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Electrocardiography-based Estimation of Heart Age to Improve Blood Pressure - a Pilot Study

The Use of Electrocardiography-based Estimation of Heart Age to Improve Blood Pressure in a Primary Care Setting - a Pilot Study

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05791279
Enrollment
60
Registered
2023-03-30
Start date
2023-05-01
Completion date
2024-09-01
Last updated
2023-10-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases, Hypertension

Brief summary

Successfully communicating cardiovascular risk to patients is essential for achieving compliance to medication and lifestyle changes. An intuitive way to translate cardiovascular risk is to present a Heart Age; an ECG-based age-estimation from ECG changes which can be contrasted to a patient's chronological age. In this pilot study, the feasibility of a randomized controlled study (RCT) in which hypertensive patients in primary care will receive information about their ECG-based Heart Age in addition to standard care, or standard care alone, will be assessed, in preparation for a larger RCT.

Detailed description

Cardiovascular disease processes begin early and progress silently for many years. Fortunately, several risk-factors are modifiable, and cardiovascular risk can therefore be reduced for example by smoking cessation, dietary changes, increased physical activity in sedentary people and adherence to pharmacological risk factor reduction. To accomplish this, the patient must understand that he or she is at risk. One way to do this could be to present the risk as a Heart Age, which can be contrasted to the patient's chronological age. In a previous study, an accurate Heart Age could be obtained using conventional, 10-second ECG recordings. The ECG analysis included conventional and basic ECG measurements such as heart rate and waveform amplitudes and durations, but also combinations of advanced ECG measures from 12-lead-ECG-derived vectorcardiography and waveform complexity. However, it is not known whether the use of Heart Age can improve outcomes if applied in clinical care. To address this issue, a study in which patients, in addition to standard care, are randomized to either being presented with their Heart Age or not should be performed. In order to check the feasibility of such a randomized controlled study (RCT), a pilot study is necessary. This study will evaluate the feasibility of randomizing patients with hypertension to either being presented with their Heart Age or not, in addition to standard care, by describing the recruitment dropout rate, the quality of the recorded ECG and the tolerability of the intervention (participant experience). At the baseline visit a standardized resting blood pressure, height, weight and waist circumference will be measured. Baseline characteristics (age, sex, hypercholesterolemia, diabetes, ischemic heart disease, cerebrovascular disease, renal failure, heart failure, medications) will be recorded from the patient records. Unless a recent (\<1 month) ECG is available, a new resting ECG recording will be performed, and blood sampling will be done (total cholesterol, high-density lipoprotein \[HDL\], low-density lipoprotein \[LDL\] mmol/l, triglyceride mmol/mol, Hba1c (IFCC) mmol/mL, P-Creatinine (µmol/L). The participant will also receive a questionnaire for background information and information about tobacco and alcohol use, level of physical activity, dietary habits, medication adherence, quality of life and self-estimated health including estimating one's own risk of cardiovascular morbidity. ECG-based Heart Age will be estimated for all participants but presented only to patients in the intervention arm. A follow-up visit will be performed 6 months after the baseline visit. At follow-up, the same measurements including the same questionnaires will be obtained. Participants in the intervention arm will also receive a questionnaire on their experience of receiving information about their Heart Age (tolerability).

Interventions

information about their ECG-based Heart-Age and the Heart Age gap, i.e. the difference between chronological and ECG-based Heart Age.

Sponsors

Lund University
CollaboratorOTHER
University of Sydney
CollaboratorOTHER
Kronoberg County Council
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

Eligibility: Patients with hypertension and systolic blood pressure \>140 mm Hg (measured during the inclusion period by doctor or nurse at the primary health care center) Inclusion Criteria: * Informed consent * Diagnosed hypertension (International classification of disease (ICD-10), I10.9) * 40 - 75 years

Exclusion criteria

* ECG findings that are incompatible with or may significantly distort the Heart Age estimation (left/right bundle branch block, atrial fibrillation/flutter, tachycardia (≥100/min), abundant ventricular ectopic beats, misplaced ECG electrodes, missing leads, excessive signal noise/baseline) * Short life expectancy (\<1 year) * Pregnancy, known secondary hypertension * Predicted inability to give informed consent due to either language difficulties, cognitive impairment or other. * Systolic blood pressure \<120 mmHg at the baseline visit

Design outcomes

Primary

MeasureTime frameDescription
Recruitment rate6 monthsNumber of patients being recruited within the specified time frame
Dropout rate6 monthsNumber of patients who do not complete follow-up
Quality6 monthsNumber of Heart Age estimations with adequate ECG signal quality
Tolerability of the intervention6 monthsTolerability of the intervention assessed through questionnaires.

Secondary

MeasureTime frameDescription
Tobacco6 monthsChange in tobacco use assessed through questionnaires.
Alcohol6 monthsChange in alcohol use assessed through questionnaires.
Medication adherence6 monthsChange in medication adherence assessed through questionnaires.
Blood pressure (systolic and diastolic)6 monthsChange in blood pressure
Body-mass index (BMI)6 monthsChange in BMI
Heart Age6 monthsChange in Heart Age
Risk perception6 monthsChange in risk perception assessed through questionnaires.
HbA1c6 monthsChange in HbA1c
Physical activity6 monthsChange in physical activity assessed through questionnaires.
Dietary habits6 monthsChange in dietary habits assessed through questionnaires.

Countries

Sweden

Contacts

Primary ContactThomas Lindow, MD, PhD
thomas.akesson_lindow@med.lu.se+46470588000
Backup ContactKarin Svensson Söderberg, MD
karin.svensson-soderberg@kronoberg.se

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026