Prevention of Akute Kidney Injury, Hearttransplant, ANP

Prevention of Akute Kidney Injury With Human Atrial Natriuretic Peptide in Patients Undergoing Heart Transplant.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02665377

Enrollment

Registered

2016-01-27

Start date

2016-09-25

Completion date

2022-01-08

Last updated

2022-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Injury

Brief summary

Prospective, blinded, placebo-controlled trial. Patients: Adult patients (\>18 years of age) undergoing de novo Htx, with a preoperative GFR \> 30ml/min, not receiving an ABO-incompatible organ with an ischemia time of \> 6 hours. A donor age \> 70 years is an exclusion criteria. Intervention: Infusion of h-ANP fore five days, starting at the induction of anesthesia. Outcome: Kidney function, evaluated with serum creatinine day 1-7 and kidney clearance, 4-5 Days after Htx plus after 3 and 12 months.

Interventions

DRUGANP

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* De novo Htx. * Preoperative GFR \> 30ml/min/1,73m2. * \>18 years old. * Written consent.

Exclusion criteria

* Multi organ transplantation or previous heart transplant. * ECMO * Donor age \> 70 years. * Dialysis. * ABO-incompatible organ. * Donor heart ischemia time \> 6 tim. * Known kidney disease. * Other planed study within 2 mounth.

Design outcomes

Primary

Measure	Time frame
GFR 4-5 days after Htx	4-5 days

Secondary

Measure	Time frame
GFR 1 year after Htx	1 year

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026