NCT07200856

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.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
8mo left

Started Oct 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress48%
Oct 2025Jan 2027

First Submitted

Initial submission to the registry

September 23, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 1, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

October 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

October 1, 2025

Status Verified

September 1, 2025

Enrollment Period

1 year

First QC Date

September 23, 2025

Last Update Submit

September 23, 2025

Conditions

HypertensionBlood Pressure Monitoring, AmbulatoryCircadian RhythmElectrocardiographyVentricular Function

Outcome Measures

Primary Outcomes (1)

  • 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

    At enrollment

Secondary Outcomes (1)

  • Repolarization and echocardiographic changes in resistant vs. non-resistant hypertension

    At enrollment

Interventions

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • 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.

    PMID: 23848271BACKGROUND

  • 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.

    BACKGROUND

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

    BACKGROUND

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

    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.

    PMID: 30165516BACKGROUND

  • 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.

    PMID: 40396865BACKGROUND

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Mohamed Aboel-Kassem Farghal Abdelmegid

    Cardiology Department - Assiut University

    STUDY CHAIR

  • Noha Mohamed Gamal Hashem

    Cardiology Department - Assiut University

    STUDY CHAIR

Central Study Contacts

Amr Abdelwahab Hussein Ahmed, MBBCh

CONTACT

01009692938Amr.17289535@med.aun.edu.eg

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

September 23, 2025

First Posted

October 1, 2025

Study Start

October 1, 2025

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

January 1, 2027

Last Updated

October 1, 2025

Record last verified: 2025-09