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Pulmonary Hypertension clinical trials

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NCT ID: NCT05186987 Completed - Clinical trials for Pulmonary Hypertension

Visa-versa! Breaking Instead of Pushing the Pedals-A

Start date: February 15, 2022
Phase: N/A
Study type: Interventional

Eccentric muscle work is defined as lengthening of a muscle while applying force. It was shown that with eccentric work, muscles are able to perform four times as much power compared to usual concentric work, which results in huge training gain with a highly decreased oxygen demand and thus lower cardiovascular load. Pulmonary hypertension (PH) is a chronic condition associated with significant reduced exercise capacity and increased morbidity and mortality, resulting in reduced quality of life. Physical training has been shown to be beneficial in PH, even in severely limited patients. However, due to cardiopulmonary constraints in PH, training intensities may be very low, so that many patients are physically almost unable to perform exercise on a high enough level to maintain muscle mass. A low body muscle not only feeds the vicious cycle of decreasing exercise capacity, but also has many deleterious metabolic and immunological consequences which further increase disability and decrease quality of life in PH. Thus, eccentric training, which allows to gain muscle mass with a low stress to the cardiopulmonary unit may to be highly beneficial for patients with PH and allied cardiopulmonary disease, such as chronic obstructive pulmonary disease (COPD) and heart failure. Therefore, the objective of the trial is, to compare differences in oxygen uptake (peak VO2 [l/min]) and other physiological measures during similar cardiopulmonary exercise test protocols of eccentric- vs. concentric cycling in PH- patients and comparators with or without other cardiopulmonary diseases.

NCT ID: NCT05176951 Completed - Clinical trials for Pulmonary Hypertension

A Study to Evaluate the Safety and Tolerability of Treprostinil Palmitil Inhalation Powder in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease

Start date: December 22, 2022
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to evaluate the safety and tolerability of treprostinil palmitil inhalation powder (TPIP) compared with placebo

NCT ID: NCT05128929 Completed - Clinical trials for Pulmonary Hypertension

Investigation of H01 in Adults With Pulmonary Hypertension Including Interstitial Lung Disease (The SATURN Study).

SATURN
Start date: April 1, 2022
Phase: Phase 2
Study type: Interventional

This study is a prospective, randomized, double-blind, study of H01 (Hymecromone) in adults with pulmonary hypertension (PH). The primary objective of this study is to evaluate the safety and tolerability of oral H01 and the potential benefit of oral H01 on clinical measures of PH disease severity over 24 weeks. Study Hypothesis: Oral H01, at doses of 1600 mg per day, will be a safe and well-tolerated agent in adults with pulmonary hypertension over 24 weeks

NCT ID: NCT05103189 Completed - Clinical trials for Pulmonary Hypertension

4D-flow Cardiac MRI to Assess Pulmonary Arterial Pressure in Pulmonary Hypertension

HTPFLUW
Start date: October 21, 2021
Phase: N/A
Study type: Interventional

Due to radiation exposure and low but real risk of morbidity and mortality associated with right heart catheterization, non-invasive procedures to estimate mPAP are desired for the diagnosis of PH or to monitor treatment effectiveness. Echocardiography is used as a screening tool to estimate systolic pulmonary arterial pressure (sPAP), but due various limitations, this technique is not considered to be sufficiently accurate for the diagnosis of PH. The aim of 4D flow MRI is to evaluate the complete time-varying tridirectional velocity field in a volume of interest. It enables flow and velocity measurements in a vascular region of interest and visualization of vector plots of blood flow velocity fields. Previous studies have shown on the one hand, correlations between mPAP and hemodynamic parameters obtained by phase contrast MRI and, on the other hand, appearance of a vortical blood flow in the pulmonary artery in PH. More studies are required to confirm 4D MRI as a valuable tool for mPAP estimation in PH. Following screening echocardiography, all patients will undergo right heart catheterization for PH assessment. Then, all patients will be referred for a complete cardiac MRI exam with the addition of a 4D Flow sequence (does not require supplementary injection of a contrast agent and does not extend the duration of the examination) followed promptly (within the same hour) by a Doppler-echocardiography. The data from each examination will be blindly interpreted from the results of the other one. No follow-up will be required for the study.

NCT ID: NCT05096819 Completed - Clinical trials for Pulmonary Hypertension

Evaluation of the Usefulness of Adopting Remote, Mobile-based 6MWT Among Hospital Outpatients (the 6-APPnow), Within the Constraints Imposed by the SARS-COV2 Pandemic

6-APPnow
Start date: September 1, 2021
Phase:
Study type: Observational

The six-minute walk test (6MWT) is a standard method for measuring exercise capacity in patients with cardiopulmonary disease such as pulmonary hypertension (PAH) and measures how far a patient can walk in 6 minutes. The test is usually performed in the hospital, by walking along a hospital corridor. Since the outbreak of SARS-CoV-2, there has been a need to minimise patient contact with hospitals and their staff to reduce transmission of the virus. In a previous research project called 6APP, the investigators designed, developed and evaluated a mobile phone app, to allow them to perform the 6MWT in the community. Given the current circumstances, cardiovascular outpatients including patients in the PAH clinic at Oxford University Hospitals are being recommended to use an app derived from that project to provide their 6MWT distance to the clinical team for assessment, in addition to their symptoms and general well-being. This is felt to be more appealing to the patients, and would reduce the time spent in hospital on the day of their outpatient appointment. The investigators plan to measure the usefulness of adopting remote, mobile-based 6MWT among hospital outpatients, within the constraints imposed by the SARS-COV2 pandemic.

NCT ID: NCT05082272 Completed - Clinical trials for Pulmonary Hypertension

The Role of Transthoracic Echocardiography in Diagnosis of Pulmonary Hypertension of Infants With Bronchopulmonary Dysplasia

Start date: January 1, 2016
Phase:
Study type: Observational

Pulmonary hypertension may develop in premature newborn infants due to impaired lung development. The diagnosis of this disease can actually be made with interventional methods. In this study, we evaluated the importance of echocardiographic examination and blood laboratory tests in diagnosing this disease.

NCT ID: NCT05001711 Completed - Clinical trials for Pulmonary Hypertension

Acute Assessment of the Aria CV System in Patients With WHO Groups 2 and 3 Pulmonary Hypertension

Start date: July 12, 2021
Phase: N/A
Study type: Interventional

This study is a prospective, non-randomized, two arm, single-center acute feasibility study assessing safety and performance of the Aria CV Acute PH System in WHO Group 2 and 3 PH patients.

NCT ID: NCT04903704 Completed - Clinical trials for Pulmonary Hypertension

Pulmonary Hypertension and Measurement of Exercise Capacity Remotely

PERSPIRE
Start date: June 8, 2021
Phase: N/A
Study type: Interventional

Background Hospital-based walking exercise tests are routinely used in patients with pulmonary hypertension to assess functional ability and disease progression over time. We are seeing a greater emphasis on non-face-to-face clinical assessments, where such tests cannot be conducted. It is important to identify alternative tests which can be which can be conducted by patients at home and used to support clinical decision making. Aim To test the safety of the 1-minute sit-to-stand test in patients with pulmonary hypertension and its comparability with hospital-based walking exercise tests. Methods A sample of 75 patients attending hospital appointments will carry out an Incremental Shuttle Walk Test, followed by a 1-minute sit-to-stand test after a 30 minute rest. Data will be analysed for safety and comparability between the 2 tests. In the event of favourable findings (safety and comparability) from the hospital-based testing, a further sample of patients will be asked to perform the 1-minute sit-to-stand test in the home setting

NCT ID: NCT04891354 Completed - Clinical trials for Pulmonary Hypertension

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

Start date: February 2, 2021
Phase: Phase 1
Study type: Interventional

This is a first-in-human, 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. There are 2 parts to the study: Part I: single ascending dose (SAD), 7 cohorts, 30 minutes intravenous (i.v.) infusion of placebo followed by 1-hour i.v. 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 i.v. 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 i.v. infused for 30 minutes whereas the last will be i.v. 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.

NCT ID: NCT04792879 Completed - Clinical trials for Pulmonary Hypertension

Assessment of Peripheral Veins Doppler Ultrasound for Diagnosis of Acute Right Heart Failure in Suspicion or Follow-up of Pulmonary Hypertension

CODOVEIN
Start date: June 14, 2021
Phase: N/A
Study type: Interventional

Occurrence of acute right heart failure (ARHF) remains common during pulmonary hypertension (PH). Right atrial pressure (RAP) invasive measurement is the gold standard to diagnose ARHF in order to improve diuretic treatment management. Existence of indirect signs of ARHF on venous Doppler ultrasound waveform has long been described, but correlation with RAP has not been properly established yet. It is the aim of our study in order to obtain an additional tool to manage ARHF.