Last reviewed · How we verify
NCT06060366: IPES
Impact of Pulmonary Endarterectomy on Sleep-Related Breathing Disorders in CTEPH: The IPES Trial
trial testing Pulmonary endarterectomy in Sleep-Disordered Breathing in 100 participants. Status unknown.
20 August 2024
Quick facts
| Lead sponsor | Marmara University |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 100 |
| Start date | 20 December 2023 |
| Primary completion | 20 August 2024 |
| Estimated completion | 20 November 2024 |
| Sites | 1 location across Turkey (Türkiye) |
Drugs / interventions tested
- Pulmonary endarterectomy
Conditions studied
- Sleep-Disordered Breathing — all drugs for Sleep-Disordered Breathing →
- Chronic Thromboembolic Pulmonary Hypertension — all drugs for Chronic Thromboembolic Pulmonary Hypertension →
- Post Operative — all drugs for Post Operative →
Sponsor
Marmara University
Who can join
18 and older, any sex, with Sleep-Disordered Breathing or Chronic Thromboembolic Pulmonary Hypertension. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Pulmonary hypertension (PH) has three main types, pre-capillary PH, post-capillary PH, and combined pre-capillary and post-capillary PH, and it is based on mean pulmonary arterial pressure (PAP) \> 20 mmHg measured with a right heart catheterization (RHC). Chronic thromboembolic pulmonary hypertension (CTEPH) is mainly defined as a pre-capillary PH and classed as a Group IV PH. It was reported that 0.1-9.1% of individuals with pulmonary embolism develop CTEPH within two years after the initial diagnosis, and CTEPH is the only PH category that has a chance of being cured, mainly by pulmonary endarterectomy. Sleep-related breathing disorders (SRBD) are defined as obstructive sleep apnea (OSA) disorders, central sleep apnea (CSA) syndromes, sleep-related hypoventilation disorders, and sleep-related hypoxemia. An SRBD may also lead to an increase in PAP primarily during sleep and cause nocturnal hypoxemia. Although SRBDs were reported in patients with pre-capillary PH, most of the studies included patients with idiopathic PAH. Although the cause-and-effect relationship between pre-capillary PH and SRBDs is uncertain, it is known that mPAP may increase during sleep in patients with OSA . Less is known regarding the occurrence of SRBDs in CTEPH. Previously a few study showed relationship between SRBDs an CTEPH as the main type was OSA. Most of the studies evaluated preoperative occurance and incidance of SRBDs in CTEPH. Only one study performed post operative SRBD on a cardiorespiratory device was conducted the night before and one month after elective pulmonary endarterectomy. In our previous study we showed that severe nocturnal hypoxemia (NH) is highly prevelant in preoperative CTEPH patients and the most common two types of SRBD are OSA and isolated sleep related hypoxemia (ISRH) and age, mPAP and AHI are independent determinants of severe NH. (J. Clin. Med. 2023, 12, 4639 https://doi.org/10.3390/jcm12144639) In this present study we aimed to investigate occurrence of SRBDs and mortality 5 years after pulmonary endarterectomy operation.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06060366
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Pulmonary endarterectomy
Trials testing the same drug.
- NCT07254078 — Registry of Patients With chrOnic thromboemboLic Pulmonary hypErTension · recruiting
- NCT05110066 — BPA vs. PEA in CTEPH · NA · recruiting
- NCT03273257 — Riociguat in Patients With Operable CTEPH Prior to Pulmonary Endarterectomy (PEA Bridging Study) · Phase 2 · terminated
Other recruiting trials for Sleep-Disordered Breathing
Currently open trials in the same condition.
- NCT07147803 — Sleep Quality in Patients With Non-cystic Fibrosis Bronchiectasis · active not recruiting
- NCT06576830 — Optimization of Pediatric Tonsillectomy to IMprove AnaLgesia · Phase 4 · recruiting
- NCT06255613 — Validation of Belun Ring Gen3 Deep Learning Algorithms With Subxiphoid Body Sensor · NA · active not recruiting
- NCT06498544 — HighCycle Study: Effect of High Altitude on Sleep Disordered Breathing in Women Related to Their Menstrual Cycle Phase · recruiting
- NCT06498531 — HighCycle Study: Effect of Acetazolamide on Sleep Disordered Breathing in Women Compared to Men · Phase 4 · recruiting
Other Marmara University trials
Trials by the same sponsor.
- NCT07533734 — The Effects of an Augmented Reality-Based Mirror Therapy System in Patients With Stroke · NA · not yet recruiting
- NCT07474181 — Simulation-Based Training for Urinary Catheterization Skills in Nursing Students · NA · not yet recruiting
- NCT07486349 — Shoulder Pericapsular Block Versus Interscalene Block in Arthroscopic Shoulder Surgery · NA · not yet recruiting
- NCT07468110 — Evaluation Of The Relationship Between The Conut Score And Balance And Functional Status In Patients With Chronic Stroke · recruiting
- NCT07468097 — The Impact of Metabolic Status on Pain and Central Sensitization in Women With Lipedema: A Cross-Sectional Observational · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06060366 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Marmara University
- Last refreshed: 4 October 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06060366.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing