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CardiologyRandomized Clinical Trial5 min read

Dapagliflozin for Renal Protection in Heart Transplant Recipients: A Randomized Clinical Trial

The DAPAgliflozin for Renal protection in Heart Transplant recipients (DAPARHT) trial is a multicenter, double-blind, randomized, placebo (inactive comparison treatment)-controlled trial conducted at six heart transplant centers in Northern Europe.

Published in CirculationRandomized controlled trial
5/5 Gold Standard
Evidence Meter · 5/5

Gold-Standard Human Evidence

Backed by randomized controlled human trials or a formal meta-analysis pooling multiple clinical studies.

Source

Follow-Up Window

2 weeks

In heart transplant recipients, dapagliflozin, compared with (inactive comparison treatment), improved the slope of the from 2 weeks to 12 months of treatment.

What Changes?

Cardiology · Randomized Clinical Trial

Current Standard

Conventional cardiology practice relies on standard-of-care monitoring and existing regimens prior to this .

New Finding

Sodium-glucose cotransporter-2 () inhibitors may attenuate the decline in kidney function, but evidence in heart transplant recipients is limited.

3 Key Takeaways

Plain English Summary
  1. 01Core Finding

    We randomized adult heart transplant recipients with an estimated glomerular filtration rate () ≥25 mL/min/1.73 m ² at least one year after transplantation 1:1 to receive dapagliflozin 10 mg or matching (inactive comparison treatment) once daily.

  2. 02Study Evidence

    Tested in a (430 participants) at the randomized clinical trial stage.

  3. 03Practical Meaning

    Controlled trial findings show causal benefit under protocol rules; real-world effectiveness can vary across patients.

What This Means for You

In heart transplant recipients, dapagliflozin, compared with (inactive comparison treatment), improved the slope of the from 2 weeks to 12 months of treatment.

The Discovery

Progressive kidney disease is common in heart transplant recipients due to calcineurin inhibitor exposure and pre-existing comorbidities. Sodium-glucose cotransporter-2 () inhibitors may attenuate the decline in kidney function, but evidence in heart transplant recipients is limited.

The DAPAgliflozin for Renal protection in Heart Transplant recipients (DAPARHT) trial is a multicenter, double-blind, randomized, (inactive comparison treatment)-controlled trial conducted at six heart transplant centers in Northern Europe. We randomized adult heart transplant recipients with an estimated glomerular filtration rate () ≥25 mL/min/1.73 m ² at least one year after transplantation 1:1 to receive dapagliflozin 10 mg or matching once daily. The primary endpoint was the slope of the from 2 weeks after treatment initiation to the end of the 12-month blinded treatment period.

Between June 2022 and September 2025, we randomized 430 participants, of whom 217 were allocated to dapagliflozin and 213 were allocated to (inactive comparison treatment). We included the 424 patients with at least one measurement after baseline in the full analysis set. Their mean age was 53 ± 14 years and 29& were women. The at baseline was 67 ± 22 mL/min/1.73 m 2 . The median time from transplantation was 7 (3 - 13) years. Dapagliflozin improved the chronic slope of the compared with . The change in the from 2 weeks to 12 months after treatment initiation was 2.0 (95% confidence interval [CI] 1.0 - 3.1) mL/min/1.73 m 2 in the dapagliflozin group and 0.3 (95% CI -0.8 - 1.4) mL/min/1.73 m 2 in the group for a between-group difference of 1.7 (95% confidence interval 0.1 - 3.3) mL/min/1.73 m ² ; p = 0.03. There were no unexpected safety signals and similar rates of adverse events, including infections, between groups.

How It Works, Simply

This cardiology research focuses on cardiovascular hemodynamic & lipid pathway modulation. Researchers evaluated it using a randomized controlled trial (430 participants) at the randomized clinical trial stage of medical research.

3 Key Takeaways

Clinical Takeaways
  1. 01Core Finding

    We randomized adult heart transplant recipients with an estimated glomerular filtration rate () ≥25 mL/min/1.73 m ² at least one year after transplantation 1:1 to receive dapagliflozin 10 mg or matching once daily.

  2. 02Study Evidence

    Tested in a (430 participants) at the randomized clinical trial stage.

  3. 03Practical Meaning

    Controlled trial findings show causal benefit under protocol rules; real-world effectiveness can vary across patients.

Key Numbers

Quantitative Study Readout
12-month
Study Duration
12 months
Follow-Up Window
01

Biological Mechanism & Study Design

Study Design & Cohort

Randomized controlled trial

Randomized controlled trial (430 participants) · Randomized Clinical Trial

Biological Pathway & Modality

Cardiovascular hemodynamic & lipid pathway modulation

Intervention: Dapagliflozin for Renal Protection in Heart Transplant Recipients: A Randomized

02

Experimental Findings & Endpoints

Progressive kidney disease is common in heart transplant recipients due to calcineurin inhibitor exposure and pre-existing comorbidities.

Sodium-glucose cotransporter-2 () inhibitors may attenuate the decline in kidney function, but evidence in heart transplant recipients is limited.

The DAPAgliflozin for Renal protection in Heart Transplant recipients (DAPARHT) trial is a multicenter, double-blind, randomized, -controlled trial conducted at six heart transplant centers in Northern Europe. We randomized adult heart transplant recipients with an estimated glomerular filtration rate () ≥25 mL/min/1.73 m ² at least one year after transplantation 1:1 to receive dapagliflozin 10 mg or matching once daily.

The primary endpoint was the slope of the from 2 weeks after treatment initiation to the end of the 12-month blinded treatment period.

Between June 2022 and September 2025, we randomized 430 participants, of whom 217 were allocated to dapagliflozin and 213 were allocated to . We included the 424 patients with at least one measurement after baseline in the full analysis set.

Their mean age was 53 ± 14 years and 29& were women. The at baseline was 67 ± 22 mL/min/1.73 m 2 .

The median time from transplantation was 7 (3 - 13) years. Dapagliflozin improved the chronic slope of the compared with .

The change in the from 2 weeks to 12 months after treatment initiation was 2.0 (95% confidence interval [CI] 1.0 - 3.1) mL/min/1.73 m 2 in the dapagliflozin group and 0.3 (95% CI -0.8 - 1.4) mL/min/1.73 m 2 in the group for a between-group difference of 1.7 (95% confidence interval 0.1 - 3.3) mL/min/1.73 m ² ; p = 0.03. There were no unexpected safety signals and similar rates of adverse events, including infections, between groups.

03

Clinical Translation & Practice Context

In heart transplant recipients, dapagliflozin, compared with , improved the slope of the from 2 weeks to 12 months of treatment.

03

The Bottom Line · Clinical Pearl

“In heart transplant recipients, dapagliflozin, compared with placebo, improved the slope of the eGFR from 2 weeks to 12 months of treatment.”

Published in Circulation · Current Stage: Randomized Clinical Trial

Cardiology · Randomized Clinical Trial
Study Type
Randomized controlled trial

Randomized controlled trial (430 participants)

Evidence Score
5/5 · Gold-Standard Human Evidence
Evidence Meter · 5/5

Gold-Standard Human Evidence

Backed by randomized controlled human trials or a formal meta-analysis pooling multiple clinical studies.

Backed by randomized controlled human trials or a formal meta-analysis pooling multiple clinical studies.

Who It Applies To
Patients with at least one eGFR measurement after baseline in the full a
Intervention & Mechanism
Dapagliflozin for Renal Protection in Heart Transplant Recipients: A Randomized

Cardiovascular hemodynamic & lipid pathway modulation

Key Limitation
Controlled trial findings show causal benefit under protocol rules; real-world effectiveness can vary across patients.

Translational Stage

LEVEL 1 · Randomized Clinical Trial

Classified as Randomized controlled trial along the clinical evidence continuum

  1. Lab & Discovery
  2. Early Trials
  3. 3Randomized Clinical TrialActive
  4. 4Meta & Practice

Indexed Clinical Entities

Original Publication & AMA Citation

Dapagliflozin for Renal Protection in Heart Transplant Recipients: A Randomized Clinical Trial. Circulation. Published 2026;Nov 8. Accessed November 15, 2026. https://pubmed.ncbi.nlm.nih.gov/42999953/

Circulation

https://pubmed.ncbi.nlm.nih.gov/42999953/

Read Original Paper

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