HypertensionPhase 4NCT00929175
Antihypertensive Effect of Continuous Positive Airway Pressure in Resistant Hypertensive Patients With Sleep Apnea
A Phase 4 study testing active CPAP in people with Hypertension, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
Obstructive sleep apnea syndrome (OSAS) has been linked to resistant hypertension, but the effect of treatment of OSAS on the resistant hypertension have no been established. In a double-blind randomized clinical trial patients with resistant hypertension with at least moderate sleep apnea will be randomized to… Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Hypertension
- What is being tested?
- active CPAP
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2008to Apr 2013
- Phase
- Phase 4
- 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of resistant hypertension
- Apnea/hypopnea index > 15
Who cannot join
- Cardiac surgery on last 3 months
- Serious arrhythmias
- Insulin dependent diabetes
- Debilitating neurological disease
- severe COPD
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035003
About this study
Official title: Antihypertensive Effect of Continuous Positive Airway Pressure (CPAP) in Resistant Hypertensive Patients With Sleep Apnea: Randomized Clinical Trial
Obstructive sleep apnea syndrome (OSAS) has been linked to resistant hypertension, but the effect of treatment of OSAS on the resistant hypertension have no been established. In a double-blind randomized clinical trial patients with resistant hypertension with at least moderate sleep apnea will be randomized to receive therapeutic CPAP or Placebo CPAP for eight weeks in an ambulatory set. The investigators want to determine any difference on hypertension control between the 2 management strategies.
Read the detailed description
This is a double blind, randomized, placebo controlled trial. Participants were consecutive patients with resistant hypertension, defined as uncontrolled BP, despite the concurrent use of 3 or more antihypertensive agents, including a diuretic, with adherence to treatment and without white coat phenomenon. All participants should have a diagnosis of at least moderate OSAS, defined by AHI > 15 in a portable monitoring sleep exam. Participants were assigned to active CPAP or sham-CPAP. The main outcome was change in 24-hour ambulatory blood pressure (ABP) monitoring values from baseline to two months of active CPAP or sham CPAP
- Conditions
- Hypertension
- Being tested
- active CPAP, sham-CPAP
- Keywords
- Hypertension, Resistant Hypertension, Sleep apnea syndrome, Treatment
- Medical subject headings
- Hypertension, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active CPAPDevice
auto-PAP with pressure between 6 and 12 cm H2O or sham CPAP will be administered to randomized patients
sham-CPAPDevice
The sham-CPAP was the same equipment used for active CPAP (Respironics Remstar-Auto, Murraysville, PA) fixed in the lowest pressure (4cmH2) and modified as recommended by Farré et al. The differences between the two were undetectable except for the pressure generated in the facial mask in the sham-CPAP that was no greater than 1cm H2O.
| Study group | Role | What they receive |
|---|---|---|
| active CPAP | Active comparator | auto-PAP with therapeutic pressure Receives: Device: active CPAP |
| sham-CPAP | Sham comparator | auto-PAP with pressure less than 1cm H2O Receives: Device: sham-CPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure evaluated with ambulatory 24-hour blood pressure monitoring
Measured: 8 weeks after treatment
Secondary outcomes (1)
aldosterone, renin, activated protein C
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2009 (estimated)
- Study startFeb 2008
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Flavio D Fuchs, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00929175
- Sponsor's protocol ID
- 07-020
- Status last verified
- Apr 2013
- First submitted
- 9 Jun 2009
- Last updated
- 25 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
de Oliveira AC, Martinez D, Massierer D, Gus M, Goncalves SC, Ghizzoni F, Steinhorst AM, Moreira LB, Fuchs SC, Fuchs FD. The antihypertensive effect of positive airway pressure on resistant hypertension of patients with obstructive sleep apnea: a randomized, double-blind, clinical trial. Am J Respir Crit Care Med. 2014 Aug 1;190(3):345-7. doi: 10.1164/rccm.201403-0479LE. No abstract available.
PubMed 25084263
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antihypertensive Effect of Continuous Positive Airway Pressure (CPAP) in Resistant Hypertensive Patients With Sleep Apnea: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT00929175
- Acronym / sponsor ID
- 07-020
- Conditions
- Hypertension
- Keywords
- Hypertension, Resistant Hypertension, Sleep apnea syndrome, Treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 26 Jun 2009 (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.
Obstructive sleep apnea syndrome (OSAS) has been linked to resistant hypertension, but the effect of treatment of OSAS on the resistant hypertension have no been established. In a double-blind randomized clinical trial patients with resistant hypertension with at least moderate sleep apnea will be randomized to receive therapeutic CPAP or Placebo CPAP for eight weeks in an ambulatory set. The investigators want to determine any difference on hypertension control between the 2 management strategies.
Detailed description
This is a double blind, randomized, placebo controlled trial. Participants were consecutive patients with resistant hypertension, defined as uncontrolled BP, despite the concurrent use of 3 or more antihypertensive agents, including a diuretic, with adherence to treatment and without white coat phenomenon. All participants should have a diagnosis of at least moderate OSAS, defined by AHI > 15 in a portable monitoring sleep exam. Participants were assigned to active CPAP or sham-CPAP. The main outcome was change in 24-hour ambulatory blood pressure (ABP) monitoring values from baseline to two months of active CPAP or sham CPAP
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| active CPAP | Active comparator | Device: active CPAPauto-PAP with therapeutic pressure |
| sham-CPAP | Sham comparator | Device: sham-CPAPauto-PAP with pressure less than 1cm H2O |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of resistant hypertension
- Apnea/hypopnea index > 15
Key exclusion criteria (5 listed)
- Cardiac surgery on last 3 months
- Serious arrhythmias
- Insulin dependent diabetes
- Debilitating neurological disease
- severe COPD
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 |
|---|---|---|
| active CPAPauto-PAP with pressure between 6 and 12 cm H2O or sham CPAP will be administered to randomized patients | Device | active CPAP |
| sham-CPAPThe sham-CPAP was the same equipment used for active CPAP (Respironics Remstar-Auto, Murraysville, PA) fixed in the lowest pressure (4cmH2) and modified as recommended by Farré et al. The differences between the two were undetectable except for the pressure generated in the facial mask in the sham-CPAP that was no greater than 1cm H2O. | Device | sham-CPAP |
Primary outcome
Blood pressure evaluated with ambulatory 24-hour blood pressure monitoring
Time frame: 8 weeks after treatment
1 secondary outcome
aldosterone, renin, activated protein C
Time frame: 8 weeks
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 25 Feb 2014.
- Derived from this study: PubMed 25084263de Oliveira AC, Martinez D, Massierer D, Gus M, Goncalves SC, Ghizzoni F, Steinhorst AM, Moreira LB, Fuchs SC, Fuchs FD. The antihypertensive effect of positive airway pressure on resistant hypertension of patients with obstructive sleep apnea: a randomized, double-blind, clinical trial. Am J Respir Crit Care Med. 2014 Aug 1;190(3):345-7. doi: 10.1164/rccm.201403-0479LE. No abstract available.
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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.
Flavio D Fuchs principal investigator
Hospital de Clinicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing active CPAP in people with Hypertension, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
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 2 inclusion and 5 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 25 Feb 2014. 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 Brazil. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Blood pressure evaluated with ambulatory 24-hour blood pressure monitoring (time frame: 8 weeks after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00929175, which also lists 1 linked publication.
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 25 Feb 2014.