Clinical trial NCT01545180: Observatory: Search for Prognostic Factors of Pulmonary Hypertension Post-capillary in Heart Failure
Official title: Observatory: Search for Prognostic Factors of Pulmonary Hypertension Post-capillary in Heart Failure.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Post-capillary Pulmonary Hypertension
Keywords: Observatory
Heart failure
Post-capillary pulmonary hypertension
HTPcap
Lead sponsor: French Cardiology Society
Sponsor class: OTHER
Collaborators: name: CHRU Lille, Dr Nicolas LAMBLIN
First posted: 2012-03-06
Enrollment: 665
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inclusion of consecutive patients recruted from cardiology departments for all participating centres. Participation in the study is offered to all French institutions (academic hospitals, general hospitals, army hospitals and private clinics) with cardiology units. A physician is responsible for study recruitment at each centre.

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.

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.

Primary outcomes:
measure: Prognostic
timeFrame: 2 years
Secondary outcomes:
measure: Prevalence
timeFrame: 3 years
measure: Phenotype
timeFrame: 3 years
Other outcomes:
Locations:
city: Creteil
country: France
facility: Henri Mondor Hospital
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Thibaud DAMY
role: PRINCIPAL_INVESTIGATOR
References:
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