Hypertension SecondaryKYNTOSANCT04646902
Kynurenine/Tryptophan Ratio in Hypertension Associated to Obstructive Sleep Apnea
An observational study of Hypertension Secondary, run by Universidade Nova de Lisboa at 5 sites in Portugal.
Trial summary
Obstructive Sleep Apnea (OSA) is an independent risk factor for hypertension (HTN) and the most common cause of resistant HTN. The mechanisms underlying OSA-associated HTN are not completely understood. This is crucial to find novel therapeutic targets of OSA-associated HTN. Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension Secondary
- How many people
- 203 participants
- Where
- 5 sitesPortugal
- Study dates
- 25 Mar 2021to 1 Mar 2024
- 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 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will include 4 groups of adults: healthy volunteers; normotensive OSA patients; hypertensive OSA patients; hypertensive non OSA patients.
Who may be able to join
- Adults ≥ 30 years old attending the outpatient clinics of the clinical sites.
- Diagnosis of hypertension defined either as: a) use of antihypertensive drug(s) and stable dose for at least 2 weeks prior to inclusion; or b) in untreated patients: office systolic blood pressure values >= 140 mmHg and/ or diastolic blood pressure values >= 90 mmHg.
- Able to understand and communicate effectively with study personnel.
- Giving written informed consent to participate.
Who cannot join
- Self-reported pregnancy or breastfeeding.
- Patients on haemodialysis or peritoneal dialysis.
- Chronic liver disease with Child-Pugh score B or higher.
- Hypertension attributed to renal artery stenosis, primary hyperaldosteronism, pheochromocytoma, Cushing's syndrome, coarctation of aorta.
- History of any OSA surgical treatment to the palatal and hypopharyngeal regions, notably uvulopalatopharyngoplasty surgery (UPPP), palatal radio frequency ablation, tonsillectomy, lingual tonsillectomy, partial glossectomy, tongue base radio frequency ablation, genioglossal advancement, hyoid suspension, maxillomandibular advancement surgery (MMA) and active use of hypoglossal nerve stimulator.
- Patients with a good adherence to CPAP, defined as the use of CPAP for at least 4 hours/night on 70% of nights during the last 3 months.
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- Pulmonary hypertension.
- Current diagnosed oncological disease.
- Patients with known chronic or acute infectious diseases.
- Other current severe progressive or uncontrolled disease which in the judgement of the investigator renders the patient unsuitable for the study
- CONTROLS (individuals without hypertension with and without OSA) For each case, an age and gender-matched control will be selected.
- Pregnancy or breastfeeding.
- Patients on haemodialysis or peritoneal dialysis.
- Chronic liver disease with Child-Pugh score b or higher.
- History of any OSA surgical treatment to the palatal and hypopharyngeal regions, notably uvulopalatopharyngoplasty surgery (UPPP), palatal radio frequency ablation, tonsillectomy, lingual tonsillectomy, partial glossectomy, tongue base radio frequency ablation, genioglossal advancement, hyoid suspension, maxillomandibular advancement surgery (MMA) and active use of hypoglossal nerve stimulator.
- Patients with a good adherence to CPAP, defined as the use of CPAP for at least 4 hours/night on 70% of nights during the last 3 months.
- Pulmonary hypertension.
- Current diagnosed oncological disease.
- Patients with known chronic or acute infectious diseases.
- Patients with known chronic or acute infectious diseases.
- Other current severe progressive or uncontrolled disease which in the judgement of the investigator renders the patient unsuitable for the study.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Portugal5 sites
Centro Hospitalar de Lisboa Central
Lisbon
Centro Hospitalar Lisboa Ocidental
Lisbon
Hospital Beatriz Ângelo
Lisbon
Hospital da Luz
Lisbon
Hospital Fernando Fonseca
Lisbon
About this study
Official title: Relevance of the Ratio Kynurenine/Tryptophan to Characterize Hypertension Associated to Obstructive Sleep Apnea (KYNTOSA)
Obstructive Sleep Apnea (OSA) is an independent risk factor for hypertension (HTN) and the most common cause of resistant HTN. The mechanisms underlying OSA-associated HTN are not completely understood. This is crucial to find novel therapeutic targets of OSA-associated HTN. The Aryl Hydrocarbon Receptor (AHR) is a cytosolic transcription factor that has been linked with the pathogenesis of HTN.
This study aims to evaluate the role of endogenous ligands of AHR such as kynurenine in discriminating patients with OSA-associated HTN. For that aim, a case-control study will be performed in patients with and without hypertension exposed and not exposed to OSA. Kynurenine and other metabolites will be quantified in urine and serum samples.
- Conditions
- Hypertension Secondary
- Keywords
- hypertension, obstructive sleep apnea, tryptophan, aryl hydrocarbon receptor
- Medical subject headings
- Hypertension, Sleep Apnea, Obstructive
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 |
|---|---|---|
| HTN_OSA | Patients with hypertension* with obstructive sleep apnea** * Hypertension will be defined as: i) use of antihypertensive drug(s) and stable dose for at least 2 weeks prior to inclusion; or ii) in untreated patients: office systolic blood pressure values >= 140 mmHg and/ or diastolic blood pressure values >= 90 mmHg. ** OSA will be defined with a polysomnography level 1, 2 or 3 performed within the previous twelve months with: * an apnea-hypopnea index > 5 events per hour (with more than 50% of obstructive events) associated with symptoms (associated sleepiness, fatigue, insomnia, snoring, subjective nocturnal respiratory disturbance or observed apnea) or medical/psychiatric disorder (hypertension, coronary artery disease, atrial fibrillation, congestive heart failure, stroke, diabetes, cognitive dysfunction, or mood disorder), OR * an apnea-hypopnea index > 15 events per hour, AND * no significant changes in health, medications, or lifestyle since the polysomnography. | |
| HTN_NoOSA | Patients with hypertension without obstructive sleep apnea | |
| NoHTN_OSA | Patients without hypertension with obstructive sleep apnea | |
| NoHTN_NoOSA | Patients without hypertension without obstructive sleep apnea (healthy controls) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kynurenine / Tryptophan ratio
Ratio between kynurenine and tryptophan concentrations
Measured: Day 1 (visit 1)
Secondary outcomes (1)
Concentrations of metabolites
The relevant metabolites and their concentration will be identified by Partial Least Square Discriminant Analysis (PLS-DA) applied to non-targeted metabolomics.
Measured: Day 1 (visit 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2020
- Study start25 Mar 2021
- Primary completion1 Sep 2023
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension SecondaryStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Nova de Lisboa
- Sponsor type
- University, hospital or other
- Collaborators
- Centro Hospitalar Lisboa Ocidental, Centro Hospitalar de Lisboa Central, Hospital Beatriz Ângelo, Hospital Fernando Fonseca, Hospital da Luz, Portugal
- Responsible party
- Sponsor
- Investigators
- Maria E Monteiro, PhD, Principal investigator, Universidade NOVA Lisboa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04646902
- Sponsor's protocol ID
- Kyntosa_02_20200428
- Other IDs
- PTDC/MED-TOX30418/2017
- Acronym
- KYNTOSA
- Status last verified
- Dec 2023
- First submitted
- 12 Oct 2020
- Last updated
- 7 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relevance of the Ratio Kynurenine/Tryptophan to Characterize Hypertension Associated to Obstructive Sleep Apnea (KYNTOSA)
- ClinicalTrials.gov ID
- NCT04646902
- Acronym / sponsor ID
- KYNTOSA / Kyntosa_02_20200428
- Conditions
- Hypertension Secondary
- Keywords
- hypertension, obstructive sleep apnea, tryptophan, aryl hydrocarbon receptor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 203 participants (actual)
- Lead sponsor
- Universidade Nova de LisboaUniversity, hospital or other
- Collaborators
- Centro Hospitalar Lisboa Ocidental, Centro Hospitalar de Lisboa Central, Hospital Beatriz Ângelo, Hospital Fernando Fonseca, Hospital da Luz, Portugal
- Study start
- 25 Mar 2021 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 30 Nov 2020 (actual)
- 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 (OSA) is an independent risk factor for hypertension (HTN) and the most common cause of resistant HTN. The mechanisms underlying OSA-associated HTN are not completely understood. This is crucial to find novel therapeutic targets of OSA-associated HTN. The Aryl Hydrocarbon Receptor (AHR) is a cytosolic transcription factor that has been linked with the pathogenesis of HTN.
This study aims to evaluate the role of endogenous ligands of AHR such as kynurenine in discriminating patients with OSA-associated HTN. For that aim, a case-control study will be performed in patients with and without hypertension exposed and not exposed to OSA. Kynurenine and other metabolites will be quantified in urine and serum samples.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HTN_OSA | – | –Patients with hypertension* with obstructive sleep apnea** * Hypertension will be defined as: i) use of antihypertensive drug(s) and stable dose for at least 2 weeks prior to inclusion; or ii) in untreated patients: office systolic blood pressure values >= 140 mmHg and/ or diastolic blood pressure values >= 90 mmHg. ** OSA will be defined with a polysomnography level 1, 2 or 3 performed within the previous twelve months with: * an apnea-hypopnea index > 5 events per hour (with more than 50% of obstructive events) associated with symptoms (associated sleepiness, fatigue, insomnia, snoring, subjective nocturnal respiratory disturbance or observed apnea) or medical/psychiatric disorder (hypertension, coronary artery disease, atrial fibrillation, congestive heart failure, stroke, diabetes, cognitive dysfunction, or mood disorder), OR * an apnea-hypopnea index > 15 events per hour, AND * no significant changes in health, medications, or lifestyle since the polysomnography. |
| HTN_NoOSA | – | –Patients with hypertension without obstructive sleep apnea |
| NoHTN_OSA | – | –Patients without hypertension with obstructive sleep apnea |
| NoHTN_NoOSA | – | –Patients without hypertension without obstructive sleep apnea (healthy controls) |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include 4 groups of adults: healthy volunteers; normotensive OSA patients; hypertensive OSA patients; hypertensive non OSA patients.
Key inclusion criteria (4 listed)
- Adults ≥ 30 years old attending the outpatient clinics of the clinical sites.
- Diagnosis of hypertension defined either as: a) use of antihypertensive drug(s) and stable dose for at least 2 weeks prior to inclusion; or b) in untreated patients: office systolic blood pressure values >= 140 mmHg and/ or diastolic blood pressure values >= 90 mmHg.
- Able to understand and communicate effectively with study personnel.
- Giving written informed consent to participate.
Key exclusion criteria (21 listed)
- Self-reported pregnancy or breastfeeding.
- Patients on haemodialysis or peritoneal dialysis.
- Chronic liver disease with Child-Pugh score B or higher.
- Hypertension attributed to renal artery stenosis, primary hyperaldosteronism, pheochromocytoma, Cushing's syndrome, coarctation of aorta.
- History of any OSA surgical treatment to the palatal and hypopharyngeal regions, notably uvulopalatopharyngoplasty surgery (UPPP), palatal radio frequency ablation, tonsillectomy, lingual tonsillectomy, partial glossectomy, tongue base radio frequency ablation, genioglossal advancement, hyoid suspension, maxillomandibular advancement surgery (MMA) and active use of hypoglossal nerve stimulator.
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
Kynurenine / Tryptophan ratio
Time frame: Day 1 (visit 1)
Ratio between kynurenine and tryptophan concentrations
1 secondary outcome
Concentrations of metabolites
Time frame: Day 1 (visit 1)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2023.
- Individual participant dataSharing planned: No
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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.
Maria E Monteiro, PhD principal investigator
Universidade NOVA Lisboa
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension Secondary, run by Universidade Nova de Lisboa at 5 sites in Portugal.
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 21 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: status not confirmed, as of the sponsor's last update on 7 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Portugal. 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?
Results are not available in the source record.
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?
Kynurenine / Tryptophan ratio (time frame: Day 1 (visit 1)). 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 7 Dec 2023.