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Trial record 1 of 2 for:    dapagliflozin | heart transplant
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DAPAgliflozin for Renal Protection in Heart Transplant Recipients (DAPARHT)

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ClinicalTrials.gov Identifier: NCT05321706
Recruitment Status : Recruiting
First Posted : April 11, 2022
Last Update Posted : September 7, 2022
Sponsor:
Collaborators:
Erasmus Medical Center
Skane University Hospital
Aarhus University Hospital
Karolinska University Hospital
Sahlgrenska University Hospital, Sweden
Information provided by (Responsible Party):
Lars Gullestad, Oslo University Hospital

Brief Summary:
Kidney failure is common in heart transplant recipients and is a major cause of morbidity and mortality. Sodium-glucose transporter 2 (SGLT2) inhibitors were developed as antidiabetics but were subsequently shown to reduce the incidence of adverse cardiovascular outcomes and protect renal function in non-diabetics as well as diabetics. However, SGLT2 inhibitors have not been tested in clinical trials in heart transplant recipients. The DAPARHT trial is designed to assess the effect of the SGLT2 inhibitor dapagliflozin to prevent deteriorating renal function in heart transplant recipients. Secondary objectives are to assess the impact of treatment on i) weight, ii) glucose homeostasis, iii) proteinuria, iv) the number of rejections, and (v) safety and tolerability. As exploratory outcomes, the investigators will assess the effect of treatment on renal outcomes, clinical events (death, myocardial infarction, cerebral stroke, cancer, and end-stage renal disease), cardiac function, quality of life, and new-onset diabetes.

Condition or disease Intervention/treatment Phase
Heart Transplant Failure Kidney Failure Drug: Dapagliflozin 10 mg Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 430 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The DAPARHT trial is a randomised, controlled, double blind, parallel group trial with an open-label extension phase. The primary endpoint is the slope of the eGFR measured from 2 weeks after randomisation and start of treatment to 12 months after start of treatment. The trial subjects immediately continue into the open-label phase. In this phase, patients assigned to dapagliflozin continue treatment for another 24 months. The primary endpoint of the open-label extension is the baseline-adjusted eGFR measured one month after the end of treatment, 37 months after randomisation.
Masking: Double (Participant, Care Provider)
Masking Description: One year's blinded treatment + two years' open-label extension. The primary endpoint of the blinded phase of the trial is the difference in the slope from 2 weeks to 12 months in the eGFR. The major endpoint of the open-label phase is the baseline-adjusted eGFR measured 1 months after the end of treatment.
Primary Purpose: Treatment
Official Title: DAPARHT: DAPAgliflozin for Renal Protection in Heart Transplant Recipients
Actual Study Start Date : June 8, 2022
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : June 30, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Dapagliflozin
Participants will be randomized in a 1:1 fashion to receive 10 mg of oral dapagliflozin (tablet) once daily for one year.
Drug: Dapagliflozin 10 mg
Participants will be randomized in a 1:1 fashion to receive 10 mg of oral dapagliflozin
Other Name: Farxiga

Placebo Comparator: Placebo
Participants will be randomized in a 1:1 fashion to receive a matching tablet once daily for one year.
Drug: Placebo
Participants will be randomized in a 1:1 fashion to receive a matching placebo once daily for one year.




Primary Outcome Measures :
  1. The chronic slope of the eGFR [ Time Frame: From 2 weeks to end-of-treatment (12 months) ]
    The primary endpoint will be the slope of the eGFR from 2 weeks to end-of-treatment (12 months), calculated as the difference in eGFR from two weeks to 12 months after start of the intervention.


Secondary Outcome Measures :
  1. Body weight [ Time Frame: From 2 weeks to end-of-treatment (12 months) ]
    Change in body weight 2. The change in the albumin / creatinine ratio in the urine from baseline to end-of-treatment in patients with a baseline ratio > 30 mg/g at baseline 3. The change in the blood level of glycated haemoglobin (HbA1c) in patients with diabetes mellitus

  2. Glycosylated hemoglobin (HbA1c) [ Time Frame: From 2 weeks to end-of-treatment (12 months) ]
    Change in the blood level of HbA1c in patient with diabetes mellitus

  3. Proteinuria [ Time Frame: From 2 weeks to end-of-treatment (12 months) ]
    Change in the albumin / creatinine ratio in the urine in patients with a baseline ratio > 30 mg/g



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Heart transplant recipient ≥ 1 year after heart transplant.
  2. Age ≥ 18 years

Exclusion Criteria:

  1. Contraindications to study medication.
  2. Estimated GFR < 25 ml/min/m2
  3. Type I diabetes
  4. Severe liver failure (Child-Pugh's score C)
  5. Life expectancy reduced to < 2 years as judged by the investigator
  6. Unresolved malignant disease
  7. Failure to obtain written informed consent
  8. SGL2 inhibitor treatment over the last month
  9. Pregnancy
  10. Breast-feeding
  11. Woman of child-bearing potential who is not willing to use a highly effective method of birth control

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05321706


Contacts
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Contact: Kaspar Broch, MD, PhD +4792091824 sbbrok@ous-hf.no
Contact: Lars Gullestad, MD, PhD +4797644772 lars.gullestad@medisin.uio.no

Locations
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Denmark
Aarhus University Hospital Not yet recruiting
Skejby, Denmark, 8200
Contact: Hans Eiskjær, MD, PhD       hanseisk@rm.dk   
Netherlands
Erasmus Medical Center Not yet recruiting
Rotterdam, Netherlands
Contact: Olivier Manintveld, MD, PhD    +31 10 703 50 78    o.manintveld@erasmusmc.nl   
Norway
Oslo University Hospital, Rikshospitalet Recruiting
Oslo, Norway, 0372
Contact: Lars Gullestad, MD, PhD    0047 23070000    lars.gullestad@medisin.uio.no   
Contact: Kaspar Broch, MD, PhD    0047 92091824    sbbrok@ous-hf.no   
Sweden
Sahlgrenska University Hospital Not yet recruiting
Gothenburg, Sweden, SE-41345
Contact: Niklas Bergh, MD, PhD       niklas.bergh@vgregion.se   
Skane University Hospital Not yet recruiting
Lund, Sweden, 22185
Contact: Oscar Braun, MD, PhD       oscar.braun@med.lu.se   
Karolinska University Hospital Not yet recruiting
Stockholm, Sweden
Contact: Ida H Löfman, PhD       ida.haugen-lofman@regionstockholm.se   
Sponsors and Collaborators
Oslo University Hospital
Erasmus Medical Center
Skane University Hospital
Aarhus University Hospital
Karolinska University Hospital
Sahlgrenska University Hospital, Sweden
Investigators
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Principal Investigator: Olivier Manintveld, MD, PhD Erasmus Medical Center
Principal Investigator: Oscar Braun, MD, PhD Skane University Hospital
Principal Investigator: Niklas Bergh, MD, PhD Sahlgrenska University Hospital, Sweden
Principal Investigator: Hans Eiskjær, MD, PhD Aarhus University Hospital
Principal Investigator: Ida H Löfman, PhD Karolinska University Hospital
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Responsible Party: Lars Gullestad, Professor, MD, PhD, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT05321706    
Other Study ID Numbers: 2021-003175-34
First Posted: April 11, 2022    Key Record Dates
Last Update Posted: September 7, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Lars Gullestad, Oslo University Hospital:
Renal protection
Heart transplant
Dapagliflozin
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Diseases
Urologic Diseases
Dapagliflozin
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs