HypertensionNBP-DIPNCT07200856
Nocturnal Blood Pressure Dipping and Ventricular Repolarization in Hypertension
An observational study of Hypertension and Blood Pressure Monitoring, Ambulatory, run by Assiut University.
Trial summary
The primary aim is to determine whether non-dipping status is associated with adverse repolarization markers and impaired myocardial mechanics compared to dipper hypertensive patients. Secondary analyses will compare these findings among resistant vs. non-resistant and controlled vs. uncontrolled hypertensive groups. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Blood Pressure Monitoring, Ambulatory, Circadian Rhythm
- What is being tested?
- Nocturnal Blood Pressure Dipping
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 1 Jan 2027
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Adult patients (≥18 years) with essential hypertension attending the Cardiology Department at Assiut University Heart Hospital. All participants will undergo 24-hour ambulatory blood pressure monitoring, electrocardiography, and echocardiography to classify them into dipper and non-dipper groups
Who may be able to join
- Adults ≥18 years old
- Diagnosed with essential hypertension
- Completed 24-hour ambulatory blood pressure monitoring (ABPM)
- Availability of good-quality 12-lead ECG
- Availability of good-quality transthoracic echocardiography
Who cannot join
- Body mass index (BMI) > 34.9 kg/m²
- Atrial fibrillation or atrial flutter
- Use of QT-prolonging medications
- End-stage renal disease or liver failure
- Bundle branch block or presence of pacemaker
- Prior coronary revascularization (PCI or CABG)
- Significant electrolyte imbalance
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Impact of Nocturnal Blood Pressure Dipping on Ventricular Repolarization in Hypertensive Patients
The primary aim is to determine whether non-dipping status is associated with adverse repolarization markers and impaired myocardial mechanics compared to dipper hypertensive patients. Secondary analyses will compare these findings among resistant vs. non-resistant and controlled vs. uncontrolled hypertensive groups. This study may provide new insights into the prognostic significance of blood pressure dipping patterns in hypertensive patients.
Read the detailed description
Hypertension is a highly prevalent chronic condition and one of the leading causes of cardiovascular disease worldwide. It is associated with structural and electrical remodeling of the heart, including left ventricular hypertrophy, myocardial fibrosis, and impaired ventricular repolarization. These changes predispose patients to arrhythmias and adverse cardiovascular outcomes.
A physiological decline in blood pressure during nighttime, known as nocturnal dipping, represents a normal circadian rhythm and is considered a favorable prognostic sign. However, many hypertensive patients fail to show this nocturnal decline (non-dippers), which may indicate heightened sympathetic activity, impaired recovery during sleep, and increased cardiovascular risk. Identifying the impact of dipping status on cardiac electrical and mechanical function could therefore have important clinical value.
This study is designed as an observational prospective registry enrolling adult patients with essential hypertension. All participants will undergo 24-hour ambulatory blood pressure monitoring to determine dipping pattern, standard 12-lead electrocardiography for analysis of repolarization markers such as QTc, QT dispersion, and Tp-Te interval, and comprehensive transthoracic echocardiography including strain imaging to assess myocardial mechanics. Laboratory tests including electrolytes and renal function will also be performed to exclude confounding factors.
The primary objective is to evaluate the effect of nocturnal blood pressure dipping on ventricular repolarization parameters and echocardiographic findings in hypertensive patients. Secondary objectives include assessing differences between resistant and non-resistant hypertension as well as controlled and uncontrolled hypertension groups. The study is expected to provide novel insights into the prognostic role of dipping status and its association with electrical and functional cardiac abnormalities.
- Conditions
- Hypertension, Blood Pressure Monitoring, Ambulatory, Circadian Rhythm, Electrocardiography, Ventricular Function
- Being tested
- Nocturnal Blood Pressure Dipping
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nocturnal Blood Pressure DippingOther
Patients will be classified as dippers (≥10% nocturnal BP fall) or non-dippers (<10% nocturnal BP fall) based on 24-hour ambulatory blood pressure monitoring.
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of nocturnal BP dipping on ECG markers of ventricular repolarization
Evaluation of QTc, QT dispersion, and Tp-Te interval in dipper vs. non-dipper hypertensive patients, correlated with echocardiographic changes
Measured: At enrollment
Secondary outcomes (1)
Repolarization and echocardiographic changes in resistant vs. non-resistant hypertension
Comparison of ECG and echocardiographic markers between resistant and non-resistant hypertensive groups
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Other
- Time perspective
- Prospective
- Enrolment
- 140 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Abdelwahab Hussein Ahmed, Assiut University
- Investigators
- Mohamed Aboel-Kassem Farghal Abdelmegid, Study chair, Cardiology Department - Assiut UniversityNoha Mohamed Gamal Hashem, Study chair, Cardiology Department - Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07200856
- Sponsor's protocol ID
- AUN-CARDIO-NBP-2025
- Acronym
- NBP-DIP
- Status last verified
- Sep 2025
- First submitted
- 23 Sep 2025
- Last updated
- 1 Oct 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Demir M, Uyan U. Evaluation of Tp-e interval and Tp-e/QT ratio in patients with non-dipper hypertension. Clin Exp Hypertens. 2014;36(5):285-8. doi: 10.3109/10641963.2013.810233. Epub 2013 Jul 12.
PubMed 23848271Cuspidi C, Sala C, et al. Nocturnal blood pressure fall and left ventricular hypertrophy in untreated hypertensive patients. J Hypertens. 2013;31(6):1143-50.
Morris DA, et al. Left atrial strain predicts diastolic dysfunction severity. J Am Soc Echocardiogr. 2015;28(5):556-64.
Dudenbostel T, Calhoun DA. Resistant hypertension, left ventricular hypertrophy, and ECG changes. Curr Hypertens Rep. 2017;19(6):48.
Williams B, Mancia G, Spiering W, Agabiti Rosei E, Azizi M, Burnier M, Clement DL, Coca A, de Simone G, Dominiczak A, Kahan T, Mahfoud F, Redon J, Ruilope L, Zanchetti A, Kerins M, Kjeldsen SE, Kreutz R, Laurent S, Lip GYH, McManus R, Narkiewicz K, Ruschitzka F, Schmieder RE, Shlyakhto E, Tsioufis C, Aboyans V, Desormais I; ESC Scientific Document Group. 2018 ESC/ESH Guidelines for the management of arterial hypertension. Eur Heart J. 2018 Sep 1;39(33):3021-3104. doi: 10.1093/eurheartj/ehy339. No abstract available.
PubMed 30165516Goulart MA, Moreira DAR, Cesena FY, Souza JB, Laurinavicius AG, Consolim-Colombo FM, Sousa MG. Analysis of Ventricular Repolarization in Hypertensive Patients: Influence of Nocturnal Blood Pressure Dipping. Arq Bras Cardiol. 2025 Apr;122(4):e20240725. doi: 10.36660/abc.20240725. English, Portuguese.
PubMed 40396865
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Nocturnal Blood Pressure Dipping on Ventricular Repolarization in Hypertensive Patients
- ClinicalTrials.gov ID
- NCT07200856
- Acronym / sponsor ID
- NBP-DIP / AUN-CARDIO-NBP-2025
- Conditions
- Hypertension, Blood Pressure Monitoring, Ambulatory, Circadian Rhythm, Electrocardiography, Ventricular Function
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 1 Oct 2025 (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.
The primary aim is to determine whether non-dipping status is associated with adverse repolarization markers and impaired myocardial mechanics compared to dipper hypertensive patients. Secondary analyses will compare these findings among resistant vs. non-resistant and controlled vs. uncontrolled hypertensive groups. This study may provide new insights into the prognostic significance of blood pressure dipping patterns in hypertensive patients.
Detailed description
Hypertension is a highly prevalent chronic condition and one of the leading causes of cardiovascular disease worldwide. It is associated with structural and electrical remodeling of the heart, including left ventricular hypertrophy, myocardial fibrosis, and impaired ventricular repolarization. These changes predispose patients to arrhythmias and adverse cardiovascular outcomes.
A physiological decline in blood pressure during nighttime, known as nocturnal dipping, represents a normal circadian rhythm and is considered a favorable prognostic sign. However, many hypertensive patients fail to show this nocturnal decline (non-dippers), which may indicate heightened sympathetic activity, impaired recovery during sleep, and increased cardiovascular risk. Identifying the impact of dipping status on cardiac electrical and mechanical function could therefore have important clinical value.
This study is designed as an observational prospective registry enrolling adult patients with essential hypertension. All participants will undergo 24-hour ambulatory blood pressure monitoring to determine dipping pattern, standard 12-lead electrocardiography for analysis of repolarization markers such as QTc, QT dispersion, and Tp-Te interval, and comprehensive transthoracic echocardiography including strain imaging to assess myocardial mechanics. Laboratory tests including electrolytes and renal function will also be performed to exclude confounding factors.
The primary objective is to evaluate the effect of nocturnal blood pressure dipping on ventricular repolarization parameters and echocardiographic findings in hypertensive patients. Secondary objectives include assessing differences between resistant and non-resistant hypertension as well as controlled and uncontrolled hypertension groups. The study is expected to provide novel insights into the prognostic role of dipping status and its association with electrical and functional cardiac abnormalities.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (≥18 years) with essential hypertension attending the Cardiology Department at Assiut University Heart Hospital. All participants will undergo 24-hour ambulatory blood pressure monitoring, electrocardiography, and echocardiography to classify them into dipper and non-dipper groups
Key inclusion criteria (5 listed)
- Adults ≥18 years old
- Diagnosed with essential hypertension
- Completed 24-hour ambulatory blood pressure monitoring (ABPM)
- Availability of good-quality 12-lead ECG
- Availability of good-quality transthoracic echocardiography
Key exclusion criteria (7 listed)
- Body mass index (BMI) > 34.9 kg/m²
- Atrial fibrillation or atrial flutter
- Use of QT-prolonging medications
- End-stage renal disease or liver failure
- Bundle branch block or presence of pacemaker
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 |
|---|---|---|
| Nocturnal Blood Pressure DippingPatients will be classified as dippers (≥10% nocturnal BP fall) or non-dippers (<10% nocturnal BP fall) based on 24-hour ambulatory blood pressure monitoring. | Other | – |
Primary outcome
Effect of nocturnal BP dipping on ECG markers of ventricular repolarization
Time frame: At enrollment
Evaluation of QTc, QT dispersion, and Tp-Te interval in dipper vs. non-dipper hypertensive patients, correlated with echocardiographic changes
1 secondary outcome
Repolarization and echocardiographic changes in resistant vs. non-resistant hypertension
Time frame: At enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Background: PubMed 23848271Demir M, Uyan U. Evaluation of Tp-e interval and Tp-e/QT ratio in patients with non-dipper hypertension. Clin Exp Hypertens. 2014;36(5):285-8. doi: 10.3109/10641963.2013.810233. Epub 2013 Jul 12.
- BackgroundCuspidi C, Sala C, et al. Nocturnal blood pressure fall and left ventricular hypertrophy in untreated hypertensive patients. J Hypertens. 2013;31(6):1143-50.
- BackgroundMorris DA, et al. Left atrial strain predicts diastolic dysfunction severity. J Am Soc Echocardiogr. 2015;28(5):556-64.
- BackgroundDudenbostel T, Calhoun DA. Resistant hypertension, left ventricular hypertrophy, and ECG changes. Curr Hypertens Rep. 2017;19(6):48.
- Background: PubMed 30165516Williams B, Mancia G, Spiering W, Agabiti Rosei E, Azizi M, Burnier M, Clement DL, Coca A, de Simone G, Dominiczak A, Kahan T, Mahfoud F, Redon J, Ruilope L, Zanchetti A, Kerins M, Kjeldsen SE, Kreutz R, Laurent S, Lip GYH, McManus R, Narkiewicz K, Ruschitzka F, Schmieder RE, Shlyakhto E, Tsioufis C, Aboyans V, Desormais I; ESC Scientific Document Group. 2018 ESC/ESH Guidelines for the management of arterial hypertension. Eur Heart J. 2018 Sep 1;39(33):3021-3104. doi: 10.1093/eurheartj/ehy339. No abstract available.
- Background: PubMed 40396865Goulart MA, Moreira DAR, Cesena FY, Souza JB, Laurinavicius AG, Consolim-Colombo FM, Sousa MG. Analysis of Ventricular Repolarization in Hypertensive Patients: Influence of Nocturnal Blood Pressure Dipping. Arq Bras Cardiol. 2025 Apr;122(4):e20240725. doi: 10.36660/abc.20240725. English, Portuguese.
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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.
Mohamed Aboel-Kassem Farghal Abdelmegid study chair
Cardiology Department - Assiut University
Noha Mohamed Gamal Hashem study chair
Cardiology Department - Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension and Blood Pressure Monitoring, Ambulatory, run by Assiut University.
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 7 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: opening soon, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amr Abdelwahab Hussein Ahmed, MBBCh (01009692938, Amr.17289535@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of nocturnal BP dipping on ECG markers of ventricular repolarization (time frame: At enrollment). 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 NCT07200856, which also lists 6 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 1 Oct 2025.