Essential HypertensionNCT02449811
RAS Peptide Profiles in Patients With Arterial Hypertension
An observational study of Essential Hypertension, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
Randomized, open-label, parallel-group study conducted at a single center in Switzerland. Patients diagnosed with primary arterial hypertension requiring antihypertensive drug Treatment as well as patients after a 4 week wash out period (Amendment 07/2016) will be recruited at the University Hospital Basel… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Essential Hypertension
- What is being tested?
- Perindopril, Olmesartan and Amlodipine
- Type of treatment
- Pill or oral medicine
- How many people
- 107 participants
- Where
- 1 siteSwitzerland
- Study dates
- Apr 2015to Nov 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Community sample
Who may be able to join
- Male or female outpatients with previously untreated non-secondary arterial hypertension, defined as: office-systolic blood pressure ≥ 140 mmHg and ≤ 180 mmHg and office-diastolic blood pressure ≥ 90 mmHg and ≤110 mmHg (ESH grade I and II hypertension).
- Male or female outpatients with previously treated non-secondary arterial Hypertension after a wash out period of 4 weeks (Amendment 07/2016)
- Evaluation of 24h blood pressure measurement fulfills criteria of hypertension: mean systolic blood pressure / diastolic blood pressure ≥ 130/80 on average, ≥ 135/85 during the day, or ≥ 120/70 during the night.
- Age ≥ 18 years
- Body mass index between 18 and 35 kg/m²
- Body weight at least 50 kg
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- Ability to understand study procedures and to provide written informed consent
- Hematology and clinical chemistry results not deviating from the normal range to a clinically relevant extent at screening.
- 12-lead ECG without clinically relevant abnormalities (Exception: signs of left ventricular hypertrophy with Sokolow index >3.5mV).
- Female study participants less than one year post-menopausal must, be non-pregnant and non-lactating, and willing to use an adequate and highly effective method of contraception throughout the study and for 1 week after the last dose. A highly effective method of birth control is defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as, implants, injectables, combined oral contraceptives, some intrauterine devices (IUD) (hormonal) in combination with a condom or sterilisation, sexual abstinence or vasectomised partner.
Who cannot join
- Pregnant or lactating women
- Clinical chemistry results indicating secondary arterial hypertension.
- History of or clinically evident cardiovascular disease (other than arterial hypertension), namely myocardial infarction and valvular heart disease or heart failure.
- Ventricular or dual pacemaker wearers
- Uni- or bilateral renal artery stenosis
- Renal dysfunction, defined as estimated creatinine-clearance < 60 ml/min
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- Recipient of kidney transplant
- Moderate or severe hepatic impairment
- Clinically relevant lung disease (e.g. uncontrolled bronchial asthma, chronic obstructive pulmonary disease (COPD))
- History of alcohol abuse
- Loss of ≥ 250 ml of blood within 3 months prior to screening.
- Known hypersensitivity to any of the four antihypertensive drugs or any excipients of the drug formulations
- History or clinical evidence of any disease and / or existence of any surgical or medical condition, which might interfere with the absorption, distribution, metabolism or excretion of the study drugs, or which might increase the risk for toxicity.
- Participation in another clinical trial within past 30 days
- Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single-center, Randomized, Open-label, Parallel-group Study to Characterize Renin-angiotensin-system (RAS) Peptide Profiles Before and After Treatment Initiation With Different Antihypertensive Drug-classes in Patients With Treatment-naive Arterial Hypertension
Randomized, open-label, parallel-group study conducted at a single center in Switzerland.
Patients diagnosed with primary arterial hypertension requiring antihypertensive drug Treatment as well as patients after a 4 week wash out period (Amendment 07/2016) will be recruited at the University Hospital Basel, Switzerland. Subjects will be randomized to either the angiotensin-converting enzyme inhibitor-, angiotensin receptor blocker-, calcium channel blocker- or hydrochlorothiazide-treatment arm. Drug treatment follows current guidelines issued by the European Society of Hypertension. Treatment-naive patients will be started on an intermediate dose monotherapy (treatment period 1). In all patients who do not reach blood pressure targets after 4 weeks, the dose of the monotherapy drug will be doubled (high dose, treatment period 2). Sampling for the analysis of RAS peptide profiles, measurement of drug concentrations in plasma and non-invasive hemodynamic measurements will be done. A control group with 20 age and gender matched, healthy and normotensive subjects will be recruited to establish the characteristics of the RAS peptide profiles in a comparable but normotensive population.
Read the detailed description
This will be a single-center, randomized, open-label, parallel-group study in patients with treatment-naive arterial hypertension to characterize RAS peptide profiles before and after treatment initiation with different antihypertensive drug-classes. Patients diagnosed with primary arterial hypertension requiring antihypertensive drug treatment as well as patients after a 4 week wash out period (Amendment from 07/2016) will be recruited from the Medical Outpatient Clinic at the University Hospital Basel, Switzerland. Diagnostic work-up and follow-up assessments after treatment initiation such as 24 hour blood pressure measurement will be performed according to clinical practice guidelines and will only be documented but not altered by this study. Study mandated procedures will be randomization to one of the four standard first-line treatment arms, blood sampling for RAS peptide profile and drug concentration determination, and non-invasive hemodynamic measurements. After having provided written informed consent, patients will be randomized to either the angiotensin-converting enzyme inhibitor-, angiotensin receptor blocker-, calcium channel blocker- or hydrochlorothiazide-treatment arm. Drug treatment follows current guidelines issued by the European Society of Hypertension . According to clinical practice, treatment-naive patients with grade I and grade II hypertension will directly be started on an intermediate dose monotherapy (treatment period 1).
Treatment period 1:
4 weeks of intermediate dose monotherapy with the angiotensin-converting enzyme Inhibitor perindopril OR the angiotensin receptor blocker olmesartan OR the calcium channel blocker amlodipine OR the hydrochlorothiazide
In all patients who do not reach blood pressure targets according to the 2013 ESH guidelines for the management of arterial hypertension after 4 weeks, the dose of the monotherapy drug will be doubled (high dose, treatment period 2), following current guidelines
Treatment period 2:
4 weeks of high dose monotherapy with the angiotensin-converting enzyme inhibitor perindopril OR the angiotensin receptor blocker olmesartan OR the calcium channel blocker amlodipine OR the hydrochlorothiazide
80 patients (20 patients per treatment arm) will be included and sampling for the analysis of RAS peptide profiles will be done before treatment initiation (baseline). Sampling for the analysis of RAS peptide profiles and measurement of drug concentrations in plasma will be done after 4 weeks of each treatment period at 0h (before last drug intake) and 4 hours after last drug intake of treatment period. Dropouts will be replaced. Non-invasive hemodynamic measurements will be done at the same time points as for the determination of RAS peptide profiles and drug concentrations.
A control group with 20 age- and gender-matched, healthy and normotensive subjects will be recruited to establish the characteristics of RAS peptide profiles in a comparable but normotensive population. After having provided written informed consent, normal blood pressure will be documented by a 24h blood pressure measurement. In this normotensive control group, blood sampling for the determination of RAS peptide profiles as well as hemodynamic measurements will only be done on a single day, at the same time of day as for the hypertensive patients. (Amendment 04/2015)
- Conditions
- Essential Hypertension
- Being tested
- Perindopril, Olmesartan, Amlodipine, Hydrochlorothiazide
- Medical subject headings
- Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PerindoprilDrug
OlmesartanDrug
AmlodipineDrug
HydrochlorothiazideDrug
| Study group | Role | What they receive |
|---|---|---|
| Perindopril | Treatment period 1: Perindopril 5mg, oral, once daily, for 4 weeks Treatment period 2: Perindopril 10mg, oral, once daily, for 4 weeks Receives: Drug: Perindopril | |
| Olmesartan | Treatment period 1: Olmesartan 20mg, oral, once daily, for 4 weeks Treatment period 2: Olmesartan 40mg, oral, once daily, for 4 weeks Receives: Drug: Olmesartan | |
| Amlodipine | Treatment period 1: Amlodipine 5mg, oral, once daily, for 4 weeks Treatment period 2: Amlodipine 10mg, oral, once daily, for 4 weeks Receives: Drug: Amlodipine | |
| Hydrochlorothiazide | Treatment period 1: Hydrochlorothiazide 25mg, oral, once daily, for 4 weeks Treatment period 2: Hydrochlorothiazide 50mg, oral, once daily, for 4 weeks Receives: Drug: Hydrochlorothiazide |
What is being measured
The primary outcome is the main question the study is designed to answer.
RAS peptide profiles
Concentration measurement of the different RAS peptides
Measured: 0h and 4h
Secondary outcomes (3)
Composite measure of Non-invasive hemodynamic parameters
Composite measure of Non-invasive hemodynamic parameters to include: Cardiac index, Stroke index, Mean arterial pressure, Ejection phase contractility index, Inotropic state index, Left stroke work index, Stroke systemic vascular resistance index, Thoracic fluid conductivity
Measured: 0h and 4h
Plasma renin activity and aldosterone concentration
Measured: 0h and 4h
Antihypertensive drug concentrations
Measured: 0h and 4h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2015 (estimated)
- Study startApr 2015
- Primary completionAug 2018
- Study completionNov 2018
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.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- 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
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Manuel Haschke, Prof. Dr. med., Principal investigator, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02449811
- Sponsor's protocol ID
- EKNZ 2015-081
- Status last verified
- Feb 2019
- First submitted
- 10 Apr 2015
- Last updated
- 22 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-center, Randomized, Open-label, Parallel-group Study to Characterize Renin-angiotensin-system (RAS) Peptide Profiles Before and After Treatment Initiation With Different Antihypertensive Drug-classes in Patients With Treatment-naive Arterial Hypertension
- ClinicalTrials.gov ID
- NCT02449811
- Acronym / sponsor ID
- EKNZ 2015-081
- Conditions
- Essential Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- Apr 2015 (actual)
- Primary completion
- Aug 2018 (actual)
- Study completion
- Nov 2018 (actual)
- First posted
- 20 May 2015 (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.
Randomized, open-label, parallel-group study conducted at a single center in Switzerland.
Patients diagnosed with primary arterial hypertension requiring antihypertensive drug Treatment as well as patients after a 4 week wash out period (Amendment 07/2016) will be recruited at the University Hospital Basel, Switzerland. Subjects will be randomized to either the angiotensin-converting enzyme inhibitor-, angiotensin receptor blocker-, calcium channel blocker- or hydrochlorothiazide-treatment arm. Drug treatment follows current guidelines issued by the European Society of Hypertension. Treatment-naive patients will be started on an intermediate dose monotherapy (treatment period 1). In all patients who do not reach blood pressure targets after 4 weeks, the dose of the monotherapy drug will be doubled (high dose, treatment period 2). Sampling for the analysis of RAS peptide profiles, measurement of drug concentrations in plasma and non-invasive hemodynamic measurements will be done. A control group with 20 age and gender matched, healthy and normotensive subjects will be recruited to establish the characteristics of the RAS peptide profiles in a comparable but normotensive population.
Detailed description
This will be a single-center, randomized, open-label, parallel-group study in patients with treatment-naive arterial hypertension to characterize RAS peptide profiles before and after treatment initiation with different antihypertensive drug-classes. Patients diagnosed with primary arterial hypertension requiring antihypertensive drug treatment as well as patients after a 4 week wash out period (Amendment from 07/2016) will be recruited from the Medical Outpatient Clinic at the University Hospital Basel, Switzerland. Diagnostic work-up and follow-up assessments after treatment initiation such as 24 hour blood pressure measurement will be performed according to clinical practice guidelines and will only be documented but not altered by this study. Study mandated procedures will be randomization to one of the four standard first-line treatment arms, blood sampling for RAS peptide profile and drug concentration determination, and non-invasive hemodynamic measurements. After having provided written informed consent, patients will be randomized to either the angiotensin-converting enzyme inhibitor-, angiotensin receptor blocker-, calcium channel blocker- or hydrochlorothiazide-treatment arm. Drug treatment follows current guidelines issued by the European Society of Hypertension . According to clinical practice, treatment-naive patients with grade I and grade II hypertension will directly be started on an intermediate dose monotherapy (treatment period 1).
Treatment period 1:
4 weeks of intermediate dose monotherapy with the angiotensin-converting enzyme Inhibitor perindopril OR the angiotensin receptor blocker olmesartan OR the calcium channel blocker amlodipine OR the hydrochlorothiazide
In all patients who do not reach blood pressure targets according to the 2013 ESH guidelines for the management of arterial hypertension after 4 weeks, the dose of the monotherapy drug will be doubled (high dose, treatment period 2), following current guidelines
Treatment period 2:
4 weeks of high dose monotherapy with the angiotensin-converting enzyme inhibitor perindopril OR the angiotensin receptor blocker olmesartan OR the calcium channel blocker amlodipine OR the hydrochlorothiazide
80 patients (20 patients per treatment arm) will be included and sampling for the analysis of RAS peptide profiles will be done before treatment initiation (baseline). Sampling for the analysis of RAS peptide profiles and measurement of drug concentrations in plasma will be done after 4 weeks of each treatment period at 0h (before last drug intake) and 4 hours after last drug intake of treatment period. Dropouts will be replaced. Non-invasive hemodynamic measurements will be done at the same time points as for the determination of RAS peptide profiles and drug concentrations.
A control group with 20 age- and gender-matched, healthy and normotensive subjects will be recruited to establish the characteristics of RAS peptide profiles in a comparable but normotensive population. After having provided written informed consent, normal blood pressure will be documented by a 24h blood pressure measurement. In this normotensive control group, blood sampling for the determination of RAS peptide profiles as well as hemodynamic measurements will only be done on a single day, at the same time of day as for the hypertensive patients. (Amendment 04/2015)
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Perindopril | – | Drug: PerindoprilTreatment period 1: Perindopril 5mg, oral, once daily, for 4 weeks Treatment period 2: Perindopril 10mg, oral, once daily, for 4 weeks |
| Olmesartan | – | Drug: OlmesartanTreatment period 1: Olmesartan 20mg, oral, once daily, for 4 weeks Treatment period 2: Olmesartan 40mg, oral, once daily, for 4 weeks |
| Amlodipine | – | Drug: AmlodipineTreatment period 1: Amlodipine 5mg, oral, once daily, for 4 weeks Treatment period 2: Amlodipine 10mg, oral, once daily, for 4 weeks |
| Hydrochlorothiazide | – | Drug: HydrochlorothiazideTreatment period 1: Hydrochlorothiazide 25mg, oral, once daily, for 4 weeks Treatment period 2: Hydrochlorothiazide 50mg, oral, once daily, for 4 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Community sample
Key inclusion criteria (10 listed)
- Male or female outpatients with previously untreated non-secondary arterial hypertension, defined as: office-systolic blood pressure ≥ 140 mmHg and ≤ 180 mmHg and office-diastolic blood pressure ≥ 90 mmHg and ≤110 mmHg (ESH grade I and II hypertension).
- Male or female outpatients with previously treated non-secondary arterial Hypertension after a wash out period of 4 weeks (Amendment 07/2016)
- Evaluation of 24h blood pressure measurement fulfills criteria of hypertension: mean systolic blood pressure / diastolic blood pressure ≥ 130/80 on average, ≥ 135/85 during the day, or ≥ 120/70 during the night.
- Age ≥ 18 years
- Body mass index between 18 and 35 kg/m²
Key exclusion criteria (15 listed)
- Pregnant or lactating women
- Clinical chemistry results indicating secondary arterial hypertension.
- History of or clinically evident cardiovascular disease (other than arterial hypertension), namely myocardial infarction and valvular heart disease or heart failure.
- Ventricular or dual pacemaker wearers
- Uni- or bilateral renal artery stenosis
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 |
|---|---|---|
| Perindopril | Drug | Perindopril |
| Olmesartan | Drug | Olmesartan |
| Amlodipine | Drug | Amlodipine |
| Hydrochlorothiazide | Drug | Hydrochlorothiazide |
Primary outcome
RAS peptide profiles
Time frame: 0h and 4h
Concentration measurement of the different RAS peptides
3 secondary outcomes
Composite measure of Non-invasive hemodynamic parameters
Time frame: 0h and 4h
Plasma renin activity and aldosterone concentration
Time frame: 0h and 4h
Antihypertensive drug concentrations
Time frame: 0h and 4h
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 22 Feb 2019.
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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.
Manuel Haschke, Prof. Dr. med. principal investigator
University of Bern
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 Essential Hypertension, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 10 inclusion and 15 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 22 Feb 2019. 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 Switzerland. 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?
RAS peptide profiles (time frame: 0h and 4h). 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 22 Feb 2019.