Hypertension; NephropathyNCT03651492
Effects of Nocturnal Hypertension on Sleep Quality in Renal Transplant Recipients
An observational study of Hypertension; Nephropathy and Renal Transplant, run by Federico II University at 1 site in Italy.
Trial summary
Nocturnal hypertension (i.e. blood pressure values >120/70 or 10% higher than diurnal values, as measured by ambulatory blood pressure monitoring, ABPM) is particularly frequent in renal transplant recipients (RTR), despite the use of antihypertensive drugs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension; Nephropathy, Renal Transplant, Sleep Disorder
- What is being tested?
- questionnaire administration
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2017to 31 Jan 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with functioning renal transplantation in regular follow-up at DH of renal transplantation of the University Federico II of Naples (Italy)
Who may be able to join
- Age>18 years
- Transplant vintage >1 year;
- Stable renal function in the last 6 months;
- No change in antihypertensive and immunosuppressive therapy in the last 3 months;
- No rejection episode in the last 6 months.
Who cannot join
- Intercurrent infections in the last 3 months;
- Treatment with sleeping or antidepressant pills;
- Patients with neurological problems in treatment with drugs acting on central nervous system;
- Patients unable to understand the meaning of the questions.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
University Federico II
Naples, 80131
Stefano Federico, MD, +39 081 746 2146, federico@unina.it
About this study
Nocturnal hypertension (i.e. blood pressure values >120/70 or 10% higher than diurnal values, as measured by ambulatory blood pressure monitoring, ABPM) is particularly frequent in renal transplant recipients (RTR), despite the use of antihypertensive drugs. Since RTR are also affected by several sleep disorders (like insomnia, restless legs syndrome, sleep apnoea) that frankly impair their quality of sleep (SQ), the aim of the present study is to ascertain whether a relationship exists between nocturnal hypertension and SQ. In fact, both nocturnal hypertension and sleep disorders may favour the onset or the progression of cardiovascular diseases, the first cause of death in RTR.
Read the detailed description
Hypertension affects the great majority of renal transplant recipients (RTR) and its persistence may negatively influence the outcome of the graft. Unfortunately, its diagnosis is not univocal since office measurement of blood pressure (BP) may reveal a "white coat hypertension" in normotensive subjects, or might not detect hypertension if pills are taken immediately before BP control. Therefore for a correct diagnosis the use of ambulatory BP monitoring (ABPM) is strongly advised. Recent studies employing this methodology have shown that the prevalence of nocturnal hypertension (i.e. blood pressure values >120/70 or 10% higher than diurnal values) affects a great number of renal transplant recipients (RTR), even despite the use of antihypertensive drugs ("non-dipper" patients). It is well known that nocturnal hypertension enhances the development of cardiovascular diseases, but it is not clear whether (and to what extent) it also affects the quality of sleep of these patients. Sleep disturbances like insomnia, restless legs syndrome and sleep apnoea, in fact, are particularly common in RTR, despite these patients report significantly better quality of life compared to patients with chronic renal failure under conservative or dialysis treatment. The working hypothesis of the present study is to evaluate whether any relationship exists between nocturnal hypertension and sleep quality, since also sleep disorders may favour the onet and the progression of cardiovascular diseases, the first cause of death in RTR with functioning graft.
The study will be carried out on all the available RTR in regular follow-up at the DH of Nephrology and Renal Transplantation of the University Federico II of Naples (Italy). Inclusion criteria are: age >18 years, renal transplant vintage >1 year, stable renal function in the last 6 month, no change in immunosuppressive nor antihypertensive treatment in the last 3 months, no intercurrent infection in the last 3 months. Twenty-four hour ABPM will be performed during the regular follow-up of patients in the investigator's Unit. Hypertension will be diagnosed when the patient takes antihypertensive drugs or when his . BP is >130/80 mmHg (24-hour average value), or >135/85 (average values of daily BP) or >120/70 (average values of nocturnal BP). The patient will be considered "non-dipper" when the ratio Systolic nocturnal BP/Systolic diurnal BP is >0.9.
Sleep quality will be evaluated through a validated version of the Pittsburgh Sleep Questionnaire a self-rated questionnaire, consisting of 19 questions which assess a wide variety of factors relating to sleep quality, including estimates of sleep duration and latency and of frequency and severity of specific sleep-related problems. These 19 items are grouped into seven-component scores, each weighted equally on a 0-3 scale. The seven components are then summed to yield a global index (PSQI) ranging between 0 and 21; higher scores indicate a worse sleep quality (>5, poor sleepers; <5, good sleepers). The seven components of the PSQI are subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction. The relationship between nocturnal hypertension and sleep quality will be evaluated either by bivariate analysis and by multiple linear regression analyses. In the multivariate model, all the variables associated to an elevated night/day systolic pressure ratio will be considered if the P value is 0.10 or less at bivariate analysis. The relationship between increased night/day SBP ratio and increased PSQI will be also investigated by multivariate logistic regression model.
- Conditions
- Hypertension; Nephropathy, Renal Transplant, Sleep Disorder
- Being tested
- questionnaire administration
- Keywords
- nocturnal hypertension, renal transplantation, sleep quality
- Medical subject headings
- Hypertensive Nephropathy, Sleep Wake Disorders, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaire administrationBehavioural
All the patients will be administered the Pittsburgh Questionnaire after completion of ABPM.
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of "poor sleepers", as assessed by Pittsburgh Questionnaire, among renal transplant recipients with elevated blood pressure, measured by ambulatory continuous monitoring.
Sleep quality will be evaluated by the Pittsburgh Questionnaire, which allows to investigate on 7 different components of sleep, determining a score ranging between 0 and 19: a score>5 defines a "poor sleeper". Through bivariate and multivariate analysis, the study will evaluate which relationship exists between nocturnal hypertension ands sleep quality.
Measured: Given the cross-sectional nature of the study, there is a single determination of sleep quality in each patient, carried out after completion of 24-hour ABPM, during a scheduled follow-up visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2018
- Study start1 Jun 2017
- Primary completion1 Jun 2019 (estimated)
- Study completion31 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension; NephropathyStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Massimo Sabbatini, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03651492
- Sponsor's protocol ID
- FedericoIIUniversity
- Status last verified
- Aug 2018
- First submitted
- 17 Aug 2018
- Last updated
- 29 Aug 2018
- 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 29 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Nocturnal Hypertension on Sleep Quality in Renal Transplant Recipients
- ClinicalTrials.gov ID
- NCT03651492
- Acronym / sponsor ID
- FedericoIIUniversity
- Conditions
- Hypertension; Nephropathy, Renal Transplant, Sleep Disorder
- Keywords
- nocturnal hypertension, renal transplantation, sleep quality
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 1 Jun 2019 (estimated)
- Study completion
- 31 Jan 2020 (estimated)
- First posted
- 29 Aug 2018 (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.
Nocturnal hypertension (i.e. blood pressure values >120/70 or 10% higher than diurnal values, as measured by ambulatory blood pressure monitoring, ABPM) is particularly frequent in renal transplant recipients (RTR), despite the use of antihypertensive drugs. Since RTR are also affected by several sleep disorders (like insomnia, restless legs syndrome, sleep apnoea) that frankly impair their quality of sleep (SQ), the aim of the present study is to ascertain whether a relationship exists between nocturnal hypertension and SQ. In fact, both nocturnal hypertension and sleep disorders may favour the onset or the progression of cardiovascular diseases, the first cause of death in RTR.
Detailed description
Hypertension affects the great majority of renal transplant recipients (RTR) and its persistence may negatively influence the outcome of the graft. Unfortunately, its diagnosis is not univocal since office measurement of blood pressure (BP) may reveal a "white coat hypertension" in normotensive subjects, or might not detect hypertension if pills are taken immediately before BP control. Therefore for a correct diagnosis the use of ambulatory BP monitoring (ABPM) is strongly advised. Recent studies employing this methodology have shown that the prevalence of nocturnal hypertension (i.e. blood pressure values >120/70 or 10% higher than diurnal values) affects a great number of renal transplant recipients (RTR), even despite the use of antihypertensive drugs ("non-dipper" patients). It is well known that nocturnal hypertension enhances the development of cardiovascular diseases, but it is not clear whether (and to what extent) it also affects the quality of sleep of these patients. Sleep disturbances like insomnia, restless legs syndrome and sleep apnoea, in fact, are particularly common in RTR, despite these patients report significantly better quality of life compared to patients with chronic renal failure under conservative or dialysis treatment. The working hypothesis of the present study is to evaluate whether any relationship exists between nocturnal hypertension and sleep quality, since also sleep disorders may favour the onet and the progression of cardiovascular diseases, the first cause of death in RTR with functioning graft.
The study will be carried out on all the available RTR in regular follow-up at the DH of Nephrology and Renal Transplantation of the University Federico II of Naples (Italy). Inclusion criteria are: age >18 years, renal transplant vintage >1 year, stable renal function in the last 6 month, no change in immunosuppressive nor antihypertensive treatment in the last 3 months, no intercurrent infection in the last 3 months. Twenty-four hour ABPM will be performed during the regular follow-up of patients in the investigator's Unit. Hypertension will be diagnosed when the patient takes antihypertensive drugs or when his . BP is >130/80 mmHg (24-hour average value), or >135/85 (average values of daily BP) or >120/70 (average values of nocturnal BP). The patient will be considered "non-dipper" when the ratio Systolic nocturnal BP/Systolic diurnal BP is >0.9.
Sleep quality will be evaluated through a validated version of the Pittsburgh Sleep Questionnaire a self-rated questionnaire, consisting of 19 questions which assess a wide variety of factors relating to sleep quality, including estimates of sleep duration and latency and of frequency and severity of specific sleep-related problems. These 19 items are grouped into seven-component scores, each weighted equally on a 0-3 scale. The seven components are then summed to yield a global index (PSQI) ranging between 0 and 21; higher scores indicate a worse sleep quality (>5, poor sleepers; <5, good sleepers). The seven components of the PSQI are subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction. The relationship between nocturnal hypertension and sleep quality will be evaluated either by bivariate analysis and by multiple linear regression analyses. In the multivariate model, all the variables associated to an elevated night/day systolic pressure ratio will be considered if the P value is 0.10 or less at bivariate analysis. The relationship between increased night/day SBP ratio and increased PSQI will be also investigated by multivariate logistic regression model.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with functioning renal transplantation in regular follow-up at DH of renal transplantation of the University Federico II of Naples (Italy)
Key inclusion criteria (5 listed)
- Age>18 years
- Transplant vintage >1 year;
- Stable renal function in the last 6 months;
- No change in antihypertensive and immunosuppressive therapy in the last 3 months;
- No rejection episode in the last 6 months.
Key exclusion criteria (4 listed)
- Intercurrent infections in the last 3 months;
- Treatment with sleeping or antidepressant pills;
- Patients with neurological problems in treatment with drugs acting on central nervous system;
- Patients unable to understand the meaning of the questions.
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 |
|---|---|---|
| questionnaire administrationAll the patients will be administered the Pittsburgh Questionnaire after completion of ABPM. | Behavioural | – |
Primary outcome
Prevalence of "poor sleepers", as assessed by Pittsburgh Questionnaire, among renal transplant recipients with elevated blood pressure, measured by ambulatory continuous monitoring.
Time frame: Given the cross-sectional nature of the study, there is a single determination of sleep quality in each patient, carried out after completion of 24-hour ABPM, during a scheduled follow-up visit.
Sleep quality will be evaluated by the Pittsburgh Questionnaire, which allows to investigate on 7 different components of sleep, determining a score ranging between 0 and 19: a score>5 defines a "poor sleeper". Through bivariate and multivariate analysis, the study will evaluate which relationship exists between nocturnal hypertension ands sleep quality.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2018.
- Individual participant dataSharing planned: No
Related trials for Hypertension; Nephropathy
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
RecruitingPhase 3
A Phase III Renal Outcomes and Cardiovascular Mortality Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin in Participants With Chronic Kidney Disease and High Blood Pressure
Chronic Kidney Disease and Hypertension
Recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
Not yet recruiting
Community Health Worker Nutrition Self-Management Support for Cardio-Kidney-Metabolic Health
Hypertension (HTN), CKD - Chronic Kidney Disease
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.
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; Nephropathy and Renal Transplant, run by Federico II University at 1 site in Italy.
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 5 inclusion and 4 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 29 Aug 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 Italy. 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?
Contact Massimo Sabbatini, PhD (+39081 746 2614, sabbatin@unina.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of "poor sleepers", as assessed by Pittsburgh Questionnaire, among renal transplant recipients with elevated blood pressure, measured by ambulatory continuous monitoring. (time frame: Given the cross-sectional nature of the study, there is a single determination of sleep quality in each patient, carried out after completion of 24-hour ABPM, during a scheduled follow-up visit.). 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 Aug 2018.