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

Sponsor

French Cardiology Society (Other)

Overall Status

Unknown status

CT.gov ID

NCT01545180

Collaborator

CHRU Lille, Dr Nicolas LAMBLIN (Other)

665

Enrollment

Location

106

Anticipated Duration (Months)

6.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure Post-capillary Pulmonary Hypertension

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 Design

Study Type:

Observational

Actual Enrollment :

665 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Feb 1, 2012

Actual Primary Completion Date :

Dec 1, 2018

Anticipated Study Completion Date :

Dec 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.