Cardiorenal Effecs of Losartan in Kidney Transplant Recipients

NCT05243446 | Unknown DMC

• 1 other identifier: ST-4/CELART
• Study Type: observational
• Target: 740
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Renal Transplant Failure; Cardiovascular Complication

Keywords

angiotensin receptor blocker; kidney transplant recipients; albuminuria; cardiovascular disease; nephroprotection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Occurrence of cardiovascular complications

  Up to 5 years

• Occurrence of renal complications

  Up to 5 years

• Decline in estimated glomerular filtration rate (eGFR)

  Up to 5 years

• Urine albumine concentration

  after 6 months

• N-acetyl-β-D-glucosaminidase (NAG) urine excretion

  after 6 months

Study Arms (2)

Study group

Hypotensive treatment including Losartan

Drug: Losartan

Control group

Hypotensive treatment without renin-angiotensin-aldosteron system blockers.

Interventions

Losartan DRUG

losartan treatment

Also known as: Lozap, Lorista, Xartan, Losacor

Study group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients after renal transplantation.

You may qualify if:

• patients, either sex, either non-diabetic or diabetic who underwent the kidney transplantation and who:
• Are at least three months post-transplantation
• Have hypertension.
• Have an estimated glomerular filtration rate greater than or equal to 30 ml/min/1.73 m2

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of Gdansk: lead
• Medical University of Warsaw: collaborator
• Pomeranian Medical University Szczecin: collaborator
• Jagiellonian University: collaborator
• Medical University of Bialystok: collaborator
• Nicolaus Copernicus University: collaborator
• Medical University of Silesia: collaborator
• Poznan Regional Hospital: collaborator
• Wroclaw Medical University: collaborator

Study Sites (1)

Medical University

Gdansk, 80-952, Poland

RECRUITING

MeSH Terms

Conditions

Albuminuria; Cardiovascular Diseases

Interventions

Losartan

Condition Hierarchy (Ancestors)

Proteinuria; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrazoles

Study Officials

• Leszek Tylicki, professor

  Medical University of Gdansk

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leszek Tylicki, professor

CONTACT

48583492505

Zbigniew Heleniak

CONTACT

48583492505; zth1@gumed.edu.pl

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 24, 2022
• First Posted: February 17, 2022
• Study Start: September 1, 2015
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2023
• Last Updated: February 17, 2022

Record last verified: 2022-02

Locations

PL (1)