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Cardiovascular DiseasesNCT05791279

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

A study testing Heart age in people with Cardiovascular Diseases and Hypertension, run by Kronoberg County Council at 2 sites in Sweden.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 40 to 75 years
Conditions the study is for
Cardiovascular Diseases, Hypertension
What is being tested?
Heart age
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
2 sitesSweden
Study dates
1 May 2023to 1 Sep 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

Thomas Lindow, MD, PhD contact

+46470588000

thomas.akesson_lindow@med.lu.se

Karin Svensson Söderberg, MD contact

karin.svensson-soderberg@kronoberg.se

Sweden2 sites, 2 recruiting
  • Ryd Vardcentral

    Ryd

    Karin Svensson Soderberg, MD

    Recruiting
  • Tingsryd Vardcentral

    Tingsryd

    Karin Svensson Soderberg, MD

    Recruiting

Other trials in Sweden

About this study

Official title: 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.

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).

Being tested
Heart age
Medical subject headings
Cardiovascular Diseases, Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Heart ageOther

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

Study groups in NCT05791279
Study groupRoleWhat they receive
Interventional armExperimentalThe 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.
Receives: Other: Heart age
Control armNo interventionThe 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Recruitment rate

    Number of patients being recruited within the specified time frame

    Measured: 6 months

  2. Dropout rate

    Number of patients who do not complete follow-up

    Measured: 6 months

  3. Quality

    Number of Heart Age estimations with adequate ECG signal quality

    Measured: 6 months

  4. Tolerability of the intervention

    Tolerability of the intervention assessed through questionnaires.

    Measured: 6 months

Secondary outcomes (10)
  1. Blood pressure (systolic and diastolic)

    Change in blood pressure

    Measured: 6 months

  2. HbA1c

    Change in HbA1c

    Measured: 6 months

  3. Physical activity

    Change in physical activity assessed through questionnaires.

    Measured: 6 months

  4. Dietary habits

    Change in dietary habits assessed through questionnaires.

    Measured: 6 months

  5. Tobacco

    Change in tobacco use assessed through questionnaires.

    Measured: 6 months

  6. Alcohol

    Change in alcohol use assessed through questionnaires.

    Measured: 6 months

  7. Medication adherence

    Change in medication adherence assessed through questionnaires.

    Measured: 6 months

  8. Risk perception

    Change in risk perception assessed through questionnaires.

    Measured: 6 months

  9. Body-mass index (BMI)

    Change in BMI

    Measured: 6 months

  10. Heart Age

    Change in Heart Age

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Mar 2023
  2. Study start1 May 2023
  3. Primary completion1 Sep 2024 (estimated)
  4. Study completion1 Sep 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05791279
Sponsor's protocol ID
Kronoberg_HA
Status last verified
Oct 2023
First submitted
20 Feb 2023
Last updated
11 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A study testing Heart age in people with Cardiovascular Diseases and Hypertension, run by Kronoberg County Council at 2 sites in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 11 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Thomas Lindow, MD, PhD (+46470588000, thomas.akesson_lindow@med.lu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recruitment rate (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05791279, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2023.

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