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Not yet recruiting NCT07200856

Nocturnal Blood Pressure Dipping and Ventricular Repolarization in Hypertension

Observational Hypertension Blood Pressure Monitoring, Ambulatory Circadian Rhythm Electrocardiography

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Nocturnal Blood Pressure Dipping.
Who it may be relevant to
Registry conditions: Hypertension, Blood Pressure Monitoring, Ambulatory, Circadian Rhythm, Electrocardiography. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Impact of Nocturnal Blood Pressure Dipping on Ventricular Repolarization in Hypertensive Patients

Overview

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.

Interventions

  • Other 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.

Primary outcome measures

  • Effect of nocturnal BP dipping on ECG markers of ventricular repolarization [Time frame: At enrollment]
Secondary outcome measures (1)
  • Repolarization and echocardiographic changes in resistant vs. non-resistant hypertension [Time frame: At enrollment]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Center list to be confirmed — check the primary protocol.

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. PMID 23848271
  • 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.
  • 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 PMID 30165516
  • 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 40396865

Identifiers

NCT: NCT07200856 · AUN-CARDIO-NBP-2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗