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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05791279
• Other study ID #: Kronoberg_HA
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: September 1, 2024

Study information

• Verified date: October 2023
• Source: Kronoberg County Council
• Contact: Thomas Lindow, MD, PhD
• Phone: +46470588000
• Email: thomas.akesson_lindow[@]med.lu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Hypertension

Intervention

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

Locations

Country	Name	City	State
Sweden	Ryd Vardcentral	Ryd
Sweden	Tingsryd Vardcentral	Tingsryd

Sponsors (3)

Lead Sponsor	Collaborator
Kronoberg County Council	Lund University, University of Sydney

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Lindow T, Palencia-Lamela I, Schlegel TT, Ugander M. Heart age estimated using explainable advanced electrocardiography. Sci Rep. 2022 Jun 14;12(1):9840. doi: 10.1038/s41598-022-13912-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment rate	Number of patients being recruited within the specified time frame	6 months
Primary	Dropout rate	Number of patients who do not complete follow-up	6 months
Primary	Quality	Number of Heart Age estimations with adequate ECG signal quality	6 months
Primary	Tolerability of the intervention	Tolerability of the intervention assessed through questionnaires.	6 months
Secondary	Blood pressure (systolic and diastolic)	Change in blood pressure	6 months
Secondary	HbA1c	Change in HbA1c	6 months
Secondary	Physical activity	Change in physical activity assessed through questionnaires.	6 months
Secondary	Dietary habits	Change in dietary habits assessed through questionnaires.	6 months
Secondary	Tobacco	Change in tobacco use assessed through questionnaires.	6 months
Secondary	Alcohol	Change in alcohol use assessed through questionnaires.	6 months
Secondary	Medication adherence	Change in medication adherence assessed through questionnaires.	6 months
Secondary	Risk perception	Change in risk perception assessed through questionnaires.	6 months
Secondary	Body-mass index (BMI)	Change in BMI	6 months
Secondary	Heart Age	Change in Heart Age	6 months