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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01545180
Recruitment Status : Recruiting
First Posted : March 6, 2012
Last Update Posted : November 24, 2017
CHRU Lille, Dr Nicolas LAMBLIN
Information provided by (Responsible Party):
Thibaud Damy, 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.

Condition or disease
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 Type : Observational
Estimated Enrollment : 520 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observatory: Search for Prognostic Factors of Pulmonary Hypertension Post-capillary in Heart Failure.
Study Start Date : February 2012
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

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.

Primary Outcome Measures :
  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 Outcome Measures :
  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

Biospecimen Retention:   Samples With DNA
  • 3 tubes of 6 blood for analysis of biomarkers
  • 2 tubes of 6 mL blood for DNA analysis

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01545180

Contact: Tibaud DAMY 33(0)144907028
Contact: Genevieve Mulak 33(0)143223333

Henri Mondor Hospital Recruiting
Creteil, France, 94000
Contact: Thibaud DAMY    33(0)144907028   
Contact: Geneviève Mulak    33(0)143223333   
Principal Investigator: Thibaud DAMY         
Sponsors and Collaborators
French Cardiology Society
CHRU Lille, Dr Nicolas LAMBLIN
Principal Investigator: Thibaud DAMY Assistance Publique - Hôpitaux de Paris

Dickstein K, Cohen-Solal A, Filippatos G, McMurray JJ, Ponikowski P, Poole-Wilson PA, Strömberg A, van Veldhuisen DJ, Atar D, Hoes AW, Keren A, Mebazaa A, Nieminen M, Priori SG, Swedberg K; ESC Committee for Practice Guidelines (CPG). ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure 2008: the Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2008 of the European Society of Cardiology. Developed in collaboration with the Heart Failure Association of the ESC (HFA) and endorsed by the European Society of Intensive Care Medicine (ESICM). Eur Heart J. 2008 Oct;29(19):2388-442. doi: 10.1093/eurheartj/ehn309. Epub 2008 Sep 17. Review. Erratum in: Eur Heart J. 2010 Apr;12(4):416. Dosage error in article text. Eur Heart J. 2010 Mar;31(5):624. Dosage error in article text.

Responsible Party: Thibaud Damy, Assistant Professor, French Cardiology Society Identifier: NCT01545180     History of Changes
Other Study ID Numbers: 11415
First Posted: March 6, 2012    Key Record Dates
Last Update Posted: November 24, 2017
Last Verified: November 2017

Keywords provided by Thibaud Damy, French Cardiology Society:
Heart failure
Post-capillary pulmonary hypertension

Additional relevant MeSH terms:
Heart Failure
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Heart Diseases
Lung Diseases
Respiratory Tract Diseases