International CTEPH Registry
Research type
Research Study
Full title
New International CTEPH Database (International CTEPH Registry)
IRAS ID
176889
Contact name
Joanna Pepke-Zaba
Contact email
Clinicaltrials.gov Identifier
176889/790932/20/529, NIHR Portfolio Adoption
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
Summary of Research
The New International Chronic thromboembolic pulmonary hypertension (CTEPH) Database is a prospective registry collecting data on patients diagnosed with CTEPH in specialized centers worldwide. CTEPH is a form of pulmonary hypertension where the blood pressure in the pulmonary arteries becomes higher than normal (pulmonary hypertension). Patients undergo clinical assessments and receive standard medical care, as determined by the patient’s doctors. Patients do not receive experimental intervention or treatment as a consequence of their participation in the registry. The New International CTEPH Registry, does not provide a therapy protocol.As this is a real world observational, non-interventional study, the frequency of visits is determined by the doctors and by the health care needs of the patients.
Key objectives of the Registry are:
Describe epidemiology of CTEPH, mode of diagnosis and treatment worldwide:
.Time span between onset of symptoms and diagnosis
. How are patients with CTEPH globally diagnosed and treated?
. Are they on Pulmonary hypertension (PH) therapy at time of diagnosis?
. How are they being treated after diagnosis?Determine long-term outcome as measured by New York Health Association (NYHA) and survival in all patients in different treatment groups.
The purpose of the New CTEPH Registry is to better understand the medical management of patients with CTEPH under routine medical care. Data generated through this Registry shall support a better understanding of CTEPH, and inform national and international diagnosis and treatment guidelines leading to improved patient care in the long term.
Summary of Research
New International CTEPH Database (NCT02656238) The New International CTEPH Database is a study in CTEPH – which stands for chronic thromboembolic pulmonary hypertension. CTEPH is a condition in which blood clots block the blood vessels in the lungs. This causes stress on the heart and can lead to heart failure if patients do not receive treatment in time. The International CTEPH Association (ICA) was the sponsor of this study. The ICA is a non-profit association of doctors. The ICA set up this study because they wanted to find out what treatments people with CTEPH received and how many patients died depending on what treatment they had. This summary explains how researchers ran the study and what its results were.
The ICA received funding for the study from 2 pharmaceutical companies, Bayer AG and Actelion (now Janssen) Pharmaceuticals. The ICA made all the decisions concerning the study. ICA researchers are the only people who have access to the study data.
The patients in the study received the same treatments that they would have received if they had not participated in the study. These treatments can be a) surgery to remove blood clots from large vessels in the lungs, b) the use of a small balloon to unblock smaller blood vessels (balloon pulmonary angioplasty) or c) drugs. Patients can also receive a combination of these treatments. During the study, patients visited their doctors as they would do normally. The doctors collected information on the patients’ health and entered it into the study database.
Patients could enter the study from February 2015 to September 2016. Data collection continued for a further 3 years, until September 2019. The study included 1009 patients from 34 centres in 20 countries. All patients in the study were newly diagnosed with CTEPH – with symptoms associated with the blockage within the vessels of their lungs. The average age of patients when they were diagnosed was 63 years. About 8 out of 10 patients were from Europe, 1 out of 10 from Japan, and 1 out of 10 from other countries. Half of the patients were men. 2 out of 3 of the patients had experienced a known blood clot to the lungs (pulmonary embolism) at some point in the past. The remaining patients either had no blood clot before diagnosis of CTEPH, or they had one, but their doctor missed it. The daily activities of about 3 out of 4 patients were severely limited because of the clots in their lungs.
At the end of the study, 6 out of 10 patients had undergone surgery and 2 out of 10 patients had received treatment with a balloon, and 2 out of 10 patients had received only drugs or no treatment at all. In the surgery group, 93 out of every 100 patients were still alive at the end of the study. In the balloon group, 90 out of every 100 patients were still alive at the end of the study. In the group without surgery or balloon treatment, 73 out of every 100 patients were still alive at the end of the study.
This study shows that more patients survive if they have surgery or balloon treatment than if they receive only drugs or no treatment at all. This confirms what other studies before this study have shown. This is important for health care providers to know for when they encounter patients with CTEPH.
In recent years, the management of patients with CTEPH has changed. Many patients receive combinations of surgery and balloon treatment, surgery and drug treatment, or balloon and drug treatment. The most suitable treatment for a patient depends on where in the lungs the blood vessels are blocked. The ICA is planning a further study to find out how expert centres combine different treatments and how many patients survive with each combination treatment.
The researchers would like to thank all people who participated in the New International CTEPH Database.
If you would like to know more about the study, you can find further information at https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbUA2h16NAEhOMbjajk9tQAjkQ-2FQCWJl2ELtqaXXxpL-2F6C0CJ5q8j-2F9m-2FDrNQP5Zujq-2BiDkqlLtAQErzhtsbtoU0-3DXRn7_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YIO8x-2BD8WE-2BKhC1JPS9aIgd5duFZu6msLeoCOiFp1XC6ZhEQFq-2Fq3ALgkkEat76Up6yJS3LJy6UdbJCci7eLQM8GVgj4u90aEKTk2hcmgpmQv22snZq4VzzRrVCx7IwQXU7LOSvB-2FmJUW3MGyGRU9qKmKzD-2BwUQMzYT2-2BG47c1p6A-3D-3D&data=05%7C01%7Capprovals%40hra.nhs.uk%7C43a23b156dae4590a84108da60b516b9%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C637928628127280101%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=v%2Fj5EG7KZKA%2BorAAVMWrzjZ2X2vVoX5E81l113mhPnw%3D&reserved=0 or at https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbRehJ-2Fi4xyo44sEgJVCl5BcbW9wgc64X2JjNxW-2BqMpAMlmUp3dyskFG2FE2G-2B6WwoQ-3D-3Dz9-L_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YIO8x-2BD8WE-2BKhC1JPS9aIgd8A-2BQ1CtZByj0YiIrvODXW7sER0cBxtrXxR65Vwzy2G-2BuYapNOwx6AcpglRdttpHvbQz2lo9RKx2awCE-2Bi-2BnFBRTeerAaRPKZqZg7iW2ONWydLgiigK8ykXjXZ-2FR-2FZMAhN20WTsT-2FFGqK7CQdtnzAqA-3D-3D&data=05%7C01%7Capprovals%40hra.nhs.uk%7C43a23b156dae4590a84108da60b516b9%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C637928628127280101%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=sDElR5N4NY9EAGtx6oelGtJbNl1x8AG8je4OSpsTQGw%3D&reserved=0 Initial results of the study have been published in a scientific journal: S. Guth et al., Current strategies for managing chronic thromboembolic pulmonary hypertension: results of the worldwide prospective CTEPH Registry. ERJ Open Res 2021;7:00850-2020 (DOI: 10.1183/23120541.00850-2020; https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbeGbmQmMfeY6MTsuMZ7e1y4ebGYG5Uy9n-2FUEEJwx9KRrB0shWYq7ok32Wy2DL2KQYgAajaSnRYKfQCksBVmhFGo-3D4shH_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YIO8x-2BD8WE-2BKhC1JPS9aIgdO5rBc-2BTpLQ54u5nGc3CKUTi3WX2UQjgTlHtZOZrvil2Y9sKS3xVOu-2BD4fJbgSXevj7t1ktIqGxKqcIHuvfHRTRvtGpGuW8uuQe3ombkedi-2B6kj0aIhUzFBPLhl1D4HY7124mJrOQHkGHNPRTgfEEbw-3D-3D&data=05%7C01%7Capprovals%40hra.nhs.uk%7C43a23b156dae4590a84108da60b516b9%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C637928628127280101%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=uE8GyeqpYCSHxJEyv5L5aO%2FJwfsOy7FkVzcc1nr0G68%3D&reserved=0
If you would like to know more about the ICA, you can find further information at https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbUA2h16NAEhOMbjajk9tQAhP7mvJ4DSU8Yjt2B7Vl4KYGS9d_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YIO8x-2BD8WE-2BKhC1JPS9aIgdUjhktzvrzDPMAo5y4s-2F85-2FhR8c6zn1lm6x7ic-2F7t9-2Fy3p8wfJ-2Bl1DwuyGBxoCKVbkcNRwPfp5IUY736VyoG49LoGnndVfk0REPLLsE-2FeKY-2FrbwxQ04Or53e-2B-2BdDjPkmkNkHhSc0tioa6sIsYMr0nyA-3D-3D&data=05%7C01%7Capprovals%40hra.nhs.uk%7C43a23b156dae4590a84108da60b516b9%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C637928628127280101%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=FnbBAiK3yBE60IesK%2FeeFm8mx1dLnjQQd3juB4orYe8%3D&reserved=0 You can contact the ICA at info@cteph-association.org.REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
15/WM/0226
Date of REC Opinion
19 Jun 2015
REC opinion
Favourable Opinion