NCT06060366

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 23, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 29, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

December 20, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2024

Completed
Last Updated

October 4, 2023

Status Verified

October 1, 2023

Enrollment Period

8 months

First QC Date

September 23, 2023

Last Update Submit

October 1, 2023

Conditions

Sleep-Disordered BreathingChronic Thromboembolic Pulmonary HypertensionPost Operative

Outcome Measures

Primary Outcomes (1)

  • Mortality

    mortality of patients who were or operated or followed up by medical treatment

    5 years

Secondary Outcomes (2)

  • Type of Sleep-Related Breathing Disorders

    5 years

  • systolic pulmonary arterial pressure (sPAP)

    5 years

Study Arms (2)

PE for CTEPH

CTEPH patients who were eligible for operation

Procedure: Pulmonary endarterectomy

Medical treatment CTEPH

CTEPH patients who were not eligible for surgery of any reason and decided to follow up with medical treatment

Interventions

Pulmonary endarterectomyPROCEDURE

removal of chronic thrombus from pulmonary arterial system

PE for CTEPH

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Study population will be the same in our previous which was mentioned above

You may qualify if:

  • Previously diagnosed with CTEPH according to radiology and right heart catheterization and eligible for surgery
  • Polisomnography test
  • Includes both criteria above

You may not qualify if:

  • do not volunter for study
  • exitus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University School of Medicine

Istanbul, Turkey (Türkiye)

Location

Related Publications (6)

  • Simonneau G, Montani D, Celermajer DS, Denton CP, Gatzoulis MA, Krowka M, Williams PG, Souza R. Haemodynamic definitions and updated clinical classification of pulmonary hypertension. Eur Respir J. 2019 Jan 24;53(1):1801913. doi: 10.1183/13993003.01913-2018. Print 2019 Jan.

    PMID: 30545968RESULT

  • Badesch DB, Raskob GE, Elliott CG, Krichman AM, Farber HW, Frost AE, Barst RJ, Benza RL, Liou TG, Turner M, Giles S, Feldkircher K, Miller DP, McGoon MD. Pulmonary arterial hypertension: baseline characteristics from the REVEAL Registry. Chest. 2010 Feb;137(2):376-87. doi: 10.1378/chest.09-1140. Epub 2009 Oct 16.

    PMID: 19837821RESULT

  • Madani MM. Pulmonary endarterectomy for chronic thromboembolic pulmonary hypertension: state-of-the-art 2020. Pulm Circ. 2021 May 24;11(2):20458940211007372. doi: 10.1177/20458940211007372. eCollection 2021 Apr-Jun.

    PMID: 34104418RESULT

  • La Rovere MT, Fanfulla F, Taurino AE, Bruschi C, Maestri R, Robbi E, Maestroni R, Pronzato C, Pin M, D'Armini AM, Pinna GD. Chronic thromboembolic pulmonary hypertension: Reversal of pulmonary hypertension but not sleep disordered breathing following pulmonary endarterectomy. Int J Cardiol. 2018 Aug 1;264:147-152. doi: 10.1016/j.ijcard.2018.02.112.

    PMID: 29776563RESULT

  • Berry RB, Budhiraja R, Gottlieb DJ, Gozal D, Iber C, Kapur VK, Marcus CL, Mehra R, Parthasarathy S, Quan SF, Redline S, Strohl KP, Davidson Ward SL, Tangredi MM; American Academy of Sleep Medicine. Rules for scoring respiratory events in sleep: update of the 2007 AASM Manual for the Scoring of Sleep and Associated Events. Deliberations of the Sleep Apnea Definitions Task Force of the American Academy of Sleep Medicine. J Clin Sleep Med. 2012 Oct 15;8(5):597-619. doi: 10.5664/jcsm.2172.

    PMID: 23066376RESULT

  • Cinar C, Yildizeli SO, Balcan B, Yildizeli B, Mutlu B, Peker Y. Determinants of Severe Nocturnal Hypoxemia in Adults with Chronic Thromboembolic Pulmonary Hypertension and Sleep-Related Breathing Disorders. J Clin Med. 2023 Jul 12;12(14):4639. doi: 10.3390/jcm12144639.

    PMID: 37510754RESULT

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Sehnaz Olgun Yildizeli, Assoc Prof

    ICJME

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sehnaz Yildizeli, Assoc Prof

CONTACT

+905052693141drsehnazolgun@yahoo.com

Bedrettin Yildizeli, Prof

CONTACT

+905323533521byildizeli@marmara.edu.tr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2023

First Posted

September 29, 2023

Study Start

December 20, 2023

Primary Completion

August 20, 2024

Study Completion

November 20, 2024

Last Updated

October 4, 2023

Record last verified: 2023-10

Locations

TU(1)