HypertensionSARAHNCT03002558
Long-term Cardiovascular Outcomes in Patients With RH and OSA With or Without Treatment With CPAP
An observational study of Hypertension, run by Sociedad Española de Neumología y Cirugía Torácica at 1 site in Spain.
Trial summary
Objectives: Main objective: To assess the impact of obstructive sleep apnea (OSA) and its treatment on cardiovascular outcomes (morbidity and mortality) in patients with resistant hypertension (RH). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypertension
- How many people
- 591 participants
- Where
- 1 siteSpain
- Study dates
- 29 Apr 2016to 31 Mar 2023
- How long will I take part?
- 5 Years
- Phase
- Observational
- 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
Study population: Patients with Resistant Hypertension
Who may be able to join
- Patients diagnosed of RH according to the following criteria, which include 2 clinical situations: (i) BP above control in ABPM (24-h BP > 130/80 mmHg),regardless of optimal dose treatment with 3 agents (one must be a diuretic). Other causes of inadequate control must be discarded (poor compliance, drugs). (ii) Controlled BP but treated with no less than 4 medications.
- Patients aged 18 to 75 years old.
- To sign informed consent for the participation in the study.
Who cannot join
- Secondary hypertension to endocrinology causes (pheochromocytoma, Conn disease, Cushing´s Syndrome, hyperparathyroidism), drug treatment (NSAID or cortisone, immunodepressants, EPO), renal artery stenosis, alcohol abuse, aortic coarctation and intracranial tumours.
- Any process, that limits life expectancy to less than one year.
- Previously diagnosed OSA with current active treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-term Cardiovascular Outcomes in Patients With Resistant Hypertension and Obstructive Sleep Apnea With or Without Treatment With Continuous Positive Airway Pressure.
Objectives:
Main objective: To assess the impact of obstructive sleep apnea (OSA) and its treatment on cardiovascular outcomes (morbidity and mortality) in patients with resistant hypertension (RH).
Read more
Secondary objectives: i) to identify the subclinical organ damage profile at baseline and its association with OSA, and to identify if long term blood pressure control and number of antihypertensive drugs needed is different depending on OSA diagnosis and its treatment; ii) to identify epigenetic profiles and clinical, biological and polygraphic variables with a predictive value for cardiovascular outcomes in RH patients with OSA; iii) to validate the HIPARCO-SCORE tool in men in an independent cohort and elaborate a new tool to be used in women; and iv) to perform a cost-effectiveness analysis to evaluate the impact of OSA diagnosis and treatment in patients with RH.
Methodology: Prospective cohort study. 1,371 RH patients will be recruited. Ambulatory blood pressure monitoring (ABPM), socio-demographic, clinical, OSA-related, biochemical and subclinical organ damage variables and biological samples at baseline will be collected from all the subjects included. A sleep study will be performed in all the subjects at the study inclusion date. Subsequently, the OSA subjects will be managed as per local standard practice. Follow-up variables will be annually collected (including blood samples). On the basis of OSA and its treatment, three cohorts of RH subjects will be defined: control (non-OSA), OSA-treated and OSA nontreated.
Read the detailed description
A minimum follow-up of 5 years has been established. During the follow-up, an annually programmed visit will be carried on to all patients, collecting variables from subjects' interview in the office.The baseline and follow-up variables will be collected using questionnaires.
The variables that will be collected are:
BP variables; Anthropometric variables; Compliance with CPAP in the case of CPAP-treated OSA patients; blood samples extraction; outcomes (heart disease, cerebrovascular disease, kidney disease, vascular disease). All the cardiovascular events will be independently evaluated by two doctors to establish a diagnostic. In case of discordance a third external doctor will assess the case. The date of each event will be recorded.
- Conditions
- Hypertension
- Keywords
- Hypertension, Continuous Positive Airway Pressure, Obstructive Sleep Apnea, Cardiovascular Diseases
- Medical subject headings
- Hypertension, Sleep Apnea, Obstructive, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| control (non-OSA) | Patients without sleep apnoea | |
| OSA-treated | Patients with sleep apnoea who are treated (CPAP, surgery or MAD) | |
| OSA-non treated | Patients with sleep apnoea who are not treated |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation the impact of OSA and its treatment on cardiovascular outcomes
OSA diagnosis shall be established by PSG or PCR. It will be evaluated cardiovascular outcomes (CV death, non-fatal acute myocardial infarction, non-fatal stroke, hospital admission for heart failure and new hospitalization for unstable angina or Transitory Ischemic Attack) before and after of OSA diagnosis and treatment.
Measured: After 5 years of follow-up
Secondary outcomes (5)
Cardiovascular composite: CV death, non-fatal acute myocardial infarction, non-fatal stroke, hospital admission for heart failure and new hospitalization for unstable angina or Transitory Ischemic Attack.
It will be evaluated cardiovascular outcomes at the end of the study. These outcomes will be collected from subjects' interviews at each yearly follow-up visit in the office and from computed medical records.
Measured: After 5 years of follow-up
Identify epigenetic biomarkers signatures with a predictive value of favourable cardiovascular outcome in patients with RH.
Using DNA and RNA samples, it will be performed different analysis at the end of the study, to see if there is any change in genes related to both diseases
Measured: After 5 years of follow-up
Validation the HIPARCO - Score tool in an independent cohort, men with resistant hypertension, OSA and CPAP compliance (≥4h/night)
Analyse mRNA to validate de HIPARCO score
Measured: 2 years
Creation of a predictive tool (like HIPARCO-Score) for women
Identify a plasma miRNA profile that predicts blood pressure response to CPAP treatment.
Measured: 3 years
Cost- Effectiveness analyses between study groups and to compare the cost of health care utilization between two year before and after the starting of the study related to the study groups.
Only direct costs will be considered. Analysis will include an estimation of quality-adjusted life-years (QALYs) gained
Measured: After 5 years of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2016 (estimated)
- Study start29 Apr 2016
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 591 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Sociedad Española de Neumología y Cirugía Torácica
- Sponsor type
- University, hospital or other
- Collaborators
- Fondo de Investigacion Sanitaria, ResMed
- Responsible party
- Principal investigator, Ferran Barbe, Sociedad Española de Neumología y Cirugía Torácica
- Investigators
- Ferran Barbé, Principal investigator, Spanish Respiratory Society (SEPAR)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03002558
- Sponsor's protocol ID
- SARAH-1
- Acronym
- SARAH
- Status last verified
- Nov 2023
- First submitted
- 16 Dec 2016
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Sapina-Beltran E, Benitez ID, Torres G, Fortuna-Gutierrez AM, Ponte Marquez P, Masa JF, Drager LF, Cabrini M, Felez M, Vazquez S, Abad J, Lee C, Garcia-Rio F, Casitas R, Mediano O, Romero Peralta S, Martinez D, Sanchez-de-la-Torre M, Barbe F, Dalmases M. Effect of CPAP treatment on BP in resistant hypertensive patients according to the BP dipping pattern and the presence of nocturnal hypertension. Hypertens Res. 2022 Mar;45(3):436-444. doi: 10.1038/s41440-021-00762-7. Epub 2021 Dec 24.
PubMed 34952953Sapina-Beltran E, Torres G, Benitez I, Fortuna-Gutierrez AM, Marquez PP, Masa JF, Corral-Penafiel J, Drager LF, Cabrini M, Felez M, Vazquez S, Abad J, Lee CH, Aung AT, Garcia-Rio F, Casitas R, Sanchez-de-la-Torre M, Gaeta AM, Barbe F, Dalmases M. Prevalence, Characteristics, and Association of Obstructive Sleep Apnea with Blood Pressure Control in Patients with Resistant Hypertension. Ann Am Thorac Soc. 2019 Nov;16(11):1414-1421. doi: 10.1513/AnnalsATS.201901-053OC.
PubMed 31514508
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Cardiovascular Outcomes in Patients With Resistant Hypertension and Obstructive Sleep Apnea With or Without Treatment With Continuous Positive Airway Pressure.
- ClinicalTrials.gov ID
- NCT03002558
- Acronym / sponsor ID
- SARAH / SARAH-1
- Conditions
- Hypertension
- Keywords
- Hypertension, Continuous Positive Airway Pressure, Obstructive Sleep Apnea, Cardiovascular Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 591 participants (actual)
- Lead sponsor
- Sociedad Española de Neumología y Cirugía TorácicaUniversity, hospital or other
- Collaborators
- Fondo de Investigacion Sanitaria, ResMed
- Study start
- 29 Apr 2016 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 23 Dec 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.
Objectives:
Main objective: To assess the impact of obstructive sleep apnea (OSA) and its treatment on cardiovascular outcomes (morbidity and mortality) in patients with resistant hypertension (RH).
Secondary objectives: i) to identify the subclinical organ damage profile at baseline and its association with OSA, and to identify if long term blood pressure control and number of antihypertensive drugs needed is different depending on OSA diagnosis and its treatment; ii) to identify epigenetic profiles and clinical, biological and polygraphic variables with a predictive value for cardiovascular outcomes in RH patients with OSA; iii) to validate the HIPARCO-SCORE tool in men in an independent cohort and elaborate a new tool to be used in women; and iv) to perform a cost-effectiveness analysis to evaluate the impact of OSA diagnosis and treatment in patients with RH.
Methodology: Prospective cohort study. 1,371 RH patients will be recruited. Ambulatory blood pressure monitoring (ABPM), socio-demographic, clinical, OSA-related, biochemical and subclinical organ damage variables and biological samples at baseline will be collected from all the subjects included. A sleep study will be performed in all the subjects at the study inclusion date. Subsequently, the OSA subjects will be managed as per local standard practice. Follow-up variables will be annually collected (including blood samples). On the basis of OSA and its treatment, three cohorts of RH subjects will be defined: control (non-OSA), OSA-treated and OSA nontreated.
Detailed description
A minimum follow-up of 5 years has been established. During the follow-up, an annually programmed visit will be carried on to all patients, collecting variables from subjects' interview in the office.The baseline and follow-up variables will be collected using questionnaires.
The variables that will be collected are:
BP variables; Anthropometric variables; Compliance with CPAP in the case of CPAP-treated OSA patients; blood samples extraction; outcomes (heart disease, cerebrovascular disease, kidney disease, vascular disease). All the cardiovascular events will be independently evaluated by two doctors to establish a diagnostic. In case of discordance a third external doctor will assess the case. The date of each event will be recorded.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control (non-OSA) | – | –Patients without sleep apnoea |
| OSA-treated | – | –Patients with sleep apnoea who are treated (CPAP, surgery or MAD) |
| OSA-non treated | – | –Patients with sleep apnoea who are not treated |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Resistant Hypertension
Key inclusion criteria (3 listed)
- Patients diagnosed of RH according to the following criteria, which include 2 clinical situations: (i) BP above control in ABPM (24-h BP > 130/80 mmHg),regardless of optimal dose treatment with 3 agents (one must be a diuretic). Other causes of inadequate control must be discarded (poor compliance, drugs). (ii) Controlled BP but treated with no less than 4 medications.
- Patients aged 18 to 75 years old.
- To sign informed consent for the participation in the study.
Key exclusion criteria (3 listed)
- Secondary hypertension to endocrinology causes (pheochromocytoma, Conn disease, Cushing´s Syndrome, hyperparathyroidism), drug treatment (NSAID or cortisone, immunodepressants, EPO), renal artery stenosis, alcohol abuse, aortic coarctation and intracranial tumours.
- Any process, that limits life expectancy to less than one year.
- Previously diagnosed OSA with current active treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluation the impact of OSA and its treatment on cardiovascular outcomes
Time frame: After 5 years of follow-up
OSA diagnosis shall be established by PSG or PCR. It will be evaluated cardiovascular outcomes (CV death, non-fatal acute myocardial infarction, non-fatal stroke, hospital admission for heart failure and new hospitalization for unstable angina or Transitory Ischemic Attack) before and after of OSA diagnosis and treatment.
5 secondary outcomes
Cardiovascular composite: CV death, non-fatal acute myocardial infarction, non-fatal stroke, hospital admission for heart failure and new hospitalization for unstable angina or Transitory Ischemic Attack.
Time frame: After 5 years of follow-up
Identify epigenetic biomarkers signatures with a predictive value of favourable cardiovascular outcome in patients with RH.
Time frame: After 5 years of follow-up
Validation the HIPARCO - Score tool in an independent cohort, men with resistant hypertension, OSA and CPAP compliance (≥4h/night)
Time frame: 2 years
Creation of a predictive tool (like HIPARCO-Score) for women
Time frame: 3 years
Cost- Effectiveness analyses between study groups and to compare the cost of health care utilization between two year before and after the starting of the study related to the study groups.
Time frame: After 5 years of follow-up
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 22 Nov 2023.
- Derived from this study: PubMed 34952953Sapina-Beltran E, Benitez ID, Torres G, Fortuna-Gutierrez AM, Ponte Marquez P, Masa JF, Drager LF, Cabrini M, Felez M, Vazquez S, Abad J, Lee C, Garcia-Rio F, Casitas R, Mediano O, Romero Peralta S, Martinez D, Sanchez-de-la-Torre M, Barbe F, Dalmases M. Effect of CPAP treatment on BP in resistant hypertensive patients according to the BP dipping pattern and the presence of nocturnal hypertension. Hypertens Res. 2022 Mar;45(3):436-444. doi: 10.1038/s41440-021-00762-7. Epub 2021 Dec 24.
- Derived from this study: PubMed 31514508Sapina-Beltran E, Torres G, Benitez I, Fortuna-Gutierrez AM, Marquez PP, Masa JF, Corral-Penafiel J, Drager LF, Cabrini M, Felez M, Vazquez S, Abad J, Lee CH, Aung AT, Garcia-Rio F, Casitas R, Sanchez-de-la-Torre M, Gaeta AM, Barbe F, Dalmases M. Prevalence, Characteristics, and Association of Obstructive Sleep Apnea with Blood Pressure Control in Patients with Resistant Hypertension. Ann Am Thorac Soc. 2019 Nov;16(11):1414-1421. doi: 10.1513/AnnalsATS.201901-053OC.
- Individual participant dataSharing planned: Undecided
Related trials for Hypertension
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
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.
Ferran Barbé principal investigator
Spanish Respiratory Society (SEPAR)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 3 inclusion and 3 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 22 Nov 2023. 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?
Evaluation the impact of OSA and its treatment on cardiovascular outcomes (time frame: After 5 years of follow-up). 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 NCT03002558, 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 22 Nov 2023.