Nocturnal Blood Pressure Dipping and Ventricular Repolarization in Hypertension (NBP-DIP)

September 23, 2025 updated by: Amr Abdelwahab Hussein Ahmed, Assiut University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

140

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Repolarization and echocardiographic changes in resistant vs. non-resistant hypertension
Time Frame: At enrollment
Comparison of ECG and echocardiographic markers between resistant and non-resistant hypertensive groups
At enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Chair: Mohamed Aboel-Kassem Farghal Abdelmegid, Cardiology Department - Assiut University
  • Study Chair: Noha Mohamed Gamal Hashem, Cardiology Department - Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2025

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

September 23, 2025

First Submitted That Met QC Criteria

September 23, 2025

First Posted (Estimated)

October 1, 2025

Study Record Updates

Last Update Posted (Estimated)

October 1, 2025

Last Update Submitted That Met QC Criteria

September 23, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AUN-CARDIO-NBP-2025

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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