HypertensionPhase 2NCT00459914
Sleep Apnea and Refractory Hypertension: Prevalence and Effect of CPAP Treatment
A Phase 2 study testing cpap treatment during sleep in people with Hypertension and Sleep Apnea, run by Fundacio Catalana de Pneumologia at 1 site in Spain.
Trial summary
A small number of uncontrolled studies have shown a high prevalence of sleep apnea in patients with refractory hypertension and that CPAP treatment achieves a significant reduction of blood pressure in the short term. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypertension, Sleep Apnea
- What is being tested?
- cpap treatment during sleep
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2005to Dec 2008
- Phase
- Phase 2
- 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 referred from a tertiary hospital hypertension clinic with a diagnosis of refractory hypertension on the basis of office blood pressure higher then 160/90 mmHg despite the recommended doses of at least 3 drugs, including a diuretic.
Who cannot join
- Causes of secondary hypertension, history of alcohol abuse , renal insufficiency, severe chronically illness.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Servei de Pneumologia, Hosital general Universitari Vall d'Hebron
Barcelona, Barcelona, 08035
About this study
Official title: Sleep Apnea in Patients With Refractory Hypertension: Study of the Prevalence and the Effect of CPAP Treatment on Blood Pressure Control, Endothelial Dysfunction and Angiogenesis.
A small number of uncontrolled studies have shown a high prevalence of sleep apnea in patients with refractory hypertension and that CPAP treatment achieves a significant reduction of blood pressure in the short term.
The purpose of this study is to assess the prevalence of sleep apnea in patients with refractory hypertension, and the effects of continuous positive pressure treatment on systemic blood pressure and on serum markers of endothelial dysfunction and angiogenesis.
Read the detailed description
We assess the prevalence of an apnea hypopnea index (AHI) > 5 in patients with refractory hypertension referred from a hypertension clinic. Patients with an AHI >15 are randomized to either continuing their usual pharmacological treatment alone or adding CPAP to their usual treatment, during a 3 month period.
The main endpoint is the comparison of the mean 24h systolic and diastolic blood pressure, as assessed by ambulatory blood pressure monitoring, between both treatment arms. The secondary endpoint is to assess changes in serum markers of endothelial dysfunction and angiogenesis
- Conditions
- Hypertension, Sleep Apnea
- Being tested
- cpap treatment during sleep
- Keywords
- sleep apnea, refractory hypertension, continuous positive airway pressure
- 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.
cpap treatment during sleepDevice
CPAP
| Study group | Role | What they receive |
|---|---|---|
| 1 CPAP | Active comparator | Nasal continuous positive airway pressure Receives: Device: cpap treatment during sleep |
| 2 | No intervention | Pharmacological treatment alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of 3 months of CPAP versus conventional pharmacological treatment on the mean 24 h systolic and diastolic blood pressure .
Measured: 3 months
Secondary outcomes (1)
Effect of CPAP versus conventional pharmacological treatment on inflammatory, endothelial function and angiogenesis serum biomarkers
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2007 (estimated)
- Study startJan 2005
- Primary completionMay 2008
- Study completionDec 2008
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.
- 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacio Catalana de Pneumologia
- Sponsor type
- University, hospital or other
- Investigators
- Lourdes Lozano, MD, Principal investigator, Hospital General Universitari Vall d'HebronJose Luis Tovar, MD, Study chair, Hospital General Universitari Vall d'HebronGabriel Sampol, MD, Study chair, Hospital General Universitari Vall d'HebronOdile Romero, MD, Study chair, Hospital General Universitari Vall d'HebronPilar Chacon, MD, Study chair, Hospital General Universitari Vall d'HebronJose Rios, Study chair, Universitat Autonoma de Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00459914
- Sponsor's protocol ID
- FUCAP2004
- Status last verified
- Jan 2009
- First submitted
- 11 Apr 2007
- Last updated
- 29 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Apnea in Patients With Refractory Hypertension: Study of the Prevalence and the Effect of CPAP Treatment on Blood Pressure Control, Endothelial Dysfunction and Angiogenesis.
- ClinicalTrials.gov ID
- NCT00459914
- Acronym / sponsor ID
- FUCAP2004
- Conditions
- Hypertension, Sleep Apnea
- Keywords
- sleep apnea, refractory hypertension, continuous positive airway pressure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Fundacio Catalana de PneumologiaUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- May 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 13 Apr 2007 (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.
A small number of uncontrolled studies have shown a high prevalence of sleep apnea in patients with refractory hypertension and that CPAP treatment achieves a significant reduction of blood pressure in the short term.
The purpose of this study is to assess the prevalence of sleep apnea in patients with refractory hypertension, and the effects of continuous positive pressure treatment on systemic blood pressure and on serum markers of endothelial dysfunction and angiogenesis.
Detailed description
We assess the prevalence of an apnea hypopnea index (AHI) > 5 in patients with refractory hypertension referred from a hypertension clinic. Patients with an AHI >15 are randomized to either continuing their usual pharmacological treatment alone or adding CPAP to their usual treatment, during a 3 month period.
The main endpoint is the comparison of the mean 24h systolic and diastolic blood pressure, as assessed by ambulatory blood pressure monitoring, between both treatment arms. The secondary endpoint is to assess changes in serum markers of endothelial dysfunction and angiogenesis
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 CPAP | Active comparator | Device: cpap treatment during sleepNasal continuous positive airway pressure |
| 2 | No intervention | –Pharmacological treatment alone |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients referred from a tertiary hospital hypertension clinic with a diagnosis of refractory hypertension on the basis of office blood pressure higher then 160/90 mmHg despite the recommended doses of at least 3 drugs, including a diuretic.
Key exclusion criteria (1 listed)
- Causes of secondary hypertension, history of alcohol abuse , renal insufficiency, severe chronically illness.
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 |
|---|---|---|
| cpap treatment during sleepCPAP | Device | 1 CPAP |
Primary outcome
Effect of 3 months of CPAP versus conventional pharmacological treatment on the mean 24 h systolic and diastolic blood pressure .
Time frame: 3 months
1 secondary outcome
Effect of CPAP versus conventional pharmacological treatment on inflammatory, endothelial function and angiogenesis serum biomarkers
Time frame: 3 months
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 Jan 2009.
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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.
Lourdes Lozano, MD principal investigator
Hospital General Universitari Vall d'Hebron
Jose Luis Tovar, MD study chair
Hospital General Universitari Vall d'Hebron
Gabriel Sampol, MD study chair
Hospital General Universitari Vall d'Hebron
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing cpap treatment during sleep in people with Hypertension and Sleep Apnea, run by Fundacio Catalana de Pneumologia 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 1 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 29 Jan 2009. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Effect of 3 months of CPAP versus conventional pharmacological treatment on the mean 24 h systolic and diastolic blood pressure . (time frame: 3 months). 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 29 Jan 2009.