RecruitingNot ApplicableNCT04972656

Treatment With Ambrisentan in Patients With Borderline Pulmonary Arterial Hypertension

Treatment With Ambrisentan in Patients With Borderline Pulmonary Arterial Hypertension: a Multicenter, Randomized, Double-blind, Placebo-controlled Study

Sponsor

Nanjing First Hospital, Nanjing Medical University

Enrollment

420 participants

Start Date

Sep 5, 2022

Study Type

INTERVENTIONAL

Conditions

Pulmonary Arterial Hypertension

Summary

An Investigator initiated trial (IIT) using a prospective, randomized, double-blind, parallel group, placebo-controlled, clinical study design.

Eligibility

Min Age: 18 Years

Inclusion Criteria3

Subject must be age ≥18 years;
Subject has mPAP 21-24 mmHg, and PAWP\<15mmHg.The underlying diseases that cause critical PAH belong to the first group, which is divided into: Idiopathic pulmonary hypertension, hereditary pulmonary hypertension, drugs and poisons associated with pulmonary hypertension, connective tissue diseases associated with pulmonary hypertension, HIV infection associated with pulmonary hypertension, portal hypertension associated with pulmonary hypertension, tumors associated with pulmonary hypertension, congenital heart disease associated with pulmonary hypertension.
Subject (or legal guardian) understands the trial design and treatment procedures and provides written informal consent before any trial-specific tests or procedures are performed.

Exclusion Criteria17

Pulmonary hypertension (PH) confirmed by right heart catheter (RHC) before enrolment, i.e. mPAP ≥25 mmHg at rest.
Ongoing or a history of \>2 weeks of continued use of therapies that are considered definitive PH treatment: endothelin receptor antagonists (ERA; e.g. bosentan, ambrisentan), phosphodiesterase type 5 inhibitors (PDE5; e.g. sildenafil, tadalafil, vardenafil), prostanoids (e.g. epoprostenol, treprostinil, iloprost, beraprost) and soluble guanylate cyclase stimulator (e.g. Riociguat). Intermittent use of PDE5 inhibitors for male erectile dysfunction is permitted.
Known intolerance to ambrisentan or one of its excipients.
Pulmonary vein occlusive disease
Pulmonary capillary hemangiomatosis
Surgical repair or interventional occlusion of congenital heart disease within 6 months prior to screening of this study
Active connective tissue diseases
Pulmonary hypertension due to left heart disease
Pulmonary hypertension due to pulmonary disease and/or hypoxia
Acute pulmonary embolism and/or chronic thromboembolism
Clinically significant anemia, defined as hemoglobin concentration 75% below the normal lower limit.
Renal insufficiency was defined as glomerular filtration rate \[EGFR\] \<30 mL/min/1.73m2.
Transaminase (ALT and/or AST) increased, exceeding the upper limit of normal value by 3 times.
Arterial systolic blood pressure \< 85 mmHg.
Uncontrolled hypertension, defined as blood pressure \>160/90 mmHg (resting state) and/or \>220/120 mmHg (load state).
Participate in any drug clinical trial within 4 weeks prior to screening in this study and/or plan to participate in another drug clinical trial during the study period.
Pregnant or lactating women.

Interventions

DRUGAmbrisentan

Titration: Monotherapy using ambrisentan will be initialized at a beginning dose of 5 mg (once daily). Drug intake is scheduled at the morning. After 4 weeks monitoring, the dose of ambrisentan will be uptitrated to 10 mg once daily. Otherwise, if intolerability is indicated, a dose of 5 mg (once daily) will be maintained through the study duration. Maximum dose allowed: not to exceed 10 mg/day. Administration: Ambrisentan will be administered orally with or without food intake.

DRUGPlacebo

Placebo tablet (one to two tablets corresponding to one to two verum tablets). Administration: Placebo will be administrated orally with or without food intake in the morning.