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Clinical Trials/NCT05791279
NCT05791279
Recruiting
Not Applicable

The Use of Electrocardiography-based Estimation of Heart Age to Improve Blood Pressure in a Primary Care Setting - a Pilot Study

Kronoberg County Council2 sites in 1 country60 target enrollmentMay 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiovascular Diseases
Sponsor
Kronoberg County Council
Enrollment
60
Locations
2
Primary Endpoint
Tolerability of the intervention
Status
Recruiting
Last Updated
2 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
May 1, 2023
End Date
September 1, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Kronoberg County Council
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Tolerability of the intervention

Time Frame: 6 months

Tolerability of the intervention assessed through questionnaires.

Dropout rate

Time Frame: 6 months

Number of patients who do not complete follow-up

Quality

Time Frame: 6 months

Number of Heart Age estimations with adequate ECG signal quality

Recruitment rate

Time Frame: 6 months

Number of patients being recruited within the specified time frame

Secondary Outcomes

  • HbA1c(6 months)
  • Tobacco(6 months)
  • Blood pressure (systolic and diastolic)(6 months)
  • Medication adherence(6 months)
  • Physical activity(6 months)
  • Dietary habits(6 months)
  • Body-mass index (BMI)(6 months)
  • Alcohol(6 months)
  • Risk perception(6 months)
  • Heart Age(6 months)

Study Sites (2)

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