HypertensionPhase 3DOSA-2NCT02896621
Effect of Antihypertensive Agents on Diastolic Function in Patients With Sleep Apnea
A Phase 3 study testing Chlorthalidone plus amiloride and Amlodipine in people with Hypertension and Sleep Apnea, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
The investigators investigated diastolic function among patients with obstructive sleep apnea (OSA) and hypertension stage I. In this randomized controlled trial, participants were randomly allocated to one of two groups: chlorthalidone associated with amiloride or amlodipine. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Hypertension, Sleep Apnea
- What is being tested?
- Chlorthalidone plus amiloride and Amlodipine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteBrazil
- Study dates
- 7 Dec 2014to 14 Feb 2017
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 40 to 70 years
- Stage I hypertension (systolic BP: 140-159 or diastolic BP: 90-99 mmHg)
- No antihypertensive treatment or use of one antihypertensive drug
- Apnea / hypopnea index: 10 to 49 AH / hour
Who cannot join
- Low life expectancy
- Indication for use of calcium channel blockers or diuretics
- Allergy medications study
- Heart failure
- Myocardial infarction
- Recent stroke (last 3 months)
Show all 9Show fewer
- Secondary hypertension
- Participation in another clinical trial (last 6 months)
- Pregnant women
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: Effect of Antihypertensive Agents on Diastolic Function in Patients With Sleep Apnea: Protocol for a Randomized Controlled Trial
The investigators investigated diastolic function among patients with obstructive sleep apnea (OSA) and hypertension stage I. In this randomized controlled trial, participants were randomly allocated to one of two groups: chlorthalidone associated with amiloride or amlodipine. Randomization was carried out prior to the start of the trial by an epidemiologist out of clinic and the randomization list was stratified by gender and severity of OSA. The research team and participants were blinded to the randomization list and allocation concealment was implemented. This trial aimed to detect changes in the echocardiography parameters with the drug treatment (higher in the intervention than in the placebo group). The investigators also assess change in daytime sleepiness among participants who already have been diagnosed with OSA.
Read the detailed description
This is a randomized controlled trial, with participants randomly allocated to one of two groups: chlorthalidone associated with amiloride or amlodipine. Capsules were identical presentation and the research team and participants were blinded to the allocation list. The randomization list was stratified by gender and severity of OSA (AHI: 10-25 or 26-40) and in blocks in time, with size four and six units. Randomization was carried out prior to the start of the trial and it was generated by a validated software (Random Allocator). In order to ensure the confidentiality of the allocation list, it was generated by an epidemiologist who did not maintain direct contact with participants and the identification of the study drugs was done through alphanumeric code, implemented via software (RedCap).
Adherence to treatment was measured by counting returned capsules and through the Morisky questionnaire with eight questions, validated for Portuguese. Participants underwent initial clinical evaluation prior to randomization and after eight weeks of treatment for evaluation of outcomes. Demographic characteristics (age, gender, skin color), socioeconomic level (education), previous morbidity (diabetes mellitus, stroke, acute myocardial infarction, cancer, rheumatic diseases), treatments in use (anti-diabetic, anti-depressants, non-steroidal anti-inflammatory, corticosteroids, nasal vasoconstrictor, appetite suppressants, lipid-lowering drugs) and lifestyle characteristics (smoking and drinking) were collected in a standardized way. The investigators also assess anthropometric measures such as weight, height, waist, neck and hip circumference, and bioimpedance for determination of lean and fat mass. Blood pressure was measured using a validated digital oscillometric monitor, with cuff appropriate to the arm circumference, and two measurements per visit were made. In addition, ECG was performed and biochemical parameters (creatinine, blood glucose, serum potassium, uric acid, cholesterol and fractions, C-reactive protein and NT-proBNP) were determined in the laboratory of Hospital de Clinicas de Porto Alegre.
The transthoracic echocardiography is performed by the CX-50 unit (Philips, Bothell, WA - USA) with sectoral S5-1 transducer. Ambulatory monitoring of blood pressure will be measured through the Mortara AMBULO 2400 device (Mortara, Milwaukee, WI, USA) with measures 15/15 minutes during the day and 20/20 minutes at night, within 24 hours of a working day. Polysomnography will be held in type III (home with device that measures at least 4 cardiorespiratory variables) held with handset Sonmocheck (Weinmann GmbH, Hamburg, Germany), a monitor that detects the position of the patient, the presence of apneas or hypopneas, heart rate and digital oximetry.
- Conditions
- Hypertension, Sleep Apnea
- Being tested
- Chlorthalidone plus amiloride, Amlodipine
- Keywords
- Sleep Apnea, Hypertension, Chlortalidone, Diastolic function
- 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.
Chlorthalidone plus amilorideDrug
Also called Chlo+Ami
A capsule with chlorthalidone plus amiloride was taken once daily in the morning for eight weeks.
AmlodipineDrug
Also called Amlo
A capsule of amlodipine was taken once daily in the morning for eight weeks.
| Study group | Role | What they receive |
|---|---|---|
| Chlorthalidone plus amiloride | Experimental | Chlorthalidone plus amiloride group received 25 mg of chlortalidone and amiloride, 5 mg.
A capsule with both drugs was taken once daily in the morning for eight weeks. Receives: Drug: Chlorthalidone plus amiloride |
| Amlodipine | Active comparator | Amlodipine group received 10 mg. A capsule was taken once daily in the morning for eight weeks. Capsules of amlodipine had identical presentation of that the intervention drug. Receives: Drug: Amlodipine |
What is being measured
The primary outcome is the main question the study is designed to answer.
E/A ratio
E/A (mitral inflow indices) echocardiography
Measured: Change at eight weeks (end of the trial)
Secondary outcomes (1)
Daytime sleepiness
Increase in quality of life sleep-related (Functional Outcomes of Sleep Questionnaire; FOSQ-10) or reduction in daytime sleepiness (Epworth Sleepiness Scale)
Measured: Change at eight weeks (end of the trial)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2016 (estimated)
- Study start7 Dec 2014
- Primary completion23 Feb 2016
- Study completion14 Feb 2017
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.
- 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
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sandra C Fuchs, MD, PhD, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02896621
- Sponsor's protocol ID
- 45007115.0.0000.5327
- Other IDs
- GPPG: 150274
- Acronym
- DOSA-2
- Status last verified
- Jun 2018
- First submitted
- 15 Jul 2016
- Last updated
- 14 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Antihypertensive Agents on Diastolic Function in Patients With Sleep Apnea: Protocol for a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02896621
- Acronym / sponsor ID
- DOSA-2 / 45007115.0.0000.5327
- Conditions
- Hypertension, Sleep Apnea
- Keywords
- Sleep Apnea, Hypertension, Chlortalidone, Diastolic function
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- 7 Dec 2014 (actual)
- Primary completion
- 23 Feb 2016 (actual)
- Study completion
- 14 Feb 2017 (actual)
- First posted
- 12 Sep 2016 (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 investigators investigated diastolic function among patients with obstructive sleep apnea (OSA) and hypertension stage I. In this randomized controlled trial, participants were randomly allocated to one of two groups: chlorthalidone associated with amiloride or amlodipine. Randomization was carried out prior to the start of the trial by an epidemiologist out of clinic and the randomization list was stratified by gender and severity of OSA. The research team and participants were blinded to the randomization list and allocation concealment was implemented. This trial aimed to detect changes in the echocardiography parameters with the drug treatment (higher in the intervention than in the placebo group). The investigators also assess change in daytime sleepiness among participants who already have been diagnosed with OSA.
Detailed description
This is a randomized controlled trial, with participants randomly allocated to one of two groups: chlorthalidone associated with amiloride or amlodipine. Capsules were identical presentation and the research team and participants were blinded to the allocation list. The randomization list was stratified by gender and severity of OSA (AHI: 10-25 or 26-40) and in blocks in time, with size four and six units. Randomization was carried out prior to the start of the trial and it was generated by a validated software (Random Allocator). In order to ensure the confidentiality of the allocation list, it was generated by an epidemiologist who did not maintain direct contact with participants and the identification of the study drugs was done through alphanumeric code, implemented via software (RedCap).
Adherence to treatment was measured by counting returned capsules and through the Morisky questionnaire with eight questions, validated for Portuguese. Participants underwent initial clinical evaluation prior to randomization and after eight weeks of treatment for evaluation of outcomes. Demographic characteristics (age, gender, skin color), socioeconomic level (education), previous morbidity (diabetes mellitus, stroke, acute myocardial infarction, cancer, rheumatic diseases), treatments in use (anti-diabetic, anti-depressants, non-steroidal anti-inflammatory, corticosteroids, nasal vasoconstrictor, appetite suppressants, lipid-lowering drugs) and lifestyle characteristics (smoking and drinking) were collected in a standardized way. The investigators also assess anthropometric measures such as weight, height, waist, neck and hip circumference, and bioimpedance for determination of lean and fat mass. Blood pressure was measured using a validated digital oscillometric monitor, with cuff appropriate to the arm circumference, and two measurements per visit were made. In addition, ECG was performed and biochemical parameters (creatinine, blood glucose, serum potassium, uric acid, cholesterol and fractions, C-reactive protein and NT-proBNP) were determined in the laboratory of Hospital de Clinicas de Porto Alegre.
The transthoracic echocardiography is performed by the CX-50 unit (Philips, Bothell, WA - USA) with sectoral S5-1 transducer. Ambulatory monitoring of blood pressure will be measured through the Mortara AMBULO 2400 device (Mortara, Milwaukee, WI, USA) with measures 15/15 minutes during the day and 20/20 minutes at night, within 24 hours of a working day. Polysomnography will be held in type III (home with device that measures at least 4 cardiorespiratory variables) held with handset Sonmocheck (Weinmann GmbH, Hamburg, Germany), a monitor that detects the position of the patient, the presence of apneas or hypopneas, heart rate and digital oximetry.
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 |
|---|---|---|
| Chlorthalidone plus amiloride | Experimental | Drug: Chlorthalidone plus amilorideChlorthalidone plus amiloride group received 25 mg of chlortalidone and amiloride, 5 mg. A capsule with both drugs was taken once daily in the morning for eight weeks. |
| Amlodipine | Active comparator | Drug: AmlodipineAmlodipine group received 10 mg. A capsule was taken once daily in the morning for eight weeks. Capsules of amlodipine had identical presentation of that the intervention drug. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 40 to 70 years
- Stage I hypertension (systolic BP: 140-159 or diastolic BP: 90-99 mmHg)
- No antihypertensive treatment or use of one antihypertensive drug
- Apnea / hypopnea index: 10 to 49 AH / hour
Key exclusion criteria (9 listed)
- Low life expectancy
- Indication for use of calcium channel blockers or diuretics
- Allergy medications study
- Heart failure
- Myocardial infarction
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 |
|---|---|---|
| Chlorthalidone plus amilorideAlso: Chlo+AmiA capsule with chlorthalidone plus amiloride was taken once daily in the morning for eight weeks. | Drug | Chlorthalidone plus amiloride |
| AmlodipineAlso: AmloA capsule of amlodipine was taken once daily in the morning for eight weeks. | Drug | Amlodipine |
Primary outcome
E/A ratio
Time frame: Change at eight weeks (end of the trial)
E/A (mitral inflow indices) echocardiography
1 secondary outcome
Daytime sleepiness
Time frame: Change at eight weeks (end of the trial)
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 Jun 2018.
- 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.
Sandra C Fuchs, MD, PhD 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 3 study testing Chlorthalidone plus amiloride and Amlodipine in people with Hypertension and 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 4 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 Jun 2018. 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?
E/A ratio (time frame: Change at eight weeks (end of the trial)). 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 14 Jun 2018.