3, 6, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionApr 2008
- Study completionApr 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential 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
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pavia
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00659451
- Sponsor's protocol ID
- UNIPV002DIM2008
- Status last verified
- Apr 2008
- First submitted
- 14 Apr 2008
- Last updated
- 16 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Of Losartan On Myocardial Structure And Function And On Epicardial Fat Deposition In Diabetic Hypertensive Patients With Left Ventricular: Qualitative And Quantitative Alteration
- ClinicalTrials.gov ID
- NCT00659451
- Acronym / sponsor ID
- UNIPV002DIM2008
- Conditions
- Essential Hypertension, Diabetes Mellitus
- Keywords
- Hypertension, Diabetes mellitus, Heart
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of PaviaUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2009 (estimated)
- First posted
- 16 Apr 2008 (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 anthypertensive treatment with Losartan may have benefits beyond blood pressure reduction on myocardial structure and function in hypertensive diabetic patients. We will evaluate the effect of losartan treatment on structural characteristics of myocardium in hypertensive diabetic patients:
- left ventricular mass, intraventricular septal thickness, fractional shortening.
- myocardial qualitative alteration and heterogeneity of myocardial tissue that describes myocardial texture and echodensity, related to collagen deposition; myocardial qualitative alteration will be evaluate by ultrasonic myocardial integrated backscatter signals (IBS) both as peak end diastolic signal intensity and as cardiac cyclic variation
- alteration of diastolic function as studied by Doppler flow velocities across the mitral valve (Pulse Wave Doppler) and pulse wave Tissue Doppler Imaging parameters
- aortic strain and distensibility (that is in relation with LVH)
- epicardial adipose tissue measurement (this parameter is related to the visceral fat and may be an easy method to indicate patients with high cardiovascular risk).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Experimental | Drug: LosartanLosartan |
| 1 | Active comparator | Drug: AmlodipineAmlodipine |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Gender: 50% Male and 50 % female
- Age: 40-80 years
- Race: caucasian
- Well controlled type II Diabetes : fasting glicemia < 126 mg/dl in two different determinantion or any non fasting glicemia > 200 mg/dl; HbA1c < 7%
- Mild to moderate hypertension (BP>130/80mmHg; <160/100mmHg)
Key exclusion criteria (11 listed)
- other anthypertensive treatment after wash out period of 2 weeks
- abnormal heart rest function (EF < 55%).
- valvular heart disease
- congenital heart disease
- heart failure or prior myocardial infarction
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 |
|---|---|---|
| Losartantablets; 50, 100 mg; od; 12 months | Drug | 2 |
| Amlodipinetablets; 5, 10 mg; od; 12 months | Drug | 1 |
Primary outcome
Left ventricular mass, intraventricular septal thickness, fractional shortening; myocardial qualitative and diastolic function alteration; aortic strain and distensibility.
Time frame: Between 08.00 and 10.00 at baseline, and after 3, 6, and 12 months
1 secondary outcome
Heterogeneity of myocardial tissue; epicardial adipose tissue measurement
Time frame: Between 08.00 and 10.00 at baseline, and after 3, 6, and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2008.
Related trials for Essential Hypertension
Recruiting
The Effect of Self-Acupressure on Blood Pressure, Stress, and Well-Being Levels in Individuals With Hypertension
PRIMARY HYPERTENSION
Active, not recruiting
Smartphone-Guided Paced Breathing and Aerobic Exercise for Essential Hypertension
Essential (Primary) Hypertension
Recruiting
Isometric Resistance Exercise on Accelerated Atherosclerosis in Hypertension
Atherosclerosis Cardiovascular Disease
Not yet recruitingObservational study
A Study to Evaluate the Effectiveness and Safety of S-amlodipine-based Monotherapy and Combination Therapy
Hypertension (HTN), Hypertension
Recruiting
Community Health Worker Support to Lower Blood Pressure After a Pregnancy With High Blood Pressure
Pregnancy-Associated Hypertension, Gestational Hypertension
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.
Roberto Fogari contact
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 Losartan and Amlodipine in people with Essential Hypertension and Diabetes Mellitus, run by University of Pavia at 1 site in Italy.
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 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: status not confirmed, as of the sponsor's last update on 16 Apr 2008. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Roberto Fogari (+39 0382 526217), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left ventricular mass, intraventricular septal thickness, fractional shortening; myocardial qualitative and diastolic function alteration; aortic strain and distensibility. (time frame: Between 08.00 and 10.00 at baseline, and after 3, 6, and 12 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 16 Apr 2008.