Clinical trial NCT05243446: Cardiorenal Effecs of Losartan in Kidney Transplant Recipients
Official title: Cardiorenal Effecs of Losartan in Kidney Transplant Recipients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Renal Transplant Failure
Cardiovascular Complication
Keywords: angiotensin receptor blocker
kidney transplant recipients
albuminuria
cardiovascular disease
nephroprotection
Lead sponsor: Medical University of Gdansk
Sponsor class: OTHER
Collaborators: name: Medical University of Warsaw
name: Pomeranian Medical University Szczecin
name: Jagiellonian University
name: Medical University of Bialystok
name: Nicolaus Copernicus University
name: Medical University of Silesia
name: Poznan Regional Hospital
name: Wroclaw Medical University
First posted: 2022-02-17
Enrollment: 740
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients after renal transplantation.

Brief summary: The influence of Losartan to cardiovascular and renal outcomes in patients after renal transplatation.

Detailed description: The benefits of cardio and nephroprotective properties of treatment with drugs blocking the renin angiotensin aldosterone system in the general population has already been shown. There are no data on the cardiac and renal effects of this type of treatment in patients after renal transplantation.

Therefore, the observational, case-control study was designed in a population of kidney transplant recipients.

The study group consists of patients treated with antihypertensive drugs including Losartan at a minimum dose of 50mg.

The control group consists of patients treated with antihypertensive drugs, without the renin angiotensin aldosterone system blockade.

Blood pressure will be controlled in accordance with the current recommendations.

The primary aim of this study is to determine whether, in renal transplant recipients with hypertension, losartan, angiotensin II receptor antagonist improves cardiovascular and graft outcome i.e. reduces incidence of cardiovascular complications and slows progression of graft insufficiency. Secondary objective is to determine whether losartan 1. delays the occurrence of cardiovascular complications, 2. slows progression of graft insufficiency, 3. is the safe drug in renal transplant recipients, 4. decrease albuminuria and other surrogate markers of graft injury or cardiovascular involvement.

Eligibility criteria: Inclusion Criteria:

740 patients, either sex, either non-diabetic or diabetic who underwent the kidney transplantation and who:

1. Are at least three months post-transplantation
2. Have hypertension.
3. Have an estimated glomerular filtration rate greater than or equal to 30 ml/min/1.73 m2

Exclusion Criteria:

1. Pregnant or the possibility of becoming so and breast feeding.
2. Angioedema from an Angiotensin Converting Enzyme (ACE) inhibitor or Angiotensin Receptor Blocker (ARB) in the history.
3. Serum potassium greater than 5.5 mmol/l on two or more occasions in the preceding three months.
4. Graft artery stenosis (i.e. psv of more than 200 cm/s in doppler usg)
5. Left ventricular dysfunction that requires an ACE inhibitor or an ARB
6. New immunosuppressive agent was started or previous immunosuppressant stopped in the three months prior to study entry or plan to switch immunosuppressive agents within next three months.
7. Currently on four or more blood pressure pills and have an average blood pressure over three visits greater than 150/100.
8. Currently on an ACE-inhibitor or an ARB or treatment with an ACE inhibitor or ARB after kidney transplantation lasted more than 3 months.
9. Had an acute coronary syndrome, episode of malignant hypertension, stroke or transient ischaemic attack in the three months prior to study entry.

Primary outcomes:
measure: Occurrence of composite primary endpoint:
timeFrame: Up to 5 years
Secondary outcomes:
measure: Occurrence of cardiovascular complications
timeFrame: Up to 5 years
measure: Occurrence of renal complications
timeFrame: Up to 5 years
measure: Decline in estimated glomerular filtration rate (eGFR)
timeFrame: Up to 5 years
measure: Urine albumine concentration
timeFrame: after 6 months
measure: N-acetyl-β-D-glucosaminidase (NAG) urine excretion
timeFrame: after 6 months
measure: 15-F2t-isoprostanes (isoprostanes) urine excretion
timeFrame: after 6 months
Other outcomes:
Locations:
city: Gdansk
country: Poland
facility: Medical University
Study officials:
affiliation: Medical University of Gdansk
name: Leszek Tylicki, professor
role: PRINCIPAL_INVESTIGATOR
References: