HypertensionNCT02962778
RAS Peptide Profiles in Patients With Treatment-resistant Arterial Hypertension
An observational study of Hypertension, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
This study evaluates RAS peptides profiles in patients with treatment resistant arterial hypertension. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2016to 11 Oct 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Male or female outpatients fulfilling criteria for treatment-resistant arterial hypertension
Who may be able to join
- Office blood pressure ≥ 140/90 mmHg and mean 24 hour blood pressure >130/80 mmHg on average, or >135/85 mmHg during the day, or > 120/70 mmHg during the night, despite concurrent use of 3 antihypertensive agents at optimal doses, including one diuretic OR
- Office blood pressure and 24 hour mean blood pressure controlled with four or more medications
- Age ≥ 18 years
- Ability to understand research procedures and to provide written informed consent
Who cannot join
- Known secondary arterial hypertension at time of inclusion or diagnosis of secondary hypertension after study inclusion during routine work-up of treatment resistant hypertension
- Known obstructive sleep apnea at time of inclusion
- History of, or clinically relevant or uncontrolled cardiovascular disease (other than arterial hypertension), namely myocardial infarction within last 3 months or valvular heart disease with clinically relevant reflux or heart failure
- Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the research project or compliance with the research plan.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Renin-angiotensin-system (RAS) Peptide Profiles in Patients With Treatment-resistant Arterial Hypertension (TRHT-01 Study). An Observational Single Centre Study
This study evaluates RAS peptides profiles in patients with treatment resistant arterial hypertension.
Read the detailed description
Selective quantification of RAS peptides in human plasma triggered investigations evaluating whether RAS peptides could be used as clinical biomarkers in patients receiving antihypertensive treatment.
Drug-specific RAS profiles first characterized in healthy normotensive subjects (EKBB 255/12; ClinicalTrials.gov ID NCT01771783) are presently investigated in patients with newly diagnosed arterial hypertension (EKNZ 2015-081; clinicaltrials.gov identifier (ID) NCT02449811). With this observational study RAS peptide profiles will be characterized in patients with treatment resistant hypertension. Data generated by this study will show whether RAS peptide profiles merit further evaluation as clinical biomarkers in this complex patient group.
- Conditions
- Hypertension
- Keywords
- treatment-resistant
- Medical subject headings
- Hypertension
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 |
|---|---|---|
| treatment-resistant hypertension | patients with Treatment-resistant arterial hypertension receiving standard antihypertensive treatment with at least 3 antihypertensive agents including one diuretic |
What is being measured
The primary outcome is the main question the study is designed to answer.
RAS peptide concentrations in plasma
Measured: baseline, 4h after observed drug intake and steady-state sample
Secondary outcomes (1)
Antihypertensive drug concentrations in plasma
Measured: baseline, 4h after observed drug intake and steady-state sample
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2016 (estimated)
- Study startOct 2016
- Primary completionOct 2017
- Study completion11 Oct 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.
- More trials run by University Hospital, Basel, SwitzerlandThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Manuel Haschke, MD, Dr., Principal investigator, Insel Gruppe AG, University Hospital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02962778
- Sponsor's protocol ID
- TRHT-01 Study
- Status last verified
- Feb 2018
- First submitted
- 9 Nov 2016
- Last updated
- 28 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: The results of this research project will be published in an appropriate scientific journal.
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renin-angiotensin-system (RAS) Peptide Profiles in Patients With Treatment-resistant Arterial Hypertension (TRHT-01 Study). An Observational Single Centre Study
- ClinicalTrials.gov ID
- NCT02962778
- Acronym / sponsor ID
- TRHT-01 Study
- Conditions
- Hypertension
- Keywords
- treatment-resistant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- 11 Oct 2017 (actual)
- First posted
- 11 Nov 2016 (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.
This study evaluates RAS peptides profiles in patients with treatment resistant arterial hypertension.
Detailed description
Selective quantification of RAS peptides in human plasma triggered investigations evaluating whether RAS peptides could be used as clinical biomarkers in patients receiving antihypertensive treatment.
Drug-specific RAS profiles first characterized in healthy normotensive subjects (EKBB 255/12; ClinicalTrials.gov ID NCT01771783) are presently investigated in patients with newly diagnosed arterial hypertension (EKNZ 2015-081; clinicaltrials.gov identifier (ID) NCT02449811). With this observational study RAS peptide profiles will be characterized in patients with treatment resistant hypertension. Data generated by this study will show whether RAS peptide profiles merit further evaluation as clinical biomarkers in this complex patient group.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment-resistant hypertension | – | –patients with Treatment-resistant arterial hypertension receiving standard antihypertensive treatment with at least 3 antihypertensive agents including one diuretic |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male or female outpatients fulfilling criteria for treatment-resistant arterial hypertension
Key inclusion criteria (4 listed)
- Office blood pressure ≥ 140/90 mmHg and mean 24 hour blood pressure >130/80 mmHg on average, or >135/85 mmHg during the day, or > 120/70 mmHg during the night, despite concurrent use of 3 antihypertensive agents at optimal doses, including one diuretic OR
- Office blood pressure and 24 hour mean blood pressure controlled with four or more medications
Key exclusion criteria (4 listed)
- Known secondary arterial hypertension at time of inclusion or diagnosis of secondary hypertension after study inclusion during routine work-up of treatment resistant hypertension
- Known obstructive sleep apnea at time of inclusion
- History of, or clinically relevant or uncontrolled cardiovascular disease (other than arterial hypertension), namely myocardial infarction within last 3 months or valvular heart disease with clinically relevant reflux or heart failure
- Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the research project or compliance with the research plan.
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
RAS peptide concentrations in plasma
Time frame: baseline, 4h after observed drug intake and steady-state sample
1 secondary outcome
Antihypertensive drug concentrations in plasma
Time frame: baseline, 4h after observed drug intake and steady-state sample
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 28 Feb 2018.
- Individual participant dataSharing planned: No. The results of this research project will be published in an appropriate scientific journal.
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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, MD, Dr. principal investigator
Insel Gruppe AG, University Hospital 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 Hypertension, run by University Hospital, Basel, Switzerland 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 4 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 28 Feb 2018. 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 concentrations in plasma (time frame: baseline, 4h after observed drug intake and steady-state sample). 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 28 Feb 2018.