Sleep ApneaNCT00616265
Effect of Continuous Positive Airway Pressure (CPAP) Treatment in the Control of Refractory Hypertension
A study testing CPAP in people with Sleep Apnea and Hypertension, run by Sociedad Española de Neumología y Cirugía Torácica at 1 site in Spain.
Trial summary
The working hypothesis for the present study is that treatment with CPAP in patients with an sleep apnea (IAH>15) and AHT-r is capable of producing significant reductions in blood-pressure levels. This hypothesis is supported by four proven findings: 1. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Sleep Apnea, Hypertension
- What is being tested?
- CPAP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2008to Feb 2012
- Phase
- Interventional
- 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
Who may be able to join
- Patients aged 18-75 with a diagnosis of primary AHT-r and an AHI ≥15.
- Signature indicating informed consent.
Who cannot join
- Those patients with, in the opinion of the researcher, incapacitating hypersomnia will be excluded (to avoid the ethical problems associated with not treating a symptomatic sleep apnea patient).
- Patients with risky professions or work involving dangerous goods.
- Pregnancy.
- The regular use of psychotropic drugs that could significantly modify the results of the sleep studies, or previous alcoholism (more than 100 gr of alcohol/day).
- Patients previously treated with CPAP.
- Record of poor compliance with anti-hypertensive treatment.
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- AHT secondary to cardiac insufficiency, valvulopathy, renal or endocrinological causes, cor pulmonale or the consumption of oral corticoids, or any other known cause.
- Patients who have suffered from a cardiovascular event in the month prior to inclusion in the study, or patients who were unstable at the time of their inclusion in the study.
- Known renal insufficiency with a concentration of creatinine greater than 1.5 mg/dl
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of CPAP Treatment in the Control of Refractory Hypertension
The working hypothesis for the present study is that treatment with CPAP in patients with an sleep apnea (IAH>15) and AHT-r is capable of producing significant reductions in blood-pressure levels.
This hypothesis is supported by four proven findings:
Read more
- -sleep apnea is an independent risk factor for arterial hypertension (1).
- -The greater the number of RSD, the greater the loss of control over blood-pressure levels (1).
- -The prevalence of sleep apnea in patients with AHT refractory to treatment is very high (11,12).
- -Treatment of patients with sleep apnea and AHT-r with CPAP succeeds in significantly reducing blood-pressure levels in the only (small-scale) studies undertaken to date (14,15).
- OBJECTIVES
Main objective:
To evaluate the effect of treatment with CPAP on blood-pressure levels in patients with AHT refractory to medical treatment.
Secondary objectives:
- To evaluate the effect of treatment with CPAP on the various elements assessed in BP (systolic/diastolic; daytime/nighttime, etc) and the circadian profile (dipper/non-dipper/raiser patterns; variability and homogeneity of blood-pressure levels, etc) obtained during a 24-hour out-patient study (AMPA).
- To analyze the related variables or subgroups of patients most affected by treatment with CPAP.
- To evaluate the effect of CPAP on the levels of some of the biological variables involved in the pathogenesis of AHT-r (renin, angiotensin, aldosterone, atrial natriuretic factor, etc).
Read the detailed description
OBJECTIVE. To evaluate the effect of continuous positive airway pressure (CPAP) treatment on the blood-pressure (BP) levels of patients with refractory arterial hypertension (AHT-r).
METHODS: Multicenter randomized study with parallel groups and blind final evaluation.
Patients will be recruited from AHT, nephrology or internal medicine outpatient clinics and will satisfy the criteria for AHT-r (patients requiring 3 anti-AHT drugs at recommended doses to maintain their blood-pressure levels within AMPA [24-hours ambulatory monitoring of blood pressure values) excluding those forms of secondary AHT and those patients with incapacitating hypersomnia that need immediate treatment. In all, 210 patients will be included (105 per arm for intention to treat analysis) in accordance with the calculation of the sample size needed including drop-outs to evaluate a clinically significant minimum drop of 4-5 mmHg in the mean BP and the number of centers (21 centers; 10 patients per center). They will all be subjected to a complete clinical history, an AMPA study, a blood test (with serum retained for a later determination of biological mediators) and a sleep study. Those patients with an AHI>15 will be randomized to receive CPAP vs habitual control. The treatment will last 3 months. The same variables that were measured before the randomization will be analyzed again for the purposes of comparison. The comparison of results will be undertaken on the basis of an intention-to-treat and per-protocol analyses based on adherence to CPAP treatment at different cutoff of hours /day by means of an ANOVA two-way analysis (one of them being time).
- Conditions
- Sleep Apnea, Hypertension
- Being tested
- CPAP
- Keywords
- Sleep apnea, Refractory Hypertension, Difficult-to-treat hypertension, CPAP
- Medical subject headings
- Sleep Apnea Syndromes, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAPDevice
Also called Continuous positive airway pressure
Pressure device on airway to maintain it open
| Study group | Role | What they receive |
|---|---|---|
| B | No intervention | Group B. Only Usual Control |
| A | Experimental | Group A: Cpap treatment plus Usual control Receives: Device: CPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect on blood pressure levels
Measured: Before and six months after CPAP treatment
Secondary outcomes (1)
Effect on night blood pressure pattern
Measured: Befor and six month after CPAP treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2008 (estimated)
- Study startJun 2008
- Primary completionDec 2011
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sleep ApneaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sociedad Española de Neumología y Cirugía Torácica
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miguel angel Martinez Garcia, Sociedad Española de Neumología y Cirugía Torácica
- Investigators
- Miguel Angel Martínez-Garcia, MD, Principal investigator, Sociedad Española de Neumología y Cirugía Torácica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00616265
- Sponsor's protocol ID
- Prot-740
- Other IDs
- Prot-740 SEPAR, SEPAR-90
- Status last verified
- Feb 2012
- First submitted
- 4 Feb 2008
- Last updated
- 29 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sanchez-de-la-Torre M, Khalyfa A, Sanchez-de-la-Torre A, Martinez-Alonso M, Martinez-Garcia MA, Barcelo A, Lloberes P, Campos-Rodriguez F, Capote F, Diaz-de-Atauri MJ, Somoza M, Gonzalez M, Masa JF, Gozal D, Barbe F; Spanish Sleep Network. Precision Medicine in Patients With Resistant Hypertension and Obstructive Sleep Apnea: Blood Pressure Response to Continuous Positive Airway Pressure Treatment. J Am Coll Cardiol. 2015 Sep 1;66(9):1023-32. doi: 10.1016/j.jacc.2015.06.1315.
PubMed 26314530Martinez-Garcia MA, Capote F, Campos-Rodriguez F, Lloberes P, Diaz de Atauri MJ, Somoza M, Masa JF, Gonzalez M, Sacristan L, Barbe F, Duran-Cantolla J, Aizpuru F, Manas E, Barreiro B, Mosteiro M, Cebrian JJ, de la Pena M, Garcia-Rio F, Maimo A, Zapater J, Hernandez C, Grau SanMarti N, Montserrat JM; Spanish Sleep Network. Effect of CPAP on blood pressure in patients with obstructive sleep apnea and resistant hypertension: the HIPARCO randomized clinical trial. JAMA. 2013 Dec 11;310(22):2407-15. doi: 10.1001/jama.2013.281250.
PubMed 24327037
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of CPAP Treatment in the Control of Refractory Hypertension
- ClinicalTrials.gov ID
- NCT00616265
- Acronym / sponsor ID
- Prot-740
- Conditions
- Sleep Apnea, Hypertension
- Keywords
- Sleep apnea, Refractory Hypertension, Difficult-to-treat hypertension, CPAP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Sociedad Española de Neumología y Cirugía TorácicaUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Dec 2011 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 15 Feb 2008 (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.
The working hypothesis for the present study is that treatment with CPAP in patients with an sleep apnea (IAH>15) and AHT-r is capable of producing significant reductions in blood-pressure levels.
This hypothesis is supported by four proven findings:
- -sleep apnea is an independent risk factor for arterial hypertension (1).
- -The greater the number of RSD, the greater the loss of control over blood-pressure levels (1).
- -The prevalence of sleep apnea in patients with AHT refractory to treatment is very high (11,12).
- -Treatment of patients with sleep apnea and AHT-r with CPAP succeeds in significantly reducing blood-pressure levels in the only (small-scale) studies undertaken to date (14,15).
- OBJECTIVES
Main objective:
To evaluate the effect of treatment with CPAP on blood-pressure levels in patients with AHT refractory to medical treatment.
Secondary objectives:
- To evaluate the effect of treatment with CPAP on the various elements assessed in BP (systolic/diastolic; daytime/nighttime, etc) and the circadian profile (dipper/non-dipper/raiser patterns; variability and homogeneity of blood-pressure levels, etc) obtained during a 24-hour out-patient study (AMPA).
- To analyze the related variables or subgroups of patients most affected by treatment with CPAP.
- To evaluate the effect of CPAP on the levels of some of the biological variables involved in the pathogenesis of AHT-r (renin, angiotensin, aldosterone, atrial natriuretic factor, etc).
Detailed description
OBJECTIVE. To evaluate the effect of continuous positive airway pressure (CPAP) treatment on the blood-pressure (BP) levels of patients with refractory arterial hypertension (AHT-r).
METHODS: Multicenter randomized study with parallel groups and blind final evaluation.
Patients will be recruited from AHT, nephrology or internal medicine outpatient clinics and will satisfy the criteria for AHT-r (patients requiring 3 anti-AHT drugs at recommended doses to maintain their blood-pressure levels within AMPA [24-hours ambulatory monitoring of blood pressure values) excluding those forms of secondary AHT and those patients with incapacitating hypersomnia that need immediate treatment. In all, 210 patients will be included (105 per arm for intention to treat analysis) in accordance with the calculation of the sample size needed including drop-outs to evaluate a clinically significant minimum drop of 4-5 mmHg in the mean BP and the number of centers (21 centers; 10 patients per center). They will all be subjected to a complete clinical history, an AMPA study, a blood test (with serum retained for a later determination of biological mediators) and a sleep study. Those patients with an AHI>15 will be randomized to receive CPAP vs habitual control. The treatment will last 3 months. The same variables that were measured before the randomization will be analyzed again for the purposes of comparison. The comparison of results will be undertaken on the basis of an intention-to-treat and per-protocol analyses based on adherence to CPAP treatment at different cutoff of hours /day by means of an ANOVA two-way analysis (one of them being time).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| B | No intervention | –Group B. Only Usual Control |
| A | Experimental | Device: CPAPGroup A: Cpap treatment plus Usual control |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged 18-75 with a diagnosis of primary AHT-r and an AHI ≥15.
- Signature indicating informed consent.
Key exclusion criteria (9 listed)
- Those patients with, in the opinion of the researcher, incapacitating hypersomnia will be excluded (to avoid the ethical problems associated with not treating a symptomatic sleep apnea patient).
- Patients with risky professions or work involving dangerous goods.
- Pregnancy.
- The regular use of psychotropic drugs that could significantly modify the results of the sleep studies, or previous alcoholism (more than 100 gr of alcohol/day).
- Patients previously 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPAPAlso: Continuous positive airway pressurePressure device on airway to maintain it open | Device | A |
Primary outcome
Effect on blood pressure levels
Time frame: Before and six months after CPAP treatment
1 secondary outcome
Effect on night blood pressure pattern
Time frame: Befor and six month after CPAP treatment
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 29 Feb 2012.
- Derived from this study: PubMed 26314530Sanchez-de-la-Torre M, Khalyfa A, Sanchez-de-la-Torre A, Martinez-Alonso M, Martinez-Garcia MA, Barcelo A, Lloberes P, Campos-Rodriguez F, Capote F, Diaz-de-Atauri MJ, Somoza M, Gonzalez M, Masa JF, Gozal D, Barbe F; Spanish Sleep Network. Precision Medicine in Patients With Resistant Hypertension and Obstructive Sleep Apnea: Blood Pressure Response to Continuous Positive Airway Pressure Treatment. J Am Coll Cardiol. 2015 Sep 1;66(9):1023-32. doi: 10.1016/j.jacc.2015.06.1315.
- Derived from this study: PubMed 24327037Martinez-Garcia MA, Capote F, Campos-Rodriguez F, Lloberes P, Diaz de Atauri MJ, Somoza M, Masa JF, Gonzalez M, Sacristan L, Barbe F, Duran-Cantolla J, Aizpuru F, Manas E, Barreiro B, Mosteiro M, Cebrian JJ, de la Pena M, Garcia-Rio F, Maimo A, Zapater J, Hernandez C, Grau SanMarti N, Montserrat JM; Spanish Sleep Network. Effect of CPAP on blood pressure in patients with obstructive sleep apnea and resistant hypertension: the HIPARCO randomized clinical trial. JAMA. 2013 Dec 11;310(22):2407-15. doi: 10.1001/jama.2013.281250.
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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.
Miguel Angel Martínez-Garcia, MD principal investigator
Sociedad Española de Neumología y Cirugía Torácica
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPAP in people with Sleep Apnea and Hypertension, run by Sociedad Española de Neumología y Cirugía Torácica at 1 site in Spain.
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 9 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 29 Feb 2012. 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 Spain. 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?
Effect on blood pressure levels (time frame: Before and six months after CPAP 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 NCT00616265, which also lists 2 linked publications.
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 29 Feb 2012.