NCT07847463

Brief Summary

To evaluate the ability of exercise ECG to discriminate between hypertensive heart disease-related and CAD-related abnormalities

Trial Health

77
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
36mo left

Started Sep 2026

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress3%
Sep 2026Sep 2029

Study Start

First participant enrolled

September 1, 2026

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

September 18, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 29, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2029

Last Updated

September 29, 2026

Status Verified

September 1, 2026

Enrollment Period

2 years

First QC Date

September 18, 2026

Last Update Submit

September 25, 2026

Conditions

Keywords

exercise ECGLVHCCTAStress CMRCADtransthoracic echocardiographyTTE

Outcome Measures

Primary Outcomes (1)

  • diagnostic performance of exercise ECG across the four predefined groups.

    Differences in ECG response patterns will be compared according to the presence of LVH and obstructive CAD. Multivariable analysis will be performed to identify independent ECG predictors associated with obstructive CAD and inducible ischemia.

    From enrollment through completion of all diagnostic evaluations, assessed up to 3 months after enrollment.

Study Arms (4)

LVH with obstructive CAD

LVH with obstructive CAD

LVH without obstructive CAD

LVH without obstructive CAD

No LVH with obstructive CAD

No LVH with obstructive CAD

No LVH without obstructive CAD

No LVH without obstructive CAD

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

consecutive patients undergoing evaluation for suspected coronary artery disease will undergo exercise ECG testing (ExECG), transthoracic echocardiography (TTE), stress cardiac magnetic resonance (CMR), and coronary computed tomography angiography (CCTA). Patients will be stratified into four groups according to the presence or absence of LVH and obstructive CAD: LVH with obstructive CAD LVH without obstructive CAD No LVH with obstructive CAD No LVH without obstructive CAD

You may qualify if:

  • Patients with CAD and LVH

You may not qualify if:

  • Patients with RBBB

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda Ospedaliero-Universitaria Pisana

Pisa, PI, 56124, Italy

RECRUITING

MeSH Terms

Conditions

Hypertrophy, Left Ventricular

Condition Hierarchy (Ancestors)

CardiomegalyHeart DiseasesCardiovascular DiseasesHypertrophyPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhDs

Study Record Dates

First Submitted

September 18, 2026

First Posted

September 29, 2026

Study Start

September 1, 2026

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

September 1, 2029

Last Updated

September 29, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will be made available upon reasonable request following the completion of all planned analyses and subsequent publication of the resulting manuscripts

Locations