HypertensionPhase 3NCT01896661
Effect of Antihypertensive Agents Over Sleep Apnea
A Phase 3 study testing Diuretics and Calcium Channel Blockers in people with Hypertension and Obstructive Sleep Apnea, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
Obstructive sleep apnea and hypertension are well-known cardiovascular risk factors. Their control could reduce the burden of heart disease across populations. There are several drugs to control hypertension, but the only consistently beneficial treatment to reduce apneas is continuous positive airway pressure. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Hypertension, Obstructive Sleep Apnea
- What is being tested?
- Diuretics and Calcium Channel Blockers
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteBrazil
- Study dates
- Dec 2014to Feb 2016
- Phase
- Phase 3
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients older than 40 years of age
- Stage I hypertension (140-159/90-99 mmHg) and moderate obstructive sleep apnea (10-40 apneas/hour of sleep)
Who cannot join
- Low life expectancy
- Other indications for the use of diuretics or calcium channel blocker -Intolerance or contraindications to the study drugs
- Pregnancy
- Established cardiovascular disease (myocardial infarction
- Stroke
- Heart failure)
Show all 9Show fewer
- Use of more than one drug for hypertension
- Secondary hypertension
- Participation in other clinical trial in previous 6 months
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903
About this study
Official title: The Effect of Antihypertensive Agents Over Sleep Apnea: a Randomized Controlled Trial
Obstructive sleep apnea and hypertension are well-known cardiovascular risk factors. Their control could reduce the burden of heart disease across populations. There are several drugs to control hypertension, but the only consistently beneficial treatment to reduce apneas is continuous positive airway pressure. The demonstration that one drug could improve sleep apnea and hypertension would support a novel approach in the treatment of both diseases. The role of fluid retention in sleep apnea is known for several decades. The role of diuretics is well established in hypertension but was never appropriately tested in sleep apnea. Besides to test the efficacy of these drugs, this study will help to understand the mechanisms that link hypertension and sleep apnea and its treatment.
Read the detailed description
This is a randomized, double-blind, clinical trial, comparing the association of Chlorthalidone plus amiloride 25 and 5 mg daily, versus amlodipine 10 mg daily as first drug option in patients older than 40 years of age with Stage I hypertension (140-159/90-99 mmHg) and moderate obstructive sleep apnea (15-30 apneas/hour of sleep). The primary outcomes will be the variation of apneas/hour and blood pressure. The secondary outcomes will be adverse events, somnolence scale (Epworth), ventilatory parameters and C reactive protein. The follow up will last 8 weeks. The sample size will be of 29 participants per group. The project was approved by the Ethics committee of our institution.
- Conditions
- Hypertension, Obstructive Sleep Apnea
- Being tested
- Diuretics, Calcium Channel Blockers
- Keywords
- Sleep apnea, Hypertension, Treatment, Diuretics, Chlorthalidone, Amlodipine
- Medical subject headings
- Hypertension, Sleep Apnea, Obstructive, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiureticsDrug
Also called Chlorthalidone/Amiloride
Chlorthalidone plus amiloride 25 and 5 mg daily, taking in the morning
Calcium Channel BlockersDrug
Also called Amlodipine
Amlodipine 10 mg daily, taking in the morning
| Study group | Role | What they receive |
|---|---|---|
| Diuretics | Experimental | Chlorthalidone plus amiloride 25 and 5 mg daily, taking in the morning Receives: Drug: Diuretics |
| Calcium Channel Blockers | Active comparator | Amlodipine 10 mg daily, taking in the morning Receives: Drug: Calcium Channel Blockers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea-Hypopnea Index
Number of apneas/hour
Measured: 8 weeks
Blood Pressure
Measured: 8 weeks
Secondary outcomes (3)
Adverse events
Measured: 8 weeks
Somnolence scale (Epworth) and ventilatory parameters
Measured: 8 weeks
C reactive protein
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 posted11 Jul 2013 (estimated)
- Study startDec 2014
- Primary completionDec 2015
- Study completionFeb 2016
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 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 53 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, MD, PhD, Study chair, Hospital de Clinicas de Porto Alegre, Universidade Federal do Rio Grande do SulFabio T Cichelero, MD, Principal investigator, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01896661
- Sponsor's protocol ID
- 07572112.7.0000.5327
- Other IDs
- 12-0417
- Status last verified
- Jul 2016
- First submitted
- 8 Jul 2013
- Last updated
- 14 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Cichelero FT, Fuchs SC, Jorge JA, Martinez D, Oliveira GPF, Lucca MB, Oliveira ACT, Fuchs FD. Effect of antihypertensive agents on sleep apnea and ambulatory blood pressure in patients with hypertension: A randomized controlled trial. Sleep Med. 2024 Jul;119:417-423. doi: 10.1016/j.sleep.2024.05.035. Epub 2024 May 16.
PubMed 38781664Cichelero FT, Martinez D, Fuchs SC, Gus M, Moreira LB, Fuchs FD. The effect of antihypertensive agents on sleep apnea: protocol for a randomized controlled trial. Trials. 2014 Jan 2;15:1. doi: 10.1186/1745-6215-15-1.
PubMed 24382030
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Antihypertensive Agents Over Sleep Apnea: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01896661
- Acronym / sponsor ID
- 07572112.7.0000.5327
- Conditions
- Hypertension, Obstructive Sleep Apnea
- Keywords
- Sleep apnea, Hypertension, Treatment, Diuretics, Chlorthalidone, Amlodipine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 11 Jul 2013 (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 and hypertension are well-known cardiovascular risk factors. Their control could reduce the burden of heart disease across populations. There are several drugs to control hypertension, but the only consistently beneficial treatment to reduce apneas is continuous positive airway pressure. The demonstration that one drug could improve sleep apnea and hypertension would support a novel approach in the treatment of both diseases. The role of fluid retention in sleep apnea is known for several decades. The role of diuretics is well established in hypertension but was never appropriately tested in sleep apnea. Besides to test the efficacy of these drugs, this study will help to understand the mechanisms that link hypertension and sleep apnea and its treatment.
Detailed description
This is a randomized, double-blind, clinical trial, comparing the association of Chlorthalidone plus amiloride 25 and 5 mg daily, versus amlodipine 10 mg daily as first drug option in patients older than 40 years of age with Stage I hypertension (140-159/90-99 mmHg) and moderate obstructive sleep apnea (15-30 apneas/hour of sleep). The primary outcomes will be the variation of apneas/hour and blood pressure. The secondary outcomes will be adverse events, somnolence scale (Epworth), ventilatory parameters and C reactive protein. The follow up will last 8 weeks. The sample size will be of 29 participants per group. The project was approved by the Ethics committee of our institution.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diuretics | Experimental | Drug: DiureticsChlorthalidone plus amiloride 25 and 5 mg daily, taking in the morning |
| Calcium Channel Blockers | Active comparator | Drug: Calcium Channel BlockersAmlodipine 10 mg daily, taking in the morning |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients older than 40 years of age
- Stage I hypertension (140-159/90-99 mmHg) and moderate obstructive sleep apnea (10-40 apneas/hour of sleep)
Key exclusion criteria (9 listed)
- Low life expectancy
- Other indications for the use of diuretics or calcium channel blocker -Intolerance or contraindications to the study drugs
- Pregnancy
- Established cardiovascular disease (myocardial infarction
- Stroke
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 |
|---|---|---|
| DiureticsAlso: Chlorthalidone/AmilorideChlorthalidone plus amiloride 25 and 5 mg daily, taking in the morning | Drug | Diuretics |
| Calcium Channel BlockersAlso: AmlodipineAmlodipine 10 mg daily, taking in the morning | Drug | Calcium Channel Blockers |
Primary outcome
Apnea-Hypopnea Index
Time frame: 8 weeks
Number of apneas/hour
Blood Pressure
Time frame: 8 weeks
3 secondary outcomes
Adverse events
Time frame: 8 weeks
Somnolence scale (Epworth) and ventilatory parameters
Time frame: 8 weeks
C reactive protein
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 14 Jul 2016.
- Derived from this study: PubMed 38781664Cichelero FT, Fuchs SC, Jorge JA, Martinez D, Oliveira GPF, Lucca MB, Oliveira ACT, Fuchs FD. Effect of antihypertensive agents on sleep apnea and ambulatory blood pressure in patients with hypertension: A randomized controlled trial. Sleep Med. 2024 Jul;119:417-423. doi: 10.1016/j.sleep.2024.05.035. Epub 2024 May 16.
- Derived from this study: PubMed 24382030Cichelero FT, Martinez D, Fuchs SC, Gus M, Moreira LB, Fuchs FD. The effect of antihypertensive agents on sleep apnea: protocol for a randomized controlled trial. Trials. 2014 Jan 2;15:1. doi: 10.1186/1745-6215-15-1.
- Individual participant dataSharing planned: Undecided
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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, MD, PhD study chair
Hospital de Clinicas de Porto Alegre, Universidade Federal do Rio Grande do Sul
Fabio T Cichelero, MD principal investigator
Federal University of Rio Grande do Sul
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Diuretics and Calcium Channel Blockers in people with Hypertension and Obstructive Sleep Apnea, 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 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 14 Jul 2016. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Apnea-Hypopnea Index (time frame: 8 weeks). The study lists 2 primary outcomes in all. 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 NCT01896661, 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 14 Jul 2016.