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New treatment option for Kidney Transplant Recipients
Official title Exercise and Diet Effects in Reducing Cardiovascular Risk in Kidney Transplant Recipients
ClinicalTrials.gov ID: NCT06806670
What this study is testing
- What it's testing
- The goal of this clinical trial is to assess whether, over an observation period of 3 years, there is a reduction in cardiovascular risk, and the extent of this reduction, in a group of adult kidney transplant patients undergoing tailored exercise combined with dietary counselling compared to a group of patients following the 'standard of care'.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 30 to 69
You may be able to join if
- Clinically stabilised male and female kidney transplant patients (assessment by the referring transplant centre)
- Minimum age, 30 years;
- Maximum age, 69 years;
- Period since transplantation: from 6 months (subject to clinical stability being achieved) to 10 years;
- Organ function: eGFR (CKD-EPI formula) ≥ 30 mL/min/1.73m ;2
You likely can't join if
- Patients unable to follow the prescription,
- Recent acute cardiovascular event (\< 2 months),
- Unstable angina,
- Hyperkinetic/hypokinetic arrhythmias not controlled by therapy, and with signs of haemodynamic impairment,
- Severe aortic stenosis,
- Heart failure NYHA class III-IV, FE \< 40%,
See the full eligibility criteria
- Clinically stabilised male and female kidney transplant patients (assessment by the referring transplant centre)
- Minimum age, 30 years;
- Maximum age, 69 years;
- Period since transplantation: from 6 months (subject to clinical stability being achieved) to 10 years;
- Organ function: eGFR (CKD-EPI formula) ≥ 30 mL/min/1.73m ;2
- Obtaining informed consent;
- Patients unable to follow the prescription,
- Recent acute cardiovascular event (\< 2 months),
- Unstable angina,
- Hyperkinetic/hypokinetic arrhythmias not controlled by therapy, and with signs of haemodynamic impairment,
- Severe aortic stenosis,
- Heart failure NYHA class III-IV, FE \< 40%,
- Acute illnesses that limit physical activity,
- Severe hypertension (basal BP ≥200/110 mm Hg),
- Neuro-musculo-skeletal pathologies that may be aggravated by exercise,
- Patients unwilling to change lifestyle;
- Any form of substance abuse, psychiatric disorder or condition that, according to the investigator, can complicate communication between doctor and patient;
- Pregnant women.
The study team makes the final eligibility decision.
Where it's taking place
- Bologna, BO, Italy
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 30 years to 69 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bologna, BO, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.