Cardiorenal Effecs of Losartan in Kidney Transplant Recipients

Cardiovascular Complication Clinical Trial

— CELART  

Official title:

Cardiorenal Effecs of Losartan in Kidney Transplant Recipients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05243446
• Other study ID #: ST-4/CELART
• Status: Recruiting
• Start date: September 2015
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2022
• Source: Medical University of Gdansk
• Contact: Leszek Tylicki, professor
• Phone: 48583492505
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 740
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Complication
• Renal Transplant Failure

Intervention

Drug:
• Losartan
losartan treatment

Locations

Country	Name	City	State
Poland	Medical University	Gdansk

Sponsors (9)

Lead Sponsor	Collaborator
Medical University of Gdansk	Jagiellonian University, Medical University of Bialystok, Medical University of Silesia, Medical University of Warsaw, Nicolaus Copernicus University, Pomeranian Medical University Szczecin, Poznan Regional Hospital, Wroclaw Medical University

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of composite primary endpoint:	Cardiovascular (CV) death and Resuscitated sudden death and Non-fatal myocardial infarction (MI) and Non-fatal stroke and Unplanned hospitalization for heart failure or unstable angina and Onset of end-stage renal disease (ESRD) and Doubling of baseline serum creatinine concentration, sustained for at least one month.	Up to 5 years
Secondary	Occurrence of cardiovascular complications	Cardiovascular (CV) death and Resuscitated sudden death and Non-fatal myocardial infarction (MI) and Non-fatal stroke and Unplanned hospitalization for heart failure or unstable angina	Up to 5 years
Secondary	Occurrence of renal complications	ESRD or doubling of baseline serum creatinine	Up to 5 years
Secondary	Decline in estimated glomerular filtration rate (eGFR)	Difference in degree of eGFR reduction	Up to 5 years
Secondary	Urine albumine concentration	Difference in albuminuria in the measurements available for each patient	after 6 months
Secondary	N-acetyl-ß-D-glucosaminidase (NAG) urine excretion	Difference in urine NAF in the measurements available for each patient	after 6 months
Secondary	15-F2t-isoprostanes (isoprostanes) urine excretion	differences in 15-F2t-isoprostanes (isoprostanes) urine excretion in the measurements available for each patient	after 6 months