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CTEPH clinical trials

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NCT ID: NCT06105242 Recruiting - CTEPH Clinical Trials

Biological Sex and CTEPH-related RV Dysfunction and Recovery (BIOSPHeRe)

Start date: May 30, 2022
Phase:
Study type: Observational [Patient Registry]

1. To identify biological sex differences in baseline RV function in CTEPH 2. To identify biological sex differences in recovery of RV function after PTE surgery in CTEPH 3. To determine if sex hormone levels relate to RV function at CTEPH diagnosis and during recovery after PTE.

NCT ID: NCT05629052 Recruiting - Clinical trials for Chronic Thromboembolic Pulmonary Hypertension

TrEatment Approach in the Multimodal Era Registry

TEAM
Start date: April 12, 2023
Phase:
Study type: Observational [Patient Registry]

The goal of this observational patient registry is to learn how expert centers treat patients with chronic thromboembolic pulmonary hypertension (CTEPH). CTEPH is a condition in which blood clots block the blood vessels in the lungs. There are currently three treatment options for patients with CTEPH: - surgery to remove blood clots from large vessels in the lungs (pulmonary endarterectomy (PEA)) - the use of a small balloon to unblock smaller blood vessels (balloon pulmonary angioplasty (BPA)) - drugs Patients can also receive a combination of these treatments. The main question this registry aims to answer are: - How many patients receive a given kind of treatment? - How do expert centers combine the different treatments? - Are patients doing better after they receive a given kind of treatment? - How many patients are alive 1, 3 and 5 years after they receive a given kind of treatment? Participants will receive the same treatments that they would receive if they did not participate in the study. During the study, patients will visit their doctors as they would do normally. The doctors will collect information on the patients' health and enter it into the study database. The follow-up time will be at least 3 years for all patients.

NCT ID: NCT05480137 Recruiting - CTEPH Clinical Trials

OCT Evaluates the Effects of CTEPH Treated by Scoring Balloon

Start date: August 30, 2020
Phase: N/A
Study type: Interventional

Chronic thromboembolic pulmonary hypertension (CTEPH) is a disease of obstructive pulmonary artery remodelling as a consequence of major vessel thromboembolism. The diagnosis of CTEPH is based on findings obtained after at least 3 months of effective anticoagulation in order to discriminate this condition from subacute PE. These findings are mean pulmonary artery pressure ≥25mmHg with pulmonary artery wedge pressure ≤15 mmHg, mismatched perfusion defects on lung scan and specific diagnostic signs for CTEPH seen by multidetector CT angiography, MR imaging or conventional pulmonary cineangiography, such as ring-like stenoses, webs/slits and chronic total occlusions (pouch lesions or tapered lesions). Balloon pulmonary angioplasty (BPA) is a type of effective treatment for CTEPH. Plain balloon is usually used in BPA surgery,however,the efficacy and safety of NSE scoring balloon in BPA is not clear. Optical coherence tomography(OCT)as a good assessment methods has been reported. Our study aims to explore the efficacy and safty of NSE scoring balloon based on OCT in BPA .

NCT ID: NCT05140525 Not yet recruiting - CTEPH Clinical Trials

Effects of Combination Medical Therapy Followed by BPA on Right Ventricular-PA Coupling and Hemodynamics in CTEPH

EPIPHANY
Start date: May 31, 2024
Phase: Phase 3
Study type: Interventional

The main goal of this study is to determine the effects of combination medical therapy (Riociguat and Macitentan) and balloon pulmonary angioplasty (BPA) on hemodynamics and right ventricular (RV) function (including advanced assessments of RV-pulmonary artery (PA) coupling from invasive hemodynamics) in participants with inoperable or post-PTE residual CTEPH.

NCT ID: NCT04730037 Completed - CTEPH Clinical Trials

Clinical Trial to Investigate Safety and Efficacy of Edoxaban in Patients With CTEPH (KABUKI)

Start date: March 23, 2021
Phase: Phase 3
Study type: Interventional

This is phase III trial to evaluate whether edoxaban, a direct factor Xa inhibitor, is noninferior to warfarin in preventing worsening of chronic thromboembolic pulmonary hypertension (CTEPH).

NCT ID: NCT04207593 Completed - Clinical trials for Pulmonary Arterial Hypertension

The Effect of Oxygen Therapy on 6MWD in PAH and CTEPH Patients With Hypoxemia

SOPHA
Start date: April 1, 2019
Phase: Phase 2
Study type: Interventional

Treatment of O2 naïve patients with PAH will be included in this investigator-initiated trial (IIT) to assess efficacy and safety of oxygen substitution. Nocturnal oxygen substitution improved the 6MWD compared to placebo in one clinical trial in PAH patients. Due to the positive results in the treatment of patients with PAH, the initiation of this proof-of-concept study is justified.

NCT ID: NCT03953560 Completed - Pulmonary Embolism Clinical Trials

Symptom-related Screening for Early Detection of CTEPH.

Start date: January 16, 2019
Phase: N/A
Study type: Interventional

Routine screening for Chronic thromboembolic pulmonary hypertension (CTEPH) i after PE is not supported by current evidence and guidelines. This study aims to evaluate if a screening program for patients with acute PE based on telephone monitoring of symptoms and further examination if only symptomatic patients could help an early detection of CTEPH.

NCT ID: NCT03273257 Terminated - Clinical trials for Chronic Thromboembolic Pulmonary Hypertension

Riociguat in Patients With Operable CTEPH Prior to Pulmonary Endarterectomy (PEA Bridging Study)

Start date: August 17, 2018
Phase: Phase 2
Study type: Interventional

This is a randomised, double-blind, placebo-controlled, multicentre, multinational, prospective study in patients with operable chronic thromboembolic pulmonary hypertension (CTEPH) prior to pulmonary endarterectomy (PEA) with high preoperative pulmonary vascular resistance (PVR). Patients will be randomised in a 1:1 ratio to receive riociguat or matching placebo for 3 months before undergoing PEA. The primary objective of this study is to assess the efficacy of riociguat on preoperative PVR compared to placebo in patients with operable CTEPH.

NCT ID: NCT03245268 Completed - Clinical trials for Chronic Thromboembolic Pulmonary Hypertension

International BPA Registry

Start date: March 2, 2018
Phase:
Study type: Observational [Patient Registry]

The International Balloon Pulmonary Angioplasty (BPA) Registry is a prospective, multi-center, long-term observational project. Scheduled to start data collection in Q4 2017, the registry will run for approximately four years with a follow-up time for each patient of at least two years. Its primary objective is to investigate the efficacy and safety of BPA intervention in patients with chronic thromboembolic pulmonary hypertension (CTEPH) not amenable to pulmonary endarterectomy (PEA).

NCT ID: NCT03083093 Completed - Pulmonary Embolism Clinical Trials

CTEPH Identification an Standard Computerised Tomography Pulmonary Angiography in Pulmonary Embolism Patients

InShapeIII
Start date: May 1, 2017
Phase:
Study type: Observational

In this study the investigators will evaluate whether more careful reading (than the current standard) of routine computerised tomography pulmonary angiography (CTPA) performed in the clinical work-up of suspected (pulmonary embolism (PE) will differentiate patients with acute PE from those with more chronic or acute on chronic PE, which could be indicative of the presence of chronic thromboembolic pulmonary hypertension (CTEPH)"