Nocturnal Blood Pressure Dipping and Ventricular Repolarization in Hypertension

NCT ID: NCT07200856

Last Updated: 2025-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

140 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-10-01

Study Completion Date

2027-01-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Hypertension Blood Pressure Monitoring, Ambulatory Circadian Rhythm Electrocardiography Ventricular Function

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Nocturnal Blood Pressure Dipping

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assiut University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Amr Abdelwahab Hussein Ahmed

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mohamed Aboel-Kassem Farghal Abdelmegid

Role: STUDY_CHAIR

Cardiology Department - Assiut University

Noha Mohamed Gamal Hashem

Role: STUDY_CHAIR

Cardiology Department - Assiut University

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Amr Abdelwahab Hussein Ahmed, MBBCh

Role: CONTACT

01009692938

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 23848271 (View on PubMed)

Cuspidi C, Sala C, et al. Nocturnal blood pressure fall and left ventricular hypertrophy in untreated hypertensive patients. J Hypertens. 2013;31(6):1143-50.

Reference Type BACKGROUND

Morris DA, et al. Left atrial strain predicts diastolic dysfunction severity. J Am Soc Echocardiogr. 2015;28(5):556-64.

Reference Type BACKGROUND

Dudenbostel T, Calhoun DA. Resistant hypertension, left ventricular hypertrophy, and ECG changes. Curr Hypertens Rep. 2017;19(6):48.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 30165516 (View on PubMed)

Goulart 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.

Reference Type BACKGROUND
PMID: 40396865 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AUN-CARDIO-NBP-2025

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Angiotensin-(1-7) Cardiovascular Effects in Aging
NCT05301192 RECRUITING EARLY_PHASE1