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RecruitingNCT05791279Updated Oct 11, 2023

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

An interventional study of Heart age in Cardiovascular Diseases and Hypertension, sponsored by Kronoberg County Council. Recruiting at 2 sites in Sweden. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-10-11.

Sponsored by Kronoberg County Council · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
40 Years to 75 Years
Sex
All
01

Study 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.

Read the 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).

02

Conditions studied

  • Cardiovascular Diseases
  • Hypertension
03

Who can participate

Ages eligible
40 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Inclusion Criteria:

  • Informed consent
  • Diagnosed hypertension (International classification of disease (ICD-10), I10.9)
  • 40 - 75 years

Exclusion criteria

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
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • 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

  • 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.

Interventions

  • OtherHeart age

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

05

What researchers measure

Primary outcomes

  1. Recruitment rate

    Number of patients being recruited within the specified time frame

    Time frame: 6 months

  2. Dropout rate

    Number of patients who do not complete follow-up

    Time frame: 6 months

  3. Quality

    Number of Heart Age estimations with adequate ECG signal quality

    Time frame: 6 months

  4. Tolerability of the intervention

    Tolerability of the intervention assessed through questionnaires.

    Time frame: 6 months

Secondary outcomes

  1. Blood pressure (systolic and diastolic)

    Change in blood pressure

    Time frame: 6 months

  2. HbA1c

    Change in HbA1c

    Time frame: 6 months

  3. Physical activity

    Change in physical activity assessed through questionnaires.

    Time frame: 6 months

  4. Dietary habits

    Change in dietary habits assessed through questionnaires.

    Time frame: 6 months

  5. Tobacco

    Change in tobacco use assessed through questionnaires.

    Time frame: 6 months

  6. Alcohol

    Change in alcohol use assessed through questionnaires.

    Time frame: 6 months

  7. Medication adherence

    Change in medication adherence assessed through questionnaires.

    Time frame: 6 months

  8. Risk perception

    Change in risk perception assessed through questionnaires.

    Time frame: 6 months

  9. Body-mass index (BMI)

    Change in BMI

    Time frame: 6 months

  10. Heart Age

    Change in Heart Age

    Time frame: 6 months

06

Study locations

2 of 2 sites recruiting
  • Ryd Vardcentral
    Ryd, Sweden
    • Karin Svensson Soderberg, MD · Contact
    Recruiting
  • Tingsryd Vardcentral
    Tingsryd, Sweden
    • Karin Svensson Soderberg, MD · Contact
    Recruiting
07

References and documents

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. PubMed 35701514 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT05791279
Lead sponsor
Kronoberg County Council
Collaborators
Lund University, University of Sydney
Responsible party
Sponsor
First posted
Mar 30, 2023
Start date
May 1, 2023
Primary completion
Sep 1, 2024 (estimated)
Completion
Sep 1, 2024 (estimated)
Last update
Oct 11, 2023

Study contacts

Thomas Lindow, MD, PhD
Contact
thomas.akesson_lindow@med.lu.se
+46470588000
Karin Svensson Söderberg, MD
Contact
karin.svensson-soderberg@kronoberg.se
Thomas Lindow, MD, PhD
principal investigator · Region Kronoberg, Sweden; Lund University, Lund, Sweden

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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