The Right Ventricle in Chronic Pressure Overload: Identifying Novel Molecular Targets for Functional Imaging

NCT03199131 | Completed DMC

• 1 other identifier: 2015-A00149-40
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Chronically elevated pulmonary pressures do not immediately result in right ventricular failure. During the initial period of exposure, the RV adapts to the increased afterload by altering its metabolism and morphology so as to meet the increased work requirement. Several, interconnected adaptive mechanisms have been proposed, including myocyte hypertrophy, a switch in the primary fuel used for ATP generation, increased angiogenesis, and decreased production of mitochondrial reactive oxygen species. While adaptation is initially successful in many cases, it is temporary, and after an uncertain period of time, the ventricle begins to fail. This transition from a compensated to decompensated state is difficult to predict clinically, and patients with different etiologies of CPOS progress to overt RV failure over significantly different time periods. This variability hinders the implementation of treatments that are tailored to a specific disease stage.

Conditions

Chronic Thromboembolic Pulmonary Hypertension

Outcome Measures

Primary Outcomes (1)

• relationship between the metabolic, morphologic and functional alterations in the right ventricle

  to investigate the relationship between the metabolic, morphologic and functional alterations in the right ventricle before surgery,one and six months after surgery.

Secondary Outcomes (1)

• validation in human subjects of metabolic signaling pathway alterations found in animal model

  analyse gene and protein expression during surgery

Study Arms (2)

CTEPH

EXPERIMENTAL

Patients undergoing pulmonary endarterectomy for the treatment of chronic thromboembolic pulmonary hypertension (CTEPH).

Procedure: Right ventricular biopsies

Control group

OTHER

Patients undergoing adult cardiac surgery without evidence of pulmonary hypertension.

Procedure: Right ventricular biopsies

Interventions

Right ventricular biopsies PROCEDURE

a right ventricular biopsy will be taken intraoperatively during either pulmonary endarterectomy (experimental group) or open cardiac surgery (control group).

CTEPH; Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic thromboembolic pulmonary hypertension group:
• Patients undergoing pulmonary endarterectomy at Marie Lannelongue Surgical Center for the treatment of chronic thromboembolic pulmonary hypertension.
• Control group:
• Patients undergoing adult cardiac surgery without evidence of pulmonary hypertension on preoperative assessment

You may not qualify if:

• Chronic thromboembolic pulmonary hypertension group:
• Insufficient biopsy material,
• pre-operative therapy with bosentan or sildenafil
• Control group:
• Insufficient biopsy sample,
• ischemic cardiomyopathy,
• miral or tricuspid valve disease,
• pre-operative pulmonary hypertension.

Sponsors & Collaborators

• Centre Chirurgical Marie Lannelongue: lead

Study Sites (1)

Centre Chirurgical Marie Lannelongue

Le Plessis-Robinson, 92350, France

Location

Study Officials

• Olaf Mercier, MD, PhD

  Marie Lannelongue Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2017
• First Posted: June 26, 2017
• Study Start: February 20, 2017
• Primary Completion: November 20, 2017
• Study Completion: October 20, 2018
• Last Updated: January 23, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)