Hypertension, Resistant to Conventional TherapyPOP-ARTNCT02385864
CPAP Effect on Blood Pressure and Arterial Stiffness in Obstructive Sleep Apnea Patients With Resistant Hypertension
An observational study of Hypertension, Resistant to Conventional Therapy and Obstructive Sleep Apnea, run by University Hospital, Grenoble at 4 sites in France.
Trial summary
Resistant hypertension is defined as uncontrolled blood pressure (BP ≥ 140/90mmHg) despite the current use of three or more antihypertensive drugs at full doses, including a diuretic. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypertension, Resistant to Conventional Therapy, Obstructive Sleep Apnea
- How many people
- 166 participants
- Where
- 4 sitesFrance
- Study dates
- Sep 2015to Feb 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with resistant hypertension
Who may be able to join
- Patient with resistant hypertension uncontrolled by 3 or more antihypertensive agents
- Patient with severe OSA (apnea-hypopnea index > 30 or > or equal to 15 with excessive daytime sleepiness), or with mild to moderate OSA without excessive daytime sleepiness, or without OSA.
- Ambulatory patient
Who cannot join
- Body mass index ≥40 kg/m2
- Other identifiable causes of hypertension
- Contraindication to CPAP treatment or patient already treated with CPAP
Trial locations and contacts
4 sites in 1 country.
France4 sites, 4 recruiting
- Recruiting
Clinique du Tondu
Bordeaux, 33000
Olivier Coste, MD, (+33) 5 56 99 62 67, olivier.coste@gmail.com
- Recruiting
Bordeaux University Hospital
Bordeaux, 33075
Philippe Gosse, Md, PhD, (+33)5 56 79 58 89, philippe.gosse@chu-bordeaux.fr
- Recruiting
Clinique des Eaux Claires, Groupe Hospitalier Mutualiste
Grenoble, 38000
Jean-Philippe Baguet, MD, PhD, (+33)4 76 70 70 54, jpbaguet@ghm-grenoble.fr
Christophe Dessus, (+33) 4 76 70 76 98, c.dessus@ghm-grenoble.fr
- Recruiting
Grenoble University Hospital
Grenoble, 38700
Gilles Barone-Rochette, MD, PhD, (+33) 4 76 76 51 72, gbarone@chu-grenoble.fr
Jean-Louis Pepin, MD, PhD, (+33)4 76 76 92 65, jpepin@chu-grenoble.fr
About this study
Official title: Effect of the Continuous Positive Airway Pressure on Blood Pressure and Arterial Stiffness in Obstructive Sleep Apnea Patients With Resistant Hypertension
Resistant hypertension is defined as uncontrolled blood pressure (BP ≥ 140/90mmHg) despite the current use of three or more antihypertensive drugs at full doses, including a diuretic. Obstructive Sleep Apnea (OSA) is at high risk for cardiovascular morbidity and is highly prevalent in patients with resistant hypertension.
The prospective observational POP-ART study will assess the efficacy of continuous positive airway pressure (CPAP) treatment on BP in patients with resistant hypertension and collect data from usual care.
Read the detailed description
Obstructive Sleep Apnea is highly prevalent in patients with resistant hypertension and several studies have assessed the effect of CPAP treatment on BP.
But only few studies have raised data about the effect of CPAP treatment on BP in patients with resistant hypertension.
Hypertension is moreover associated with increased arterial stiffness, but no data are available in patients with resistant hypertension.
The purpose of this study is to demonstrate that OSA has a major impact in resistant hypertension, whose effects on BP and arterial stiffness can partially be reversible with CPAP treatment.
- Medical subject headings
- Hypertension Resistant to Conventional Therapy, Sleep Apnea, Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean variation in BP at 6 months, assessed by 24h ambulatory BP monitoring
Measured: 6 months from baseline assessment
Secondary outcomes (5)
OSA prevalence in patients with resistant hypertension
Measured: 6 months
BP variability assessed by home self BP measurments
Measured: 6 months
Arterial stiffness assessed by pulse wave velocity and QKD interval
Measured: 6 months
Antihypertensive treatment consumption
Measured: 6 months
CPAP treatment observance
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2015 (estimated)
- Study startSep 2015
- Primary completionAug 2016 (estimated)
- Study completionFeb 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension, Resistant to Conventional TherapyStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 166 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Philippe Baguet, MD, PhD, Principal investigator, Groupe Hospitalier Mutualiste, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02385864
- Sponsor's protocol ID
- 2013-A00908-37
- Acronym
- POP-ART
- Status last verified
- Mar 2016
- First submitted
- 26 Feb 2015
- Last updated
- 7 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Continuous Positive Airway Pressure on Blood Pressure and Arterial Stiffness in Obstructive Sleep Apnea Patients With Resistant Hypertension
- ClinicalTrials.gov ID
- NCT02385864
- Acronym / sponsor ID
- POP-ART / 2013-A00908-37
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 166 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Feb 2017 (estimated)
- First posted
- 11 Mar 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.
Resistant hypertension is defined as uncontrolled blood pressure (BP ≥ 140/90mmHg) despite the current use of three or more antihypertensive drugs at full doses, including a diuretic. Obstructive Sleep Apnea (OSA) is at high risk for cardiovascular morbidity and is highly prevalent in patients with resistant hypertension.
The prospective observational POP-ART study will assess the efficacy of continuous positive airway pressure (CPAP) treatment on BP in patients with resistant hypertension and collect data from usual care.
Detailed description
Obstructive Sleep Apnea is highly prevalent in patients with resistant hypertension and several studies have assessed the effect of CPAP treatment on BP.
But only few studies have raised data about the effect of CPAP treatment on BP in patients with resistant hypertension.
Hypertension is moreover associated with increased arterial stiffness, but no data are available in patients with resistant hypertension.
The purpose of this study is to demonstrate that OSA has a major impact in resistant hypertension, whose effects on BP and arterial stiffness can partially be reversible with CPAP treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with resistant hypertension
Key inclusion criteria (3 listed)
- Patient with resistant hypertension uncontrolled by 3 or more antihypertensive agents
- Patient with severe OSA (apnea-hypopnea index > 30 or > or equal to 15 with excessive daytime sleepiness), or with mild to moderate OSA without excessive daytime sleepiness, or without OSA.
- Ambulatory patient
Key exclusion criteria (3 listed)
- Body mass index ≥40 kg/m2
- Other identifiable causes of hypertension
- Contraindication to CPAP treatment or patient already treated with CPAP
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
Mean variation in BP at 6 months, assessed by 24h ambulatory BP monitoring
Time frame: 6 months from baseline assessment
5 secondary outcomes
OSA prevalence in patients with resistant hypertension
Time frame: 6 months
BP variability assessed by home self BP measurments
Time frame: 6 months
Arterial stiffness assessed by pulse wave velocity and QKD interval
Time frame: 6 months
Antihypertensive treatment consumption
Time frame: 6 months
CPAP treatment observance
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2016.
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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.
Jean-Philippe Baguet, MD, PhD principal investigator
Groupe Hospitalier Mutualiste, Grenoble
4 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, Resistant to Conventional Therapy and Obstructive Sleep Apnea, run by University Hospital, Grenoble at 4 sites in France.
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 3 inclusion and 3 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 7 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gilles Barone-Rochette, MD, PhD ((+33) 4 76 76 51 72, gbarone@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean variation in BP at 6 months, assessed by 24h ambulatory BP monitoring (time frame: 6 months from baseline assessment). 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 7 Mar 2016.