Clinical trial NCT05791279: Electrocardiography-based Estimation of Heart Age to Improve Blood Pressure - a Pilot Study
Official title: The Use of Electrocardiography-based Estimation of Heart Age to Improve Blood Pressure in a Primary Care Setting - a Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiovascular Diseases
Hypertension
Lead sponsor: Kronoberg County Council
Sponsor class: OTHER_GOV
Collaborators: name: Lund University
name: University of Sydney
First posted: 2023-03-30
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

Eligibility 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

Primary outcomes:
measure: Recruitment rate
timeFrame: 6 months
measure: Dropout rate
timeFrame: 6 months
measure: Quality
timeFrame: 6 months
measure: Tolerability of the intervention
timeFrame: 6 months
Secondary outcomes:
measure: Blood pressure (systolic and diastolic)
timeFrame: 6 months
measure: HbA1c
timeFrame: 6 months
measure: Physical activity
timeFrame: 6 months
measure: Dietary habits
timeFrame: 6 months
measure: Tobacco
timeFrame: 6 months
measure: Alcohol
timeFrame: 6 months
measure: Medication adherence
timeFrame: 6 months
measure: Risk perception
timeFrame: 6 months
measure: Body-mass index (BMI)
timeFrame: 6 months
measure: Heart Age
timeFrame: 6 months
Other outcomes:
Locations:
city: Ryd
country: Sweden
facility: Ryd Vardcentral
city: Tingsryd
country: Sweden
facility: Tingsryd Vardcentral
Study officials:
affiliation: Region Kronoberg, Sweden; Lund University, Lund, Sweden
name: Thomas Lindow, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.