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Dapagliflozin in Pulmonary Arterial Hypertension (DAPAH)

Primary Purpose

Pulmonary Arterial Hypertension, Chronic Thromboembolic Pulmonary Hypertension

Status

Recruiting

Phase

Phase 2

Locations

Denmark

Study Type

Interventional

Intervention

Dapagliflozin 10 MG [Farxiga]

Placebo

About this trial

This is an interventional treatment trial for Pulmonary Arterial Hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

A diagnosis of PAH group 4 or group 1 in any of the following subtypes:
- Idiopathic PAH (iPAH)
- Heritable PAH (hPAH)
- Connective tissue disease associated PAH (aPAH)
- In case of PAH in group 4, no further invasive treatment including pulmonary endarterectomy or pulmonary balloon angioplasty must be planned at time of inclusion.
Symptomatic PAH in WHO functional class II-III as assessed by the screening clinician.
Clinically stable patients on pulmonary vasodilator treatment with PDE5i, ERA, PA/IPA alone or in combination without considerations from the treating physician team towards treatment escalation and a treatment duration of at least four weeks. Clinical stability defined as stable symptoms without progression as assessed by treating clinician and without the need for unplanned hospital admissions due to worsening PAH within three months of screening.
Fertile women (< 50 years of age) must use safe contraceptives (Intra uterine device or hormonal contraception) for the duration of the study and have a negative pregnancy test
Able to understand the written patient information in Danish and give informed consent.
Age ≥ 18 years
Ability to perform cardio pulmonary exercise test

Exclusion Criteria:

Known allergy to the study medication
Treatment with an SGLT2i within 6 months prior to baseline
Type 1 or type 2 diabetes
Impaired renal function with an eGFR < 30 mL/min/m2 within four weeks of screening
Severe liver dysfunction (Child-Pugh class c)
Listed for lung transplantation at the time of screening
Planned initiation of iv prostacyclin therapy/ IPA or current dose escalation planned
Planned pulmonary endarterectomy or pulmonary balloon angioplasty.
LVEF < 50%
Diagnosis of PAH group 2, 3 or 5

Sites / Locations

RigshospitaletRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Dapagliflozin 10 mg once daily

Matching placebo

Arm Description

Dapagliflozin 10 mg (Farxiga 10 mg) given once daily for three months

Placebo given once daily for three months

Outcomes

Primary Outcome Measures

Change in VO2 max from baseline to follow up

Secondary Outcome Measures

Change in 6 minutes walking distance

Change in VE/VCO2

Change in pulmonary vascular resistance

Change in mean pulmonary artery pressure

Change in Cardiac index

Change in central venous pressure

Change in transpulmonary gradient

Change in pulmonary arterial compliance

Change in right ventricular size on 3D echocardiography

Change in right ventricular free wall strain

Change in right ventricular free wall strain-work (free wall strain/ pulmonary artery pressure)

Change in NTproBNP

Change in EQ-5D-5L questionnaire

Change in metabolomic pattern on central venous blood

Full Information

NCT ID

NCT05179356

First Posted

December 16, 2021

Last Updated

August 11, 2023

Sponsor

Mads Ersbøll

1. Study Identification

Unique Protocol Identification Number

NCT05179356

Brief Title

Dapagliflozin in Pulmonary Arterial Hypertension

Acronym

DAPAH

Official Title

Effects of DAPAgliflozin on Cardiopulmonary Exercise Capacity and Hemodynamics in Pulmonary Arterial Hypertension: A Double Blind Randomized Trial. (DAPAH-trial)

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 1, 2023 (Actual)

Primary Completion Date

June 2024 (Anticipated)

Study Completion Date

September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Mads Ersbøll

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to investigate the effects of dapagliflozin on exercise capacity and hemodynamics in patients with pulmonary arterial hypertension

Detailed Description

The objective of this study is to evaluate the effects of oral dapagliflozin (Forxiga®) treatment versus placebo in clinically stable patients with pulmonary arterial hypertension or CTEPH on background vasodilator combination therapy on cardio-pulmonary exercise capacity, pulmonary vascular hemodynamics, RV function and metabolomic profile of the pulmonary vascular endothelium.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pulmonary Arterial Hypertension, Chronic Thromboembolic Pulmonary Hypertension

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Dapagliflozin 10 mg once daily

Arm Type

Active Comparator

Arm Description

Dapagliflozin 10 mg (Farxiga 10 mg) given once daily for three months

Arm Title

Matching placebo

Arm Type

Placebo Comparator

Arm Description

Placebo given once daily for three months

Intervention Type

Drug

Intervention Name(s)

Dapagliflozin 10 MG [Farxiga]

Intervention Description

Dapagliflozin 10 mg given once daily for three months

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Matching placebo

Primary Outcome Measure Information:

Title

Change in VO2 max from baseline to follow up

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Change in 6 minutes walking distance

Time Frame

3 months

Title

Change in VE/VCO2

Time Frame

3 months

Title

Change in pulmonary vascular resistance

Time Frame

3 months

Title

Change in mean pulmonary artery pressure

Time Frame

3 months

Title

Change in Cardiac index

Time Frame

3 months

Title

Change in central venous pressure

Time Frame

3 months

Title

Change in transpulmonary gradient

Time Frame

3 months

Title

Change in pulmonary arterial compliance

Time Frame

3 months

Title

Change in right ventricular size on 3D echocardiography

Time Frame

3 months

Title

Change in right ventricular free wall strain

Time Frame

3 months

Title

Change in right ventricular free wall strain-work (free wall strain/ pulmonary artery pressure)

Time Frame

3 months

Title

Change in NTproBNP

Time Frame

3 months

Title

Change in EQ-5D-5L questionnaire

Time Frame

3 months

Title

Change in metabolomic pattern on central venous blood

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: A diagnosis of PAH group 4 or group 1 in any of the following subtypes: Idiopathic PAH (iPAH) Heritable PAH (hPAH) Connective tissue disease associated PAH (aPAH) Associated with congenital heart disease (aPAH) In case of PAH in group 4, no further invasive treatment including pulmonary endarterectomy or pulmonary balloon angioplasty must be planned at time of inclusion. Symptomatic PAH in WHO functional class II-III as assessed by the screening clinician. Clinically stable patients on pulmonary vasodilator treatment with PDE5i, ERA, PA/IPA alone or in combination without considerations from the treating physician team towards treatment escalation and a treatment duration of at least four weeks. Clinical stability defined as stable symptoms without progression as assessed by treating clinician and without the need for unplanned hospital admissions due to worsening PAH within three months of screening. Fertile women (< 50 years of age) must use safe contraceptives (Intra uterine device or hormonal contraception) for the duration of the study and have a negative pregnancy test Able to understand the written patient information in Danish and give informed consent. Age ≥ 18 years Ability to perform cardio pulmonary exercise test Exclusion Criteria: Known allergy to the study medication Treatment with an SGLT2i within 6 months prior to baseline Type 1 or type 2 diabetes Impaired renal function with an eGFR < 30 mL/min/m2 within four weeks of screening Severe liver dysfunction (Child-Pugh class c) Listed for lung transplantation at the time of screening Planned initiation of iv prostacyclin therapy/ IPA or current dose escalation planned Planned pulmonary endarterectomy or pulmonary balloon angioplasty. LVEF < 50% Diagnosis of PAH group 2, 3 or 5

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mads Ersbøll, MD, PhD

Phone

+45 35453580

mads.kristian.ersboell.02@regionh.dk

Facility Information:

Facility Name

Rigshospitalet

City

Copenhagen

ZIP/Postal Code

2100

Country

Denmark

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mads Ersbøll, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD

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Dapagliflozin in Pulmonary Arterial Hypertension

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