Observatory: Search for Prognostic Factors of Pulmonary Hypertension Post-capillary in Heart Failure

Completed

• Conditions: Heart Failure; Post-capillary Pulmonary Hypertension

• Registration Number: NCT01545180
• Lead Sponsor: French Cardiology Society

Brief Summary

This study will better understand the post-capillary pulmonary hypertension in heart failure, to determine its prognostic role and to consider specific treatment of different forms of pulmonary hypertension in post-capillary pulmonary heart failure.

Detailed Description

Patients with heart failure (HF) frequently have a post-capillary pulmonary hypertension (HTPcap) which has two forms: passive and reactive.

The prognosis, prevalence and pathophysiological mechanisms of cell and tissue involved in the onset and reversibility of these two forms of HTPcap remain poorly understood.

The latest recommendations of the European Society of Cardiology and the European Respiratory Society identify two forms of HTPcap in the IC as a function of the extent of trans-pulmonary gradient (GTP) measured during right heart catheterization (GTP = mPAP-Pcap): passive (GTP £ 12mmHg) and reactive (GTP\> 12mmHg).

In the latter form, the increase in pulmonary pressure would be disproportionate to the increase in left ventricular pressures.

This study will permit to identify hemodynamic prognostic markers of the the IC, and clinical, biological and hemodynamic determinants of the HTPcap in the IC.

This will help to identify a population that could benefit from specific treatment to referred pulmonary artery.

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-02-29
• Study First Submitted QC: 2012-03-05
• Study First Posted: 2012-03-06
• Primary Completion: 2018-12
• Study Completion: 2020-12-31
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-20
• Last Update Posted: 2022-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 665

Inclusion Criteria

• Patient with heart failure (LVEF preserved or altered or valvular heart disease) defined by a history of heart failure or LVEF less than or equal to 50%.
• Patient with a right heart catheterization for medical reasons
• Medical treatment considered optimal: beta blockers, ACE inhibitors or angiotensin II receptor antagonists and/or aldosterone
• Stable Patient: No significant cardiac decompensation or change the dose of diuretics for 28 days.
• The patient has agreed and have signed consent.

Exclusion Criteria

• Patient is younger than 18 years.
• Patient with unstable heart failure (cardiogenic shock, acute cardiac decompensation).
• Coronary heart disease for which there is a maximum revascularization
• Organic valvular which is scheduled for surgical correction of valvular abnormality (plasty or replacement).
• Patient dialysis.
• PAH original pre-capillary catheterization, defined by a Pcap ≤ 15 mmHg.
• Patient with triple installation of PM within 90 days.
• Patients who underwent revascularization within 90 days.
• Patients who underwent mechanical ventricular assistance.
• Patient with severe lung infection (CPT < 60% of predicted, FEV < 60% predicted) or pulmonary embolism or respiratory failure with a paO2 in ambient air below 60mmHg or oxygen therapy.
• Patient with severe heart rhythm.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prognostic	2 years	Estimate the prognosis of different forms of HTPcap in heart failure (ejection fraction altered, stored or valvular heart disease)

Secondary Outcome Measures

Name	Time	Method
Prevalence	3 years	Define the prevalence of different forms of active or passive HTPcap
Phenotype	3 years	Define the phenotypic characteristics of patients with reactive or passive HTPcap in heart failure

Trial Locations

Locations (1)

Henri Mondor Hospital; 🇫🇷 Creteil, France