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

NCT04433052 · tracked via the Priya Life Science Germany tracker

Sponsor

Tampere University

Phase

Not applicable

Started

2023-02-01

Last updated

2023-06-12

Condition(s) studied

Coronary Heart Disease

Investigational drug(s) / intervention(s)

personalised prevention program (PPP)

personalised prevention program (PPP): 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 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 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

Eligibility

Sex

ALL

Min age

30 Years

Max age

80 Years

Healthy volunteers

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.

Primary outcome measure(s)

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 — 3 years follow-up
• 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.

Trial sites (26)

Facility	City	Region	Status
Helsinki University Hospital	Helsinki	Finland	Recruiting
Mehiläinen	Helsinki	Finland	Recruiting
Kuopio University Hospital	Kuopio	Finland	Not Yet Recruiting
Oulu University Hospital	Oulu	Finland	Recruiting
Klinik am See	Berlin	Germany	Not Yet Recruiting
CCV-MVZ	Frankfurt	Germany	Withdrawn
Heidelberg University	Mannheim	Germany	Not Yet Recruiting
Technise Universität Munchen	München	Germany	Not Yet Recruiting
Herzklinik Ulm	Ulm	Germany	Not Yet Recruiting
Hellenic Red Cross Hospital	Athens	Greece	Not Yet Recruiting
Konstantopoulio Hospital	Athens	Greece	Not Yet Recruiting
Sismanoglion Hospital	Athens	Greece	Not Yet Recruiting
The Biomedical Research Foundation of the Academy Athens	Athens	Greece	Not Yet Recruiting
University Hospital Genova	Genova	Italy	Not Yet Recruiting
Multi Medica, Care and Research Institute	Milan	Italy	Not Yet Recruiting
Casilino Hospital Rome	Rome	Italy	Not Yet Recruiting
University Hospital Turin	Turin	Italy	Not Yet Recruiting
University of Bialystok	Bialystok	Poland	Not Yet Recruiting
Medical University of Silesia	Katowice	Poland	Not Yet Recruiting
Jagellonian University Medical College	Krakow	Poland	Not Yet Recruiting
University of Lublin	Lublin	Poland	Not Yet Recruiting
Nicolaus Copernicus University	Toruniak	Poland	Not Yet Recruiting
National Institute of Cardiology	Warsaw	Poland	Not Yet Recruiting
Hospital de Santa Cruz-CHLO	Carnaxide	Portugal	Not Yet Recruiting
Hospital do Espirito Santo	Lisbon	Portugal	Not Yet Recruiting
Hospital Santa Maria-CHULN/FMUL	Lisbon	Portugal	Not Yet Recruiting

Other trials for the same condition

Hamburg City Health Study - a German Cohort Study Recruiting

Clinical Study for the Investigation and Validation of a Therapy Procedure for the Adjustment of Risk Factors in Patients With Coronary Heart Disease by Means of Digital Therapy Control Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04433052 on ClinicalTrials.gov ↗ ← All trials in Germany