Treatment Resistant HypertensionSPIRITNCT03078244
Protocol for a Multicentre Survey of Patients With Treatment Resistant Hypertension
An observational study of Treatment Resistant Hypertension, run by Emerald Clinical Inc..
Trial summary
Project aims to determine the number of individuals with treatment resistant hypertension and to define the characteristics of these patients and estimate disease frequency. The study will be a retrospective review of medical record data based upon de-identified information and will require no patient contact. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Treatment Resistant Hypertension
- What is being tested?
- N/A, observational study
- How many people
- 1,500 participants
- Where
- No sites listed yet
- Study dates
- Nov 2016to 31 Aug 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
- No healthy volunteers
- Adult, Older adult
Study population: Adult subjects with treatment resistant hypertension
Who may be able to join
- > = 18 years of age
- No known secondary cause of hypertension
- History of uncontrolled hypertension while using 3 or more anti-hypertensive agents
- Controlled blood pressure using 4 or more different anti-hypertensive agents
Who cannot join
- N/A
About this study
Project aims to determine the number of individuals with treatment resistant hypertension and to define the characteristics of these patients and estimate disease frequency. The study will be a retrospective review of medical record data based upon de-identified information and will require no patient contact.
- Conditions
- Treatment Resistant Hypertension
- Being tested
- N/A, observational study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N/A, observational studyOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adult subjects with treatment resistant hypertension
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2017
- Study startNov 2016
- Primary completion31 Aug 2017
- Study completion31 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment Resistant 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 1,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emerald Clinical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The George Institute, Actelion
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03078244
- Sponsor's protocol ID
- ACHT41
- Acronym
- SPIRIT
- Status last verified
- Feb 2018
- First submitted
- 8 Mar 2017
- Last updated
- 19 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol for a Multicentre Survey of Patients With Treatment Resistant Hypertension
- ClinicalTrials.gov ID
- NCT03078244
- Acronym / sponsor ID
- SPIRIT / ACHT41
- Conditions
- Treatment Resistant Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- Emerald Clinical Inc.Industry (pharma, biotech, devices)
- Collaborators
- The George Institute, Actelion
- Study start
- Nov 2016
- Primary completion
- 31 Aug 2017 (actual)
- Study completion
- 31 Aug 2017 (actual)
- First posted
- 13 Mar 2017 (actual)
- 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.
Project aims to determine the number of individuals with treatment resistant hypertension and to define the characteristics of these patients and estimate disease frequency. The study will be a retrospective review of medical record data based upon de-identified information and will require no patient contact.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult subjects with treatment resistant hypertension
Key inclusion criteria (4 listed)
- > = 18 years of age
- No known secondary cause of hypertension
- History of uncontrolled hypertension while using 3 or more anti-hypertensive agents
- Controlled blood pressure using 4 or more different anti-hypertensive agents
Key exclusion criteria (1 listed)
- N/A
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 |
|---|---|---|
| N/A, observational study | Other | – |
Primary outcome
Number of adult subjects with treatment resistant hypertension
Time frame: one year
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 19 Feb 2018.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Treatment Resistant Hypertension, run by Emerald Clinical Inc..
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 1 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 19 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Number of adult subjects with treatment resistant hypertension (time frame: one year). 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 19 Feb 2018.