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

NCT ID: NCT01545180

Last Updated: 2022-09-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 665 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2020-12-31

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.

Conditions

Heart Failure; Post-capillary Pulmonary Hypertension

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

HTPcap in IC

HTPcap active and passive in a population of stable patients with heart failure (left ventricular ejection fraction impaired or preserved) and / or valvular disease who received a left right heart catheterization as part of their care.

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CHRU Lille, Dr Nicolas LAMBLIN

UNKNOWN

Sponsor Role: collaborator

French Cardiology Society

OTHER

Sponsor Role: lead

Responsible Party

Thibaud Damy

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thibaud DAMY

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Henri Mondor Hospital

Créteil, , France

Countries

France

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Other Identifiers

11415

Identifier Type: -

Identifier Source: org_study_id