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Completed

NCT Number: NCT01545180

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Henri Mondor Hospital

Créteil, 94000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Prognostic

    Time frame: 2 years

    Estimate the prognosis of different forms of HTPcap in heart failure (ejection fraction altered, stored or valvular heart disease)

Secondary outcomes

  1. Prevalence

    Time frame: 3 years

    Define the prevalence of different forms of active or passive HTPcap

  2. Phenotype

    Time frame: 3 years

    Define the phenotypic characteristics of patients with reactive or passive HTPcap in heart failure

Sponsors and collaborators

Lead sponsor

French Cardiology Society

Other

Collaborators

  • CHRU Lille, Dr Nicolas LAMBLIN

Registry information

Official study title

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

Acronym: PH-HF

Important dates

Study start
2012
Primary completion
2018
Study completion
2020
First posted
Mar 6, 2012
Registry last updated
Sep 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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