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Dapagliflozin in Pulmonary Arterial Hypertension

NCT ID: NCT05179356

Last Updated: 2023-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2024-09-30

Brief Summary

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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

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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.

Conditions

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Pulmonary Arterial Hypertension Chronic Thromboembolic Pulmonary Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Dapagliflozin 10 mg once daily

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

Group Type ACTIVE_COMPARATOR

Dapagliflozin 10 MG [Farxiga]

Intervention Type DRUG

Dapagliflozin 10 mg given once daily for three months

Matching placebo

Placebo given once daily for three months

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching placebo

Interventions

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Dapagliflozin 10 MG [Farxiga]

Dapagliflozin 10 mg given once daily for three months

Intervention Type DRUG

Placebo

Matching placebo

Intervention Type DRUG

Eligibility Criteria

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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 PH 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mads Ersbøll

OTHER

Sponsor Role lead

Responsible Party

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Mads Ersbøll

Medical doctor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Rigshospitalet

Copenhagen, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Mads Ersbøll, MD, PhD

Role: CONTACT

Phone: +45 35453580

Email: [email protected]

Facility Contacts

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Mads Ersbøll, MD, PhD

Role: primary

Other Identifiers

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DAPAH16122021

Identifier Type: -

Identifier Source: org_study_id