Ignite Creation Date:
2025-12-24 @ 11:31 PM
Ignite Modification Date:
2025-12-25 @ 9:19 PM
Study NCT ID:
NCT07200856
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-01
First Post:
2025-09-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Nocturnal Blood Pressure Dipping and Ventricular Repolarization in Hypertension
Sponsor:
Assiut University
Organization:
Study Overview
Official Title:
Impact of Nocturnal Blood Pressure Dipping on Ventricular Repolarization in Hypertensive Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NBP-DIP
Brief 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. 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.
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: