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

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases; Hypertension
• Intervention / Treatment: Other: Heart age

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).

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Thomas Lindow, MD, PhD; Phone Number: +46470588000; Email: thomas.akesson_lindow@med.lu.se
• Study Contact Backup: Name: Karin Svensson Söderberg, MD; Email: karin.svensson-soderberg@kronoberg.se

Study Locations

• Sweden
  • Ryd, Sweden
    • Recruiting
    • Ryd Vardcentral
    • Contact: Karin Svensson Soderberg, MD
  • Tingsryd, Sweden
    • Recruiting
    • Tingsryd Vardcentral
    • Contact: Karin Svensson Soderberg, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interventional arm; The participants in the intervention group will receive information about their ECG-based Heart-Age and the Heart Age. The estimated Heart Age and Heart Age Gap will be presented in writing to the participants in the experimental arm within 2 weeks after the baseline visit. The presentation will include a brief and easy-to-understand description on how the Heart Age has been estimated. In addition, patients will receive information about general advice on how to improve blood pressure levels and reduce the risk of future cardiovascular disease by adopting a healthy lifestyle and adhering to the prescribed medication. This information will be the same for participants in the two study arms, and is based on recommendations from the European Society of Cardiology. For patients in the intervention group the ordinary primary care physicians will also be informed about the ECG-based Heart-Age.	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.
No Intervention: Control arm; The control group will receive standard care according to routine care at the individual primary health care center, and receive the same general advice, on how to improve blood pressure levels and/or to reduce risks of future cardiovascular disease, as the participants in the intervention group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment rate	Number of patients being recruited within the specified time frame	6 months
Dropout rate	Number of patients who do not complete follow-up	6 months
Quality	Number of Heart Age estimations with adequate ECG signal quality	6 months
Tolerability of the intervention	Tolerability of the intervention assessed through questionnaires.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c	Change in HbA1c	6 months
Physical activity	Change in physical activity assessed through questionnaires.	6 months
Dietary habits	Change in dietary habits assessed through questionnaires.	6 months
Tobacco	Change in tobacco use assessed through questionnaires.	6 months
Alcohol	Change in alcohol use assessed through questionnaires.	6 months
Medication adherence	Change in medication adherence assessed through questionnaires.	6 months
Risk perception	Change in risk perception assessed through questionnaires.	6 months
Body-mass index (BMI)	Change in BMI	6 months
Heart Age	Change in Heart Age	6 months
Blood pressure (systolic and diastolic)	Change in blood pressure	6 months

Collaborators and Investigators

• Sponsor: Kronoberg County Council
• Collaborators: Lund University; University of Sydney
• Investigators: Principal Investigator: Thomas Lindow, MD, PhD, Region Kronoberg, Sweden; Lund University, Lund, Sweden

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: February 20, 2023
• First Submitted That Met QC Criteria: March 17, 2023
• First Posted (Actual): March 30, 2023

Study Record Updates

• Last Update Posted (Actual): October 11, 2023
• Last Update Submitted That Met QC Criteria: October 9, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: Kronoberg_HA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No