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92 active trials for Pulmonary Hypertension

Investigation of Dysynchrony in Patients With Pulmonary Hypertension

The purpose of the study is to determine whether patients with pulmonary hypertension (PH) have dysynchrony, and if so whether it is electrical or mechanical. Once this has been determined, during a catheterization the investigators will test if pacing the heart improves blood circulation.

Start: September 2006

Chlorhexidine Mouthwash and Oral Nitrate in Adults With Pulmonary Hypertension

This is an open-label, single-center study to examine distinguishing features of the structure and function of the oral and gut microbiome in volunteers with PH in the breakdown of oral nitrate and effect on hemodynamics.

Start: December 2021

A Study Evaluating the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in PAH Patients

Study ROR-PH-301, ADVANCE OUTCOMES, is designed to assess the efficacy and safety of ralinepag when added to pulmonary arterial hypertension (PAH) standard of care or PAH-specific background therapy in subjects with World Health Organization (WHO) Group 1 PAH.

Start: August 2018

A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label Extension

Study ROR-PH-303, ADVANCE EXTENSION, is an open-label extension (OLE) study for participants with WHO Group 1 PAH who have participated in another Phase 2 or Phase 3 study of ralinepag.

Start: September 2019

A Study of Ralinepag to Evaluate Effects on Exercise Capacity by CPET in Subjects With WHO Group 1 PH

Study ROR-PH-302, ADVANCE CAPACITY, is designed to evaluate the effects of ralinepag therapy on exercise capacity as assessed by change in peak oxygen consumption (VO2) derived from cardiopulmonary exercise testing (CPET) after 28 weeks of treatment

Start: October 2020

Pulmonary Hypertension Biorepository and Registry

Establish a pulmonary hypertension registry and biorepository to lead towards a further understanding of the disease.

Start: August 2020

A Phase 3 Adaptive Study to Evaluate the Safety and Efficacy of Inhaled Treprostinil in Participants With Pulmonary Hypertension (PH) Due to Chronic Obstructive Pulmonary Disease (COPD)

The primary objective of this study is to demonstrate the efficacy of inhaled treprostinil compared to placebo in improving exercise ability as measured by change from baseline in 6-Minute Walk Distance (6MWD) following 12 weeks of active treatment in participants with PH-COPD.

Start: June 2018

MK-5475 in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD) (MK-5475-006)

The main purpose of this study is to assess MK-5475 in the PH-COPD population by evaluating the safety, pharmacokinetics (PK), changes in pulmonary vascular resistance (PVR), and changes in pulmonary blood volume (PBV) after administration. The primary study hypothesis is that the MK-5475 results in superior reduction of the mean PVH following 28 days of dosing compared to placebo in participants with PH-COPD.

Start: June 2020

Physiological-based Cord Clamping in Congenital Diaphragmatic Hernia

Pulmonary hypertension is a major determinant of postnatal survival in infants with a congenital diaphragmatic hernia (CDH). The current care during the perinatal stabilisation period in infants born with this rare birth defect might contribute to the development of pulmonary hypertension after birth - in particular umbilical cord clamping before lung aeration. An ovine model of diaphragmatic hernia demonstrated that cord clamping after lung aeration, called physiological-based cord clamping (PBCC), avoided the initial high pressures in the lung vasculature while maintaining adequate blood flow, thereby avoiding vascular remodelling and aggravation of pulmonary hypertension. The investigators aim to investigate if the implementation of PBCC in the perinatal stabilisation period of infants born with a CDH could reduce the incidence of pulmonary hypertension in the first 24 hours after birth. The investigators will perform a multicentre, randomised controlled trial in infants with an isolated CDH. Before birth, infants will be randomised to either PBCC or immediate cord clamping, stratified by treatment centre and severity of pulmonary hypoplasia on antenatal ultrasound. For performing PBCC a purpose-designed resuscitation module (the Concord Birth Trolley) will be used.

Start: May 2020

A First-in-human Study to Assess the Safety and Tolerability of PDNO

This is a first-in-human (FIH), single-blind, placebo-controlled, single-centre study designed to assess the safety and tolerability of PDNO in healthy male and female subjects. In addition, the exposure of 1,2 propanediol (PD) will be evaluated. The study will be conducted in 2 parts: Part I: single ascending dose (SAD), 7 cohorts, 30 minutes intravenous (iv) infusion of placebo followed by 1 hour iv infusion of PDNO to assess safety, tolerability and PD exposure in healthy male and female subjects. Part II: ascending doses of PDNO in 2 cohorts, 30 minutes iv infusion of placebo followed by 3 ascending doses of PDNO in cohort 1 and 3 ascending doses of PDNO in cohort 2. The first 2 doses in each cohort will be iv infused for 30 minutes whereas the last will be iv infused for 3 hours to assess safety, tolerability and PD exposure in healthy male and female subjects. If indicated by emerging data and recommended by the internal safety review committee (iSRC), 2 additional dose groups/cohorts (4+4 subjects) may be added to Part I and 1 dose group/cohort (4 subjects) may be added to Part II.

Start: February 2021

Natural History Study of Biomarkers in Pulmonary Arterial Hypertension

Background: - High blood pressure in the lungs, known as pulmonary arterial hypertension (PAH), is a rare disorder. Some people have disease-associated PAH and some have PAH from an unknown cause. Researchers want to follow the natural history of all PAH patients to understand how PAH progresses in order to discover targets for future research into new treatments. To further identify treatment targets, they will compare healthy volunteers to patients with PAH. Objectives: - To study the natural history of PAH. Eligibility: Individuals at least 18 years of age who have PAH. Healthy volunteers at least 18 years of age. Design: Participants with PAH will have periodic visits to the National Institutes of Health Clinical Center. After the first visit, they will return in 6 months and then yearly or every other year for as long as the study continues. The first visit will take up to 3 days. It will involve the following tests: Physical exam and medical history Blood and urine samples Heart and lung function tests and imaging studies Six-minute walk test Questions about exercise and physical activity Healthy volunteers will have only one visit to the Clinical Center, during which they will undergo screening tests, and complete many of the same tests as patients with PAH

Start: July 2013

Remote Exercise Program Delivery Using a Mobile Application for Pulmonary Arterial Hypertension

This study will determine the feasibility of a mobile application-based home exercise rehabilitation program for patients with pulmonary hypertension.

Start: June 2021

A Study to Assess Pulsed Inhaled Nitric Oxide in Subjects With Pulmonary Fibrosis at Risk for Pulmonary Hypertension

A randomized, double-blind, placebo-controlled dose escalation and verification study to assess the safety and efficacy of pulsed inhaled nitric oxide (iNO) versus placebo in subjects at risk for pulmonary hypertension associated with pulmonary fibrosis on long term oxygen therapy. (REBUILD)

Start: December 2017

Early Diagnosis of Pulmonary Hypertension in Patients With Inflammatory Rheumatic Connective Tissue Diseases

The purposes of this study are (I), to evaluate various screening methods for their ability to predict and to confirm Pulmonary Hypertension (PH) in scleroderma patients, and (II) to evaluate the incidence of PH (i.e. the number of new cases per year) in scleroderma patients.

Start: January 2010

Inhaled Nitric Oxide for Pulmonary Hypertension and Bronchopulmonary Dysplasia

Inhaled nitric oxide (iNO) is an effective treatment for pulmonary hypertension (PH) in term and near-term infants. Preterm infants are at risk for early PH that is associated with high risk for bronchopulmonary dysplasia or death. In multiple clinical trials, iNO treatment was not effective for BPD prevention. However, infants were not screened for PH and iNO treatment was not targeted for PH. iNO treatment for PH in preterm infants is controversial due to lack of evidence. The study team hypothesizes that early diagnosis of PH (72-96 hours of life) and iNO treatment will decrease the incidence of death and bronchopulmonary dysplasia and improve oxygenation in extremely preterm infants. To determine if iNO treatment of extremely preterm infants with early pulmonary hypertension as established with echocardiographic evidence at 72-96 hours of age will decrease incidence of death or BPD. To determine if iNO treatment of extremely preterm infants with early PH will decrease the pulmonary artery pressure and improve oxygenation within 72 hours of intervention.

Start: July 2019

A Dose Escalation Study to Assess the Safety and Efficacy of Pulsed Inhaled Nitric Oxide in Subjects With Pulmonary Fibrosis or Sarcoidosis

A phase 2b, open label study to assess the safety and efficacy of increasing doses of pulsed, inhaled nitric oxide (iNO) in subjects with pulmonary fibrosis and sarcoidosis on long term oxygen therapy followed by a long term extension study

Start: January 2019

Genetic and Environmental Determinants That Control Metabolism in Pulmonary Hypertension

The investigators are performing this research study to determine whether having low iron-sulfur cluster levels can cause a disease known as pulmonary hypertension (PH). PH is defined as abnormally high blood pressure in the arteries of the lungs. Usually, small specialized structures inside each human cell called mitochondria are in charge of generating energy within lung arteries for normal function. During situations of disease or stress, lung arteries undergo a change in the function of mitochondria, resulting in the development of PH. In studies on mice, investigators have learned that alterations in the production of specific metal complexes called iron-sulfur clusters are responsible for these changes. This makes it more likely that mice will develop PH. In this study, the investigators want to find out if alteration of iron-sulfur cluster formation leads to increased likelihood of developing PH in humans.

Start: October 2015

Medication Reconciliation in Pulmonary Hypertension

Pulmonary hypertension (PH) is a life threatening condition. In PH, pulmonary arterial hypertension (PAH) and chronic thrombo-embolic chronic pulmonary hypertension (CTEPH) are two rare diseases requiring specific and complex drug management. In France ,a part of these treatments ,only available in hospital pharmacies, are generally unknown from community health care professionals despite the high risk of drug-interactions and side effects. Anticipating medication errors at the begging of the disease is therefore important, and could be done through medication reconciliation.

Start: February 2021

Effect of Exercise and Respiratory Therapy on Right Ventricular Function in Severe Pulmonary Hypertension

Chronic pulmonary hypertension (PH) is associated with impaired exercise capacity, quality of life and right ventricular function.The disease is characterized by an increase of pulmonary vascular resistance and pulmonary arterial pressure, leading to right heart insufficiency. In later stages of the disease, the right heart is not able to further increase right ventricular contractility (cardiac index) during exercise. Within the last decade, new disease-targeted medical therapies have been approved for treatment of pulmonary arterial hypertension (PAH). Sequential and upfront combinations of these agents have shown to further improve symptoms, 6-minute walking distance (6-MWD) and hemodynamics in PAH patients. Previous training studies have suggested that exercise training as add-on to medical treatment is highly effective improving exercise capacity, quality of life and symptoms. Prospective studies with a 24±12 months follow-up period suggested that exercise training may also improve the rate of clinical worsening events as the need for hospitalization, additional PH-medication, lung-transplantation and death. There is also first data that exercise training may have a positive impact on the right ventricular function. This randomised controlled study aims to assess whether exercise training

Start: August 2015

Training Single Arm

The pulmonary hypertension is a disease, which tends to a progredient right heart failure. Although there was a large progress in development of medical therapy, the quality of life, the physical efficiency and the prognosis of the patients are still limited. The aim of the study is to examine the influence of physical training to clinical and molecular parameter.

Start: November 2015