Dapagliflozin in Pulmonary Arterial Hypertension

Launched by MADS ERSBØLL · Dec 16, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a medication called dapagliflozin to see how it affects the ability to exercise and blood flow in patients with pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension. The goal is to understand if this medication can help improve the quality of life for those with these conditions.

To participate in the trial, individuals must be at least 18 years old and have been diagnosed with certain types of PAH. They should be experiencing symptoms that fall into specific categories, and their condition must be stable, meaning they haven’t needed to go to the hospital for worsening symptoms in the last three months. Participants will be required to perform a specific exercise test and must be able to understand the study information in Danish. If eligible, participants can expect regular check-ups and monitoring throughout the study to assess the effects of the medication. It's important to note that certain health conditions, such as diabetes or severe liver problems, may prevent someone from joining the trial.

Gender

ALL

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 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