AzTrials
AzTrials

Coronary Heart DiseaseNCT04433052

Clinical Value and Cost-effectiveness of a Personalized Prevention Program (PPP) in Patients With High Risk Stable CHD

A study testing personalised prevention program (PPP) in people with Coronary Heart Disease, run by Tampere University at 26 sites in 6 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Prospective clinical study with two parts: PART A: a prospective biomarker-based risk screening study in coronary heart disease (CHD) subjects PART B: a nested randomized clinical trial (RCT) in an enriched subpopulation of high-risk stable CHD subjects PART A: 12 000 subjects with stable CHD PART B: 2000 subjects… Read more about this study

Who is it for?
Ages 30 to 80 years
Conditions the study is for
Coronary Heart Disease
What is being tested?
personalised prevention program (PPP)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12,000 participants
Where
26 sitesin 6 countries
Study dates
1 Feb 2023to Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 30 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Eligible study subjects must meet all of the following inclusion criteria:

  1. Informed consent form signed by the study subjects.
  2. Male or female aged 30 to 80 years on the day of enrolment.
  3. > 50% stenosis in one or more major coronary arteries on angiography or computerised tomography (CT) performed within the preceding one year (from enrolment visit). or Myocardial infarction (type I, II) during the preceding year.

Eligible study subjects must not meet any of the following exclusion criteria:

  1. Hospitalisation for acute coronary syndrome, myocardial infarction, stroke, coronary revascularisation or acute heart failure within the preceding one month (30 days). These subjects can be enrolled after a one-month stabilisation period, which begins from the time of the event.
  2. Subjects with NYHA class III-IV heart failure i.e. marked limitation in activity due to symptoms, comfortable only at rest.
  3. Uncontrolled arrhythmias such as ventricular tachycardias.
  4. Subjects undergoing dialysis due to severe renal disease.
  5. Diseases that severely disable exercising (per investigator's judgement), such as rheumatoid arthritis, neurological or orthopaedic diseases.
  6. Known aplastic or haemolytic anaemia.
  7. Concomitant non-coronary disease, such as malignancy that limits life expectancy to less than three years.
  8. Concurrent participation in another interventional study.
  9. Subjects not able and/or willing to attend all scheduled visits and comply with all study procedures and use a smartphone application.

Trial locations and contacts

26 sites in 6 countries. Contact the study team or a site near you to ask about taking part.

Hanna Marttila, MSc contact

+358407240771

hanna.marttila@tuni.fi

26 sites in 6 countries

Poland6 sites, 6 recruiting

  • University of Bialystok

    Bialystok

    Karol Kaminski, MD, PhD

    Not yet recruiting

  • Medical University of Silesia

    Katowice

    Zbigniew Gasior, MD, PhD, zgasior@ptkardio.pl

    Not yet recruiting

  • Jagellonian University Medical College

    Krakow

    Piotor Jankowski, MD, PhD, piotrjankowski@interia.pl

    Not yet recruiting

  • University of Lublin

    Lublin

    Andrzej Wysokinski, MD, PhD

    Not yet recruiting

  • Nicolaus Copernicus University

    Toruniak

    Aldona Kubica, MD, PhD

    Not yet recruiting

  • National Institute of Cardiology

    Warsaw

    Rafal Dabrowski, MD, PhD

    Not yet recruiting

Other trials in Poland

Germany5 sites, 4 recruiting

  • Klinik am See

    Berlin

    Heinz Völler, MD, PhD

    Not yet recruiting

  • CCV-MVZ

    Frankfurt

    Withdrawn

  • Heidelberg University

    Mannheim

    Winfried März, MD, PhD

    Not yet recruiting

  • Technise Universität Munchen

    München

    Martin Halle, MD, PhD

    Not yet recruiting

  • Herzklinik Ulm

    Ulm

    Ralf Birkemeyer, MD, PhD

    Not yet recruiting

Other trials in Germany

Finland4 sites, 4 recruiting

  • Helsinki University Hospital

    Helsinki

    Juha Sinisalo, MD, PhD, juha.sinisalo@hus.fi

    Recruiting

  • Mehiläinen

    Helsinki

    Kristiina Hotakainen, MD, PhD, Kristina.Hotakainen@mehilainen.fi

    Recruiting

  • Kuopio University Hospital

    Kuopio

    Juha Hartikainen, MD, PhD, juha.hartikainen@kuh.fi

    Not yet recruiting

  • Oulu University Hospital

    Oulu

    Janne Hukkanen, MD, PhD, janne.hukkanen@ppshp.fi

    Recruiting

Other trials in Finland

Greece4 sites, 4 recruiting

  • Hellenic Red Cross Hospital

    Athens

    Nikolaos Bourmpoulis, MD, PhD

    Not yet recruiting

  • Konstantopoulio Hospital

    Athens

    Patsilinakos Sotirios, MD, PhD

    Not yet recruiting

  • Sismanoglion Hospital

    Athens

    Dimitrios Sionis, MD, PhD

    Not yet recruiting

  • The Biomedical Research Foundation of the Academy Athens

    Athens

    Constantinos Davos, MD, PhD, cdavos@bioacademy.gr

    Not yet recruiting

Other trials in Greece

Italy4 sites, 4 recruiting

  • University Hospital Genova

    Genova

    Itolo Porto, MD, PhD, italo.porto@unige.it

    Not yet recruiting

  • Multi Medica, Care and Research Institute

    Milan

    Roberto FE Pedretti, MD, PhD

    Not yet recruiting

  • Casilino Hospital Rome

    Rome

    Leonardo Calo, MD, PhD

    Not yet recruiting

  • University Hospital Turin

    Turin

    Gaetano de Ferrari, MD, PhD, gaetanomaria.deferrari@unito.it

    Not yet recruiting

Other trials in Italy

Portugal3 sites, 3 recruiting

  • Hospital de Santa Cruz-CHLO

    Carnaxide

    Miguel Mendes, MD, PhD

    Not yet recruiting

  • Hospital do Espirito Santo

    Lisbon

    Lino Patricio, MD, PhD

    Not yet recruiting

  • Hospital Santa Maria-CHULN/FMUL

    Lisbon

    Ana Abreu, MD, PhD, ananabreu@hotmail.com

    Not yet recruiting

Other trials in Portugal

About this study

Official title: A Prospective Clinical Trial to Evaluate the Clinical Value and Cost-effectiveness of a Personalized Prevention Program in Patients With High Risk Stable Coronary Heart Disease

Prospective clinical study with two parts:

PART A: a prospective biomarker-based risk screening study in coronary heart disease (CHD) subjects PART B: a nested randomized clinical trial (RCT) in an enriched subpopulation of high-risk stable CHD subjects

PART A: 12 000 subjects with stable CHD

PART B: 2000 subjects with high risk of CV events will be randomized to usual care (UC) or personalised prevention program (PPP) i.e. 1000 subjects per arm.

Study purpose is to assess the clinical value and cost-effectiveness of a personalised prevention program (PPP) in high-risk, stable coronary heart disease (CHD) subjects and to prospectively validate risk screening biomarkers

Read the detailed description

Primary Objectives:

PART A:

  • To prospectively validate biomarkers in risk stratification among stable CHD subjects, i.e. evaluation of the biomarker performance in accurately predicting CV events including CV death, nonfatal MI, HF events
  • To identify high-risk CHD subjects for the subsequent RCT, i.e. 15-20% of the screened patient population at the highest risk

PART B

  • To demonstrate whether a personalised prevention (PPP) strategy in high-risk CHD subjects results in a decreased risk of cardiovascular (CV) events (CV death, nonfatal myocardial infarction (MI) or heart failure (HF) events) as compared to the local usual care (UC)

Secondary Objectives:

  • To evaluate the difference between the PPP arm to the UC arm as listed in section outcomes.
  • To evaluate the health economic value of the PPP
  • To prospectively study associations (in all enrolled subjects) between separate biomarkers (CERT2, hs-troponin, proBNP, Cystatin C) or their score (CoroPredict)

In addition to the above-listed primary and secondary objectives of the study, the following analysis will be carried out based on the data to be collected during the trial:

  • Effect of personalised prevention on behavioural change.
  • Effect of behavioural change on CV outcomes and blood pressure.
  • Identification of key components and risk factors affecting effectiveness of the PPP.
  • Inter-relationship between nutrition and exercise will be evaluated. Nutrition parameters will be based on questionnaires and biomarkers (Trimethylamine N-oxide (TMAO), Trimethyllysine (TML), carnitines and their metabolites).
  • Effect of the use of the CoroPrevention Tool Suite (EXPERT tool) on the agreement between exercise prescriptions generated by cardiovascular nurses to subjects with CVD, and the ESC guideline-directed exercise prescriptions
  • Effect of greater adherence to EXPERT tool-driven exercise prescriptions by clinicians and subjects, on CVD risk, physical fitness, and prognosis (hospitalisations, adverse events, mortality) in subjects with CVD.
  • Effect of the use of the EXPERT tool-driven medication decision support system on the agreement between medication prescriptions generated by cardiovascular nurses to subjects with CVD, and the ESC guideline-directed medication prescriptions
  • Effect of better adherence by both clinicians and subjects to ESC guideline prescriptions, driven by the medication decision support system within the EXPERT tool, on CVD risk and prognosis (hospitalisations, adverse events, mortality) in subjects with CVD.
  • Investigation of the user experience and user acceptance of the CoroPrevention Tool Suite.
Being tested
personalised prevention program (PPP)
Keywords
Prevention, Coronary Heart Disease, Biomarkers, Lifestyle
Medical subject headings
Coronary Disease

What participants receive

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

  • personalised prevention program (PPP)Behavioural

    Study subjects in the PPP arm will be invited to return to the study site six times over a three-year period (at V2/start of the study, V3/mo2, V4/mo6, V5/mo12, V6/mo18 and V7/mo36) to receive lifestyle coaching and exercise prescriptions led by a delegated member of the site staff and supervised by the investigator. Information on drug treatment will also be given by the investigator. These activities will be assisted by digital tools specifically designed for this study, the CoroPrevention Tool Suite.

Study groups in NCT04433052
Study groupRoleWhat they receive
Personalised prevention program (PPP)ExperimentalParticipants will be invited to return to the study site six times over a three year period to receive lifestyle coaching and exercise prescriptions. Eupropean Society of Cardiology/European Association of Preventive Cardiology (ESC/EAPC) -designed lifestyle counselling will be partially delivered by novel smartphone applications. Participants will also receive pharmaceutical treatment according to the ESC guideline for chronic coronary syndromes.
Receives: Behavioral: personalised prevention program (PPP)
Usual care (UC)No interventionParticipants will be referred back to usual care provided by their treating physicians. It is anticipated that physicians will treat these participants according to local usual medical practices. Patients randomized to UC group will not receive any treatment recommendations nor restrictions by the study investigators or nurses. Randomized UC patients are invited to site visits twice over a three year period.

What is being measured

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

  1. To demonstrate whether a PPP strategy in high-risk CHD subjects results in a decreased risk of CV events (CV death, nonfatal MI or HF events) compared to the UC

    • The time from randomisation to the occurrence of the first CV event included in the composite endpoint of the study (CV death, nonfatal MI, HF events) over 3 years follow-up.

    Measured: 3 years follow-up

Secondary outcomes (7)

  1. To evaluate the difference between PPP arm to the UC arm in

    • The times from randomisation to the occurrence of the specific items included in the composite endpoint (CV death, nonfatal MI, HF event) over 3 years follow-up

    Measured: 3 years follow-up

  2. To evaluate the difference between PPP arm to the UC arm in

    • The times from randomisation to the occurrence of secondary CV events (unstable angina, stroke and coronary revascularisations excluding those elective revascularisations that have been planned prior to randomisation)

    Measured: 3 years follow-up

  3. To evaluate the difference between PPP arm to the UC arm in

    • Treatment adherence; measured by compliance laboratory assessments and in the PPP group, also with activity reports

    Measured: 3 years follow-up

  4. To evaluate the difference between PPP arm to the UC arm in

    All-cause mortality

    Measured: 3 years follow-up

  5. To evaluate the difference between PPP arm to the UC arm in

    Incidence of additional clinical endpoints: diabetes mellitus type 2 (DM2), chronic kidney disease (CKD), peripheral artery disease (PAD) and hypertension

    Measured: 3 years follow-up

  6. To evaluate the health economic value of the PPP

    • A cost-effectiveness analysis of PPP versus UC will be undertaken, based on evidence from the randomised clinical trial (RCT) portion of the study, using within-trial analysis and long-term cost-effectiveness modelling for the six countries participating in the CoroPrevention trial: Finland, Poland, Greece, Portugal, Italy, and Germany.

    Measured: 3 years follow-up

  7. • To prospectively study associations (in all enrolled subjects) between separate risk biomarkers (CERT2, hs-troponin , proBNP, Cystatin C) or their score (CoroPredict) and

    • Primary composite CV event (CV death, MI, HF events)
    • Specific CV events (CV death, nonfatal MI, HF events) separately
    • Specific secondary CV events (unstable angina, stroke, coronary revascularisations)
    • Incidence of DM2, CKD, PAD and hypertension

    Measured: 3 years follow-up

Timeline

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

  1. First posted16 Jun 2020
  2. Study start1 Feb 2023
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (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
12,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04433052
Sponsor's protocol ID
CPP-2020-1
Status last verified
Jun 2023
First submitted
4 Jun 2020
Last updated
12 Jun 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: EU open access policy

Questions about this trial

What is this clinical trial studying?

A study testing personalised prevention program (PPP) in people with Coronary Heart Disease, run by Tampere University at 26 sites in 6 countries.

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

Who may be eligible to take part?

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: looking for participants now, as of the sponsor's last update on 12 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in Poland, Germany, Finland, Greece, Italy and 1 more country. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Hanna Marttila, MSc (+358407240771, hanna.marttila@tuni.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To demonstrate whether a PPP strategy in high-risk CHD subjects results in a decreased risk of CV events (CV death, nonfatal MI or HF events) compared to the UC (time frame: 3 years follow-up). 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 NCT04433052.

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 12 Jun 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in