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

NCT ID: NCT05791279

Last Updated: 2023-10-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2024-09-01

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).

Conditions

Cardiovascular Diseases; Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Heart age

Intervention Type: OTHER

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

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lund University

OTHER

Sponsor Role: collaborator

University of Sydney

OTHER

Sponsor Role: collaborator

Kronoberg County Council

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas Lindow, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Region Kronoberg, Sweden; Lund University, Lund, Sweden

Locations

Ryd Vardcentral

Ryd, , Sweden

Site Status: RECRUITING

Tingsryd Vardcentral

Tingsryd, , Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Thomas Lindow, MD, PhD

Role: CONTACT

thomas.akesson_lindow@med.lu.se

+46470588000

Karin Svensson Söderberg, MD

Role: CONTACT

karin.svensson-soderberg@kronoberg.se

Facility Contacts

Karin Svensson Soderberg, MD

Role: primary

Karin Svensson Soderberg, MD

Role: primary

References

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.

Reference Type: BACKGROUND

PMID: 35701514 (View on PubMed)

Other Identifiers

Kronoberg_HA

Identifier Type: -

Identifier Source: org_study_id