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

NCT05791279 | Unknown

• 1 other identifier: Kronoberg_HA
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Cardiovascular Diseases; Hypertension

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (10)

• Blood pressure (systolic and diastolic)

  6 months

• HbA1c

  6 months

• Physical activity

  6 months

• Dietary habits

  6 months

• Tobacco

  6 months

Study Arms (2)

Interventional arm

EXPERIMENTAL

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

Control arm

NO INTERVENTION

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

Heart age OTHER

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

Interventional arm

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kronoberg County Council: lead
• Lund University: collaborator
• University of Sydney: collaborator

Study Sites (2)

Ryd Vardcentral

Ryd, Sweden

RECRUITING

Tingsryd Vardcentral

Tingsryd, Sweden

RECRUITING

Related Publications (1)

• 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.

  PMID: 35701514 BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases; Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases

Study Officials

• Thomas Lindow, MD, PhD

  Region Kronoberg, Sweden; Lund University, Lund, Sweden

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas Lindow, MD, PhD

CONTACT

+46470588000; thomas.akesson_lindow@med.lu.se

Karin Svensson Söderberg, MD

CONTACT

karin.svensson-soderberg@kronoberg.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2023
• First Posted: March 30, 2023
• Study Start: May 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: October 11, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)