Assessing the effect of mirabegron to treat high blood pressure in the lungs

Phase 4

• Conditions: Pulmonary Hypertension; Right heart failure; Cardiovascular - Hypertension; Respiratory - Other respiratory disorders / diseases; Cardiovascular - Other cardiovascular diseases

• Registration Number: ACTRN12620001349932
• Lead Sponsor: Royal Prince Alfred Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-12-14
• Last Update Posted: 5 January 2021

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

We will enrol patients with a diagnosis of PH that fulfil all of the following criteria:
A- PH due to following aetiologies/diagnostic classifications:
- Group 1 pulmonary hypertension
- Chronic pulmonary hypertension due to inoperable small distal pulmonary emboli (also known as CTEPH

AND
B-The patient is:
-PH treatment naïve or,
-on an endothelin receptor antagonist (ERA) (Bosentan, Macitentan or Ambrisentan) as monotherapy, or,
-on combination therapy with an ERA (Bosentan, Macitentan or Ambrisentan) plus an agent in the NO pathway (Sildenafil, Tadalafil or Riociguat) when the NO-related therapy can be safely withheld in short-term
AND
C-The right heart catheterisation is clinically indicated.
AND
D- The participant does not meet any of the exclusion criteria

Exclusion Criteria

•Significant hepatic (transaminases or bilirubin x 3 above upper reference level) or renal impairment (GFR< 30 ml/min/1,73 m2).
•Significant hypotension (defined as symptomatic systolic blood pressure < 80 mmHg) or hypertension (defined as systolic >180 mmHg and/or diastolic blood pressure >110 mmHg).
•Right heart failure defined with PH associated with systemic venous congestion and fluid retention (e.g. peripheral oedema, ascites)
•Left heart failure (LVEF <50% and clinical signs of left heart failure).
•Severe interstitial lung disease with forced vital capacity (FVC) < 70%
•Congenital or drug-induced QT prolongation.
•Patients with known bladder outlet obstruction and patients taking antimuscarinic medications for overactive bladder syndrome.
•Anaemic patients with Hb <100 mg/dL and iron deficiency or gastrointestinal bleed within 6 months.
•Treatment with a tricyclic antidepressant or CYP2D6 substrates other than beta-blockers or treatment with digoxin.
•Pregnancy in female participants : female subjects of childbearing potential must have a pregnancy test performed with negative results known within 7 days prior to the index procedure.
•Breast feeding in female participants: female subject is not breastfeeding at the time of the screening visit and will not be breast-feeding at the time of the study.
•Subject has participated in another study during the 30 days preceding the current study.
•Hypersensitivity(allergic reaction) to inhaled nitric oxide
•Subject is part of a vulnerable population who, in the judgment of the investigator, is unable to give Informed Consent for reasons of incapacity, immaturity, adverse personal circumstances or lack of autonomy.This may include: Individuals with mental disability, persons in nursing homes, children, impoverished persons, persons in emergency situations, homeless persons, nomads, refugees, and those incapable of giving informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, members of the armed forces, and persons kept in detention.

Study & Design

• Study Type: Interventional
• Study Design: Not specified