Knowledge of Vascular Age Contributes to Improve the Collaboration Between Community Pharmacies and Primary Health Care Physicians in Reducing Blood Pressure in Hypertensive Patients.

NCT06761235 | Not Yet Recruiting DMC

• 2 other identifiers: FP-1533-ROD-SAL-2024-01THCS: FP-1533
• Study Type: interventional
• Target: 1,246
• Locations: 3 countries
• Sites: 6

Brief Summary

Cardiovascular diseases are the main cause of death worldwide and elevated blood pressure (BP), called hypertension (HTN), is the principal and most frequent factor for suffering cardiovascular diseases. Recent studies show that approximately five out of 10 adults in Europe have increased BP or will develop HTN in their life-course. Unfortunately, screening programs for establishing the diagnosis of HTN do not exist. As a result, almost half of hypertensive patients do not know that their BP is elevated. Regarding the other half of subjects, who have been already diagnosed of HTN and are aware of their condition, up to 50% of them are not adequately controlled, although successful treatment of HTN is possible. There are several reasons explaining why at the end only one quarter of the hypertensive population achieves normal BP values. Firstly, there is a lack of patients´ adherence to the prescribed treatment. In other words, many patients do not take their pills as ordered, mostly because they do not realize the health risks associated with HTN, as elevated BP does not hurt nor lead to clinical symptoms. As a matter of fact, many hypertensive patients do not comply with their prescribed treatments. Secondly, the mere fact of prescribing drugs for reducing elevated BP is very often considered enough by the treating general practitioners, not having into account that the target blood pressure values are not achieved. This attitude is called therapeutic inertia. And thirdly, there is a lack of efficient communication between those specialized groups of health professionals, which are involved in the management of HTN, i.e. general practitioners and community pharmacies. In the context of high BP, the concept of early vascular aging (EVA), presented roughly 10 years ago, has been widely adopted since. The concept of vascular age generally refers to a way of expressing cardiovascular risk as an estimated age, considered useful for improving the understanding of cardiovascular risk in patients, especially in young patients, in whom standard information about health risks, such as the classical 10 year-risk derived from risk tables, is low and may transmit a false reassuring perception. \"Your arteries are 15 years older then you\" seems to make vascular age intuitively understood even by lay people. Vascular age has been shown to be easily estimated in community pharmacies in different countries and may contribute to increase HTN control. The goal of this clinical trial is to learn if increasing awareness of the consequences of elevated blood pressure by estimating vascular age of hypertensive patients in community pharmacies, and thus, empowering them, firstly, improves compliance with scheduled visits with general practitioners and secondly, increases hypertension control as measured by ambulatory blood pressure measurements (ABPM). The main questions it aims to answer are:

• Do hypertensive patients who know their vascular age comply better with scheduled visits to their general practitioners than hypertensive patients not aware of their vascular age?
• Does knowledge of vascular age improve the proportion of controlled HTN according to ABPM measurements after six months of state of the art treatment? Researchers will compare two groups of hypertensive patients.
• One half of the patients, the BP-arm, will receive usual educational sessions and standard, optimized advice.
• The so-called EVA-arm will get the same educational sessions and advice, but on top will be informed about their vascular age. After six months, ABPM will be repeated in both groups.
• The study will take place in Austria, Portugal and Spain. Participants:
• Participants are pharmacy customers who volunteered to participate.
• To enter the study, BP must be \> 140/90 mmHg in the pharmacy and \> 130/80 mmHg in the first ABPM.
• Recruitment and estimation of vascular age will take place in community pharmacies.
• Treatment will be established by the general physicians according to best clinical practice.
• The study will end after six months with a second measurement of ambulatory BP.

Conditions

Hypertension and Cardiovascular Risk Factors

Keywords

hypertension; Arterial stiffness; estimated Pulse Wave Velocity; Community Pharmacies; Primary Care; Vascular Age; Team-based Approach

Outcome Measures

Primary Outcomes (2)

• Proportion of patients in the EVA cohort who do comply with the visit to the Primary Care Physician compared to the proportion of patients in the BP cohort who do comply with the visit to the Primary Care Physician.

  Hypertensive patients will be randomized to the BP-cohort or the EVA-cohort. The hypothesis of the study is that the proportion of patients in the EVA-cohort who comply with the visit to the Primary Care Physician will be significantly higher than the proportion of patients in the BP-cohort who comply with the visit to the Primary Care Physician. Independent variables: Cohort \[BP/EVA\], Sex \[f/m\], Age \[years\], SBP \[mmHg\], DBP \[mmHg\], Smoker \[yes/no\], Heart rate \[beats/min\], Diabetes \[yes/no\], Obesity \[yes/no\], Pulse pressure (SBP - DBP) \[mmHg\], Prior CV event \[yes/no\]. In case of normal distribution of continuous variables but lack of variance homoscedasticity, Welch's t-test will be applied. For comparisons of continuous variables without normally distributed data and for comparisons of variables measured on ordinal scales, the Mann-Whitney U-test will be used. Dichotomous variables will be compared by the Fisher´s exact test, all other categorical variables by the chi-square test.

  Time between enrollment and diagnosis of hypertension in the community pharmacy and referral to the visit by the Primary Care Physician will be four weeks.

• Proportion of hypertensive patients in the EVA cohort who normalize blood pressure compared to the proportion of hypertensive patients in the BP cohort who normalize blood pressure as assessed by a second ABPM six months after the first ABPM.

  Hypertensive patients will be randomized to the BP-cohort or the EVA-cohort. The hypothesis of the study is that patients in the EVA-cohort who normalize BP in the second ABPM will be significantly higher than the proportion of patients in the BP-cohort who normalize BP as assessed in the second ABPM. Normal ABPM means ABPM 24-h \< 130/80 mmHg. Independent variables: Cohort \[BP/EVA\], Sex \[f/m\], Age \[years\], SBP \[mmHg\], DBP \[mmHg\], Smoker \[yes/no\], Heart rate \[beats/min\], Diabetes \[yes/no\], Obesity \[yes/no\], Pulse pressure (SBP - DBP) \[mmHg\], Prior CV event \[yes/no\]. In case of normal distribution of continuous variables but lack of variance homoscedasticity, Welch's t-test will be applied. For comparisons of continuous variables without normally distributed data and for comparisons of variables measured on ordinal scales, the Mann-Whitney U-test will be used. Dichotomous variables will be compared by the Fisher´s exact test, all other categorical variables by the chi-square test.

  Time between the first and the second ABPM will be six months

Secondary Outcomes (7)

• Change of 5 mmHg in systolic blood pressure and/or of 2 mmHg in diastolic blood pressure in the second ABPM

  Six months between first and second ABPM.

• Changes in lipid metabolism of cholesterol-LDL towards normalization.

  Six months.

• Change of body mass index (BMI) from obesity towards overweight or normal weight.

  Six months.

• Change in proportion of smokers who quit smoking.

  Six months.

• Changes in vascular risk stratification.

  Six months.

Study Arms (2)

Blood pressure arm (BP arm)

PLACEBO COMPARATOR

Optimized standard treatment for hypertensive patients

Diagnostic Test: Standard BP intervention

Early vascular aging arm (EVA arm)

EXPERIMENTAL

Optimized standard treatment for hypertensive patients plus information about individual vascular age assessed by brachial oscillometry

Diagnostic Test: EVA intervention

Interventions

Standard BP intervention DIAGNOSTIC_TEST

Behavioral: lifestyle counseling will be given according to international guidelines to reduce blood pressure.

Also known as: Ambulatory blood pressure monitoring to diagnose hypertension and educational sessions to empower hypertensive patients

Blood pressure arm (BP arm)

EVA intervention DIAGNOSTIC_TEST

Behavioral: lifestyle counseling will be given according to international guidelines to reduce blood pressure. In contrast to BP arm, EVA arm will additionally reciuve counseling about vascular age.

Also known as: Ambulatory blood pressure monitoring to diagnose hypertension plus estimated vascular age by brachial oscillometry and educational sessions to empower hypertensive patients

Early vascular aging arm (EVA arm)

Eligibility Criteria

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

You may qualify if:

• Age ≥18 years
• BP ≥ 140 mmHg and/or ≥ 90 mmHg in the pharmacy
• hour ABPM ≥ 130 mmHg or ≥ 80 mmHg
• Willingness to fill in forms, regarding
• Anamnesis (DM, hypercholesterolemia)
• Toxic habits
• Pharmacological groups of CV medication
• Previous CV diseases
• Data on GP and assigned Health Center
• Survey regarding interaction with GP and community pharmacist

You may not qualify if:

• Pregnancy
• Inability to understand the project (language barrier)
• Manifest incapacity or knowledge of the existence of a legal representative
• Factors preventing the correct measurement of BP/VA (arrhythmias, arm circumference, etc.)
• Previous measurement of VA in the last year

Sponsors & Collaborators

• Enrique Rodilla: lead
• Health Research Fund of ISCIII Spain: collaborator
• AIT Austrian Institute of Technology GmbH: collaborator
• Institut et Haute Ecole de la Santé la Source: collaborator
• Instituto Politécnico de Coimbra: collaborator
• European Union: collaborator

Study Sites (6)

Austrian Chamber of Pharmacists, Upper Austria (APO)

Linz, 4020, Austria

Location

Upper Austrian Society for General and Family Medicine (OBGAM)

Linz, 4020, Austria

Location

H&TRC - Health & Technology Research Center, Coimbra Health School, Polytechnic University of Coimbra

Coimbra, 3045-043, Portugal

Location

Hospital de Sagunto

Sagunto (valencia), Valencia, 46520, Spain

Location

Instituto Pluridisciplinar, Universidad Complutense de Madrid

Madrid, 28040, Spain

Location

Unidad de investigación de Atención Primaria de Salamanca (APISAL). Instituto de Investigación Biomédica de Salamanca (IBSAL)

Salamanca, 37007, Spain

Location

Related Publications (4)

• Danninger K, Hafez A, Binder RK, Aichberger M, Hametner B, Wassertheurer S, Weber T. High prevalence of hypertension and early vascular aging: a screening program in pharmacies in Upper Austria. J Hum Hypertens. 2020 Apr;34(4):326-334. doi: 10.1038/s41371-019-0222-y. Epub 2019 Jul 29.

  PMID: 31358883 BACKGROUND

• Pereira T, Paulino E, Maximiano S, Rosa M, Pinto AL, Mendes MJ, Brito J, Soares P, Risse J, Gose S. Measurement of arterial stiffness and vascular aging in community pharmacies-The ASINPHAR@2action project. J Clin Hypertens (Greenwich). 2019 Jun;21(6):813-821. doi: 10.1111/jch.13554. Epub 2019 May 16.

  PMID: 31095865 BACKGROUND

• Rodilla Sala E, Adell Alegre M, Giner Galvan V, Perseguer Torregrosa Z, Pascual Izuel JM, Climent Catala MT; en nombre del Grupo de estudio RIVALFAR. Arterial stiffness in normotensive and hypertensive subjects: Frequency in community pharmacies. Med Clin (Barc). 2017 Dec 7;149(11):469-476. doi: 10.1016/j.medcli.2017.04.037. Epub 2017 Jul 12. English, Spanish.

  PMID: 28709670 BACKGROUND

• Rodilla E, Adell M, Baixauli V, Bellver O, Castillo L, Centelles S, Hernandez R, Martinez S, Perseguer Z, Prats R, Ruiz D, Salar L, Climent M; COPHARTEN Study Group. Value of estimating pulse wave velocity compared to SCORE in cardiovascular risk stratification in community pharmacies. Med Clin (Barc). 2023 Dec 7;161(11):463-469. doi: 10.1016/j.medcli.2023.06.002. Epub 2023 Sep 19. English, Spanish.

  PMID: 37735046 BACKGROUND

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Thomas Weber, PhD, full Professor

  Cardiology Department, Klinikum Wels-Grieskirchen, Wels, Austria

  STUDY CHAIR

Central Study Contacts

Enrique Rodilla, PhD, full Professor

CONTACT

+34 626488311; rodilla_enr@gva.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: No other parties masked.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD, full Professor

Study Record Dates

• First Submitted: November 17, 2024
• First Posted: January 7, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 7, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: 01/JAN/2027 - 01/JAN/2028
• Access Criteria: Applicants will have to submit a proposal mentioning their goals and methodology to be granted access to the data and permission to reuse it. A data sharing agreement between the external party and the investigator will need to be agreed on and signed.

Locations

PT (1); AU (2); ES (3)