ExerciseMuCAYAplusNCT06259617
The Munich Cardiovascular Adaptation in Young Athletes Plus Study
An observational study of Exercise, run by Technical University of Munich at 1 site in Germany.
Trial summary
The aim of the 3-year longitudinal study is to investigate the cardiovascular system's response to training loads in young athletes. For the first time, these parameters will be examined alongside biochemical and metabolic laboratory measures, as well as body composition. Read more about this study
- Who is it for?
- Ages 7 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise
- How many people
- 250 participants
- Where
- 1 siteGermany
- Study dates
- 1 Dec 2023to Sep 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 7 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Participants aged ≥7 and <18 years, which are participating in athletic competitions, engage in regular training in a primary sport and are members of a club and/or association, with a training load of ≥3 hours per week The participants are recruited at the Pediatric Sports Medicine Outpatient Clinic at the Chair of Preventive Pediatrics. Children and adolescents voluntarily present themselves for sports fitness examinations, either for their competitive activities or as a requirement. These include young athletes who have been examined in previous years or those undergoing a sports fitness examination for the first time.
Who may be able to join
- Participants aged ≥7 and <18 years, presenting for sports medical examination and meeting the criteria mentioned for a period of 3 years
- Athletes participating in competitions, engaging in regular training in a primary sport, being members of a club or association, and training ≥3 hours per week
- The last intensive training must have occurred 12 hours ago to ensure sufficient recovery
- No acute infection, confirmed by a medical examination on the day of testing
- No orthopedic injury, confirmed by a medical examination on the day of testing
- No chronic disease, confirmed by a medical examination on the day of testing
Show all 9Show fewer
- Clearance for cardiopulmonary stress testing after a medical examination on the day of testing
- Annual participation (1 time per year) in the sports medical examination for 3 years
- Maintaining regular training, training duration ≥3 hours per week, and participation in competitions
Who cannot join
- Presence of an acute infection, acute orthopedic injury, or chronic disease
- Missing consent from the participant and/or legal guardian
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Sportmedizinische Ambulanz für Kinder und Jugendliche
München, Bavaria, 80992
Tobias Engl, Dipl. Sportwiss. Univ., +49 89 289 24598, tobias.engl@tum.de
Jonas Haferanke, M.Sc., +49 89 289 24579, jonas.haferanke@tum.de
About this study
Official title: Influence of Vigorous Physical Activity and Metabolic Parameters on Structure and Function of the Cardiovascular System in Young Athletes - the MuCAYAplus - Study (Munich Cardiovascular Adaptation in Young Athletes Study)
The aim of the 3-year longitudinal study is to investigate the cardiovascular system's response to training loads in young athletes. For the first time, these parameters will be examined alongside biochemical and metabolic laboratory measures, as well as body composition. The study focuses on the impact of training frequency and intensity, as well as performance, on cardiovascular structure and function.
The following research questions are being investigated:
Read more
What structural and functional cardiovascular changes can be observed in young athletes compared to the norm?
What is the relationship between cardiac and vascular parameters depending on the athletic load (training frequency and intensity) as well as athletic performance?
Do cardiac/vascular parameters change over the course of the study, and what role do athletic load (training frequency and intensity) as well as athletic performance play?
What laboratory chemical changes can be observed in young athletes depending on the athletic load (training frequency and intensity) as well as athletic performance?
What connections exist between laboratory chemical parameters and cardiac and vascular parameters in young athletes?
Is there a correlation between structural and functional cardiovascular changes and body composition as well as eating behavior?
- Conditions
- Exercise
- Keywords
- Adolescents, Children, Exercise, Physical Activity, Vascular adaptation, Cardial adaptation, Carotid Intima-Media-Thickness, Pulse Wave Velocity, Blood pressure, Athletic performance, Nutritional status, Body composition, Biomarkers
- Medical subject headings
- Motor Activity
What is being measured
The primary outcome is the main question the study is designed to answer.
Vascular stiffness
Vascular stiffness of the A. carotis communis, sonographic assessment, result in (%) strain
Measured: Once every year over 3 years
Peripheral and central blood pressure
Assessment via blood pressure cuff, result in (mmHg)
Pulse Wave Velocity
Measured: Once every year over 3 years
Left Ventricular internal end diastolic diameter (LVIDd)
Echocardiographic assessment, result in (mm)
Measured: Once every year over 3 years
Left ventricular posterior wall end diastole (LVPWd)
Echocardiographic assessment, result in (mm)
Measured: Once every year over 3 years
Interventricular septum thickness (IVSd)
Echocardiographic assessment, result in (mm)
Measured: Once every year over 3 years
Left ventricular mass (LVM)
Echocardiographic assessment, result in (g)
Measured: Once every year over 3 years
Relative wall thickness (RWT)
Echocardiographic assessment, result in (mm)
Measured: Once every year over 3 years
Ejection fraction (EF)
Echocardiographic assessment, result in (%)
Measured: Once every year over 3 years
Fractional shortening (FS)
Echocardiographic assessment, result in (%)
Measured: Once every year over 3 years
Left ventricular diastolic function (E', E/E', A', E'/A', E-Wave, A-Wave, E/A)
Echocardiographic assessment, result in (cm/s)
Measured: Once every year over 3 years
Left ventricular systolic function (S', S)
Echocardiographic assessment, result in (cm/s)
Measured: Once every year over 3 years
Left Atrial Diameter and Right Atrial Diameter and Diameter/Body Surface Area
Echocardiographic assessment, result in (cm)
Measured: Once every year over 3 years
Left Atrial and Right Atrial Volume/Body Surface Area
Echocardiographic assessment, result in (ml/m²)
Measured: Once every year over 3 years
Left atrial peak longitudinal strain (L-PALS)
Echocardiographic assessment, result in (%)
Measured: Once every year over 3 years
Left atrial peak contraction strain (L-PACS)
Echocardiographic assessment, result in (%)
Measured: Once every year over 3 years
Left atrial total strain
Echocardiographic assessment, result in (%)
Measured: Once every year over 3 years
Right atrial peak longitudinal strain (R-PALS)
Echocardiographic assessment, result in (%)
Measured: Once every year over 3 years
Right atrial peak contraction strain (R-PACS)
Echocardiographic assessment, result in (%)
Measured: Once every year over 3 years
Global longitudinal strain (GLS)
Echocardiographic assessment, result in (%)
Measured: Once every year over 3 years
Intima-Media-Thickness (IMT)
Intima-Media-Thickness (IMT) of the A. carotis communis, sonographic assessment, result in (mm)
Measured: Once every year over 3 years
Peripheral and central pulse pressure
Assessment via blood pressure cuff, result in (mmHg)
Measured: Once every year over 3 years
Pulse Wave Velocity
Assessment via blood pressure cuff, result in (ms)
Measured: Once every year over 3 years
Secondary outcomes (43)
Physical Fitness
Spiroergometric measure of VO2max
Measured: Once every year over 3 years
Nutritional Status
Assessment of dietary habits and nutritional status via the validated Healthy Eating Index (HEI).Originally developed in the USA, it was adapted to the German recommendations on food consumption.Higher scores are associated with higher compliance with the official diet recommendations.
Measured: Once every year over 3 years
Training Frequency
Assessment of training frequency via the MoMo activity questionnaire, result in (minutes/week)
Measured: Once every year over 3 years
Medical history
Current illnesses/injuries,Vaccination status, Allergies, Medication, Dietary supplements, Alcohol- and nicotine consumption, Drug use, Energy Drinks, Dietary Habits, Menarche and menstrual cycle in girls Family history of cardiovascular diseases, Unclear deaths, Sudden cardiac death, Marfan syndrome Training history, Symptoms during exercise such as shortness of breath, dizziness/syncope, palpitations or chest pain
Measured: Once every year over 3 years
Height
Measured via Stadiometer, result in (cm)
Measured: Once every year over 3 years
Weight
Measured on scale, result in (kg)
Measured: Once every year over 3 years
Body-Mass-Index
Calculated from Heigt and Weight, result in (kg/m²)
Measured: Once every year over 3 years
Bodyfat percentage
Measured via bioelectric impedance scale, result in (%)
Measured: Once every year over 3 years
Fat mass
Measured via bioelectric impedance scale, result in (kg)
Measured: Once every year over 3 years
Fat-free mass
Measured via bioelectric impedance scale, result in (kg)
Measured: Once every year over 3 years
Muscle mass
Measured via bioelectric impedance scale, result in (kg)
Measured: Once every year over 3 years
Water content
Measured via bioelectric impedance scale, result in (L)
Measured: Once every year over 3 years
Waist circumference
Measured via measuring tape, result in (cm)
Measured: Once every year over 3 years
Hip circumference
Measured via measuring tape, result in (cm)
Measured: Once every year over 3 years
Sitting height (cm)
Measured via Stadiometer, result in (cm)
Measured: Once every year over 3 years
Erythrocytes
Venous blood sampling and laboratory analysis, result in (/pL),
Measured: Once every year over 3 years
GOT (AST)
Venous blood sampling and laboratory analysis, result in (U/L)
Measured: Once every year over 3 years
GPT (ALT)
Venous blood sampling and laboratory analysis, result in (U/L)
Measured: Once every year over 3 years
GGT
Venous blood sampling and laboratory analysis, result in (U/L)
Measured: Once every year over 3 years
Cholesterol
Venous blood sampling and laboratory analysis, result in (mg/dL)
Measured: Once every year over 3 years
HDL-Cholesterol
Venous blood sampling and laboratory analysis, result in (mg/dL)
Measured: Once every year over 3 years
Non-HDL (calc.)
Venous blood sampling and laboratory analysis, result in (mg/dL)
Measured: Once every year over 3 years
LDL-Cholesterol
Venous blood sampling and laboratory analysis, result in (mg/dL)
Measured: Once every year over 3 years
Creatinine
Venous blood sampling and laboratory analysis, result in (mg/dL)
Measured: Once every year over 3 years
Uric acid
Venous blood sampling and laboratory analysis, result in (mg/dL)
Measured: Once every year over 3 years
hsCRP
Venous blood sampling and laboratory analysis, result in (mg/dL)
Measured: Once every year over 3 years
fT3
Venous blood sampling and laboratory analysis, result in (pg/mL)
Measured: Once every year over 3 years
Glutathion peroxidase
Venous blood sampling and laboratory analysis, result in (U/L)
Measured: Once every year over 3 years
Superoxide dismutase
Venous blood sampling and laboratory analysis, result in (U/mL)
Measured: Once every year over 3 years
Endothelin-1
Venous blood sampling, blood plasma preparation and laboratory analysis, result in (pg/mL)
Measured: Once every year over 3 years
Nitric Oxide
Venous blood sampling, blood plasma preparation and laboratory analysis, result in (μmol/L)
Measured: Once every year over 3 years
Ferritin
Venous blood sampling, blood plasma preparation and laboratory analysis, result in (ng/mL)
Measured: Once every year over 3 years
Leptin
Venous blood sampling, blood plasma preparation and laboratory analysis, result in (ng/mL)
Measured: Once every year over 3 years
Training intensity
Assessment of training intensity via the MoMo activity questionnaire, result in (metabolic equivalent task-minutes/week)
Measured: Once every year over 3 years
Hemoglobin
Venous blood sampling and laboratory analysis, result in (g/dL)
Measured: Once every year over 3 years
HBE/MCH
Venous blood sampling and laboratory analysis, result in (pg)
Measured: Once every year over 3 years
MCV
Venous blood sampling and laboratory analysis, result in (fL)
Measured: Once every year over 3 years
Hematocrit
Venous blood sampling and laboratory analysis, result in (%)
Measured: Once every year over 3 years
MCHC
Venous blood sampling and laboratory analysis, result in (g/dL)
Measured: Once every year over 3 years
RDW (Ery)
Venous blood sampling and laboratory analysis, result in (%)
Measured: Once every year over 3 years
Thrombocytes
Venous blood sampling and laboratory analysis, result in (Tsnd/µL)
Measured: Once every year over 3 years
Leukocytes
Venous blood sampling and laboratory analysis, result in (/nL)
Measured: Once every year over 3 years
Heart Rate
Assessment via blood pressure cuff, result in (bpm)
Measured: Once every year over 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start1 Dec 2023
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ExerciseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- German Research Foundation
- Responsible party
- Sponsor
- Investigators
- Thorsten Schulz, Dr., Principal investigator, Technical University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06259617
- Sponsor's protocol ID
- 516547656
- Acronym
- MuCAYAplus
- Status last verified
- Feb 2024
- First submitted
- 26 Jan 2024
- Last updated
- 14 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Baumgartner L, Schulz T, Oberhoffer R, Weberruss H. Influence of Vigorous Physical Activity on Structure and Function of the Cardiovascular System in Young Athletes-The MuCAYA-Study. Front Cardiovasc Med. 2019 Oct 9;6:148. doi: 10.3389/fcvm.2019.00148. eCollection 2019.
PubMed 31649936
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Vigorous Physical Activity and Metabolic Parameters on Structure and Function of the Cardiovascular System in Young Athletes - the MuCAYAplus - Study (Munich Cardiovascular Adaptation in Young Athletes Study)
- ClinicalTrials.gov ID
- NCT06259617
- Acronym / sponsor ID
- MuCAYAplus / 516547656
- Conditions
- Exercise
- Keywords
- Adolescents, Children, Exercise, Physical Activity, Vascular adaptation, Cardial adaptation, Carotid Intima-Media-Thickness, Pulse Wave Velocity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Collaborators
- German Research Foundation
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 14 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the 3-year longitudinal study is to investigate the cardiovascular system's response to training loads in young athletes. For the first time, these parameters will be examined alongside biochemical and metabolic laboratory measures, as well as body composition. The study focuses on the impact of training frequency and intensity, as well as performance, on cardiovascular structure and function.
The following research questions are being investigated:
What structural and functional cardiovascular changes can be observed in young athletes compared to the norm?
What is the relationship between cardiac and vascular parameters depending on the athletic load (training frequency and intensity) as well as athletic performance?
Do cardiac/vascular parameters change over the course of the study, and what role do athletic load (training frequency and intensity) as well as athletic performance play?
What laboratory chemical changes can be observed in young athletes depending on the athletic load (training frequency and intensity) as well as athletic performance?
What connections exist between laboratory chemical parameters and cardiac and vascular parameters in young athletes?
Is there a correlation between structural and functional cardiovascular changes and body composition as well as eating behavior?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Participants aged ≥7 and <18 years, which are participating in athletic competitions, engage in regular training in a primary sport and are members of a club and/or association, with a training load of ≥3 hours per week The participants are recruited at the Pediatric Sports Medicine Outpatient Clinic at the Chair of Preventive Pediatrics. Children and adolescents voluntarily present themselves for sports fitness examinations, either for their competitive activities or as a requirement. These include young athletes who have been examined in previous years or those undergoing a sports fitness examination for the first time.
Key inclusion criteria (9 listed)
- Participants aged ≥7 and <18 years, presenting for sports medical examination and meeting the criteria mentioned for a period of 3 years
- Athletes participating in competitions, engaging in regular training in a primary sport, being members of a club or association, and training ≥3 hours per week
- The last intensive training must have occurred 12 hours ago to ensure sufficient recovery
- No acute infection, confirmed by a medical examination on the day of testing
- No orthopedic injury, confirmed by a medical examination on the day of testing
Key exclusion criteria (2 listed)
- Presence of an acute infection, acute orthopedic injury, or chronic disease
- Missing consent from the participant and/or legal guardian
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Vascular stiffness
Time frame: Once every year over 3 years
Vascular stiffness of the A. carotis communis, sonographic assessment, result in (%) strain
Peripheral and central blood pressure
Time frame: Once every year over 3 years
Assessment via blood pressure cuff, result in (mmHg) Pulse Wave Velocity
Left Ventricular internal end diastolic diameter (LVIDd)
Time frame: Once every year over 3 years
Echocardiographic assessment, result in (mm)
Left ventricular posterior wall end diastole (LVPWd)
Time frame: Once every year over 3 years
Echocardiographic assessment, result in (mm)
Interventricular septum thickness (IVSd)
Time frame: Once every year over 3 years
Echocardiographic assessment, result in (mm)
Left ventricular mass (LVM)
Time frame: Once every year over 3 years
Echocardiographic assessment, result in (g)
Relative wall thickness (RWT)
Time frame: Once every year over 3 years
Echocardiographic assessment, result in (mm)
Ejection fraction (EF)
Time frame: Once every year over 3 years
Echocardiographic assessment, result in (%)
Fractional shortening (FS)
Time frame: Once every year over 3 years
Echocardiographic assessment, result in (%)
Left ventricular diastolic function (E', E/E', A', E'/A', E-Wave, A-Wave, E/A)
Time frame: Once every year over 3 years
Echocardiographic assessment, result in (cm/s)
Left ventricular systolic function (S', S)
Time frame: Once every year over 3 years
Echocardiographic assessment, result in (cm/s)
Left Atrial Diameter and Right Atrial Diameter and Diameter/Body Surface Area
Time frame: Once every year over 3 years
Echocardiographic assessment, result in (cm)
Left Atrial and Right Atrial Volume/Body Surface Area
Time frame: Once every year over 3 years
Echocardiographic assessment, result in (ml/m²)
Left atrial peak longitudinal strain (L-PALS)
Time frame: Once every year over 3 years
Echocardiographic assessment, result in (%)
Left atrial peak contraction strain (L-PACS)
Time frame: Once every year over 3 years
Echocardiographic assessment, result in (%)
Left atrial total strain
Time frame: Once every year over 3 years
Echocardiographic assessment, result in (%)
Right atrial peak longitudinal strain (R-PALS)
Time frame: Once every year over 3 years
Echocardiographic assessment, result in (%)
Right atrial peak contraction strain (R-PACS)
Time frame: Once every year over 3 years
Echocardiographic assessment, result in (%)
Global longitudinal strain (GLS)
Time frame: Once every year over 3 years
Echocardiographic assessment, result in (%)
Intima-Media-Thickness (IMT)
Time frame: Once every year over 3 years
Intima-Media-Thickness (IMT) of the A. carotis communis, sonographic assessment, result in (mm)
Peripheral and central pulse pressure
Time frame: Once every year over 3 years
Assessment via blood pressure cuff, result in (mmHg)
Pulse Wave Velocity
Time frame: Once every year over 3 years
Assessment via blood pressure cuff, result in (ms)
43 secondary outcomes
Physical Fitness
Time frame: Once every year over 3 years
Nutritional Status
Time frame: Once every year over 3 years
Training Frequency
Time frame: Once every year over 3 years
Medical history
Time frame: Once every year over 3 years
Height
Time frame: Once every year over 3 years
Weight
Time frame: Once every year over 3 years
Body-Mass-Index
Time frame: Once every year over 3 years
Bodyfat percentage
Time frame: Once every year over 3 years
Fat mass
Time frame: Once every year over 3 years
Fat-free mass
Time frame: Once every year over 3 years
Muscle mass
Time frame: Once every year over 3 years
Water content
Time frame: Once every year over 3 years
Waist circumference
Time frame: Once every year over 3 years
Hip circumference
Time frame: Once every year over 3 years
Sitting height (cm)
Time frame: Once every year over 3 years
Erythrocytes
Time frame: Once every year over 3 years
GOT (AST)
Time frame: Once every year over 3 years
GPT (ALT)
Time frame: Once every year over 3 years
GGT
Time frame: Once every year over 3 years
Cholesterol
Time frame: Once every year over 3 years
HDL-Cholesterol
Time frame: Once every year over 3 years
Non-HDL (calc.)
Time frame: Once every year over 3 years
LDL-Cholesterol
Time frame: Once every year over 3 years
Creatinine
Time frame: Once every year over 3 years
Uric acid
Time frame: Once every year over 3 years
hsCRP
Time frame: Once every year over 3 years
fT3
Time frame: Once every year over 3 years
Glutathion peroxidase
Time frame: Once every year over 3 years
Superoxide dismutase
Time frame: Once every year over 3 years
Endothelin-1
Time frame: Once every year over 3 years
Nitric Oxide
Time frame: Once every year over 3 years
Ferritin
Time frame: Once every year over 3 years
Leptin
Time frame: Once every year over 3 years
Training intensity
Time frame: Once every year over 3 years
Hemoglobin
Time frame: Once every year over 3 years
HBE/MCH
Time frame: Once every year over 3 years
MCV
Time frame: Once every year over 3 years
Hematocrit
Time frame: Once every year over 3 years
MCHC
Time frame: Once every year over 3 years
RDW (Ery)
Time frame: Once every year over 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2024.
- Background: PubMed 31649936Baumgartner L, Schulz T, Oberhoffer R, Weberruss H. Influence of Vigorous Physical Activity on Structure and Function of the Cardiovascular System in Young Athletes-The MuCAYA-Study. Front Cardiovasc Med. 2019 Oct 9;6:148. doi: 10.3389/fcvm.2019.00148. eCollection 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thorsten Schulz, Dr. principal investigator
Technical University of Munich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Exercise, run by Technical University of Munich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 14 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tobias Engl, Dipl. Sportwiss. Univ. (+49 89 289 24598, tobias.engl@tum.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vascular stiffness (time frame: Once every year over 3 years). The study lists 22 primary outcomes in all. 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 NCT06259617, which also lists 1 linked publication.
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 14 Feb 2024.