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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by French Cardiology Society
Sponsor:
Collaborator:
CHRU Lille, Dr Nicolas LAMBLIN
Information provided by (Responsible Party):
Thibaud Damy, French Cardiology Society
ClinicalTrials.gov Identifier:
NCT01545180
First received: February 29, 2012
Last updated: July 8, 2014
Last verified: July 2014
  Purpose

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
Heart Failure
Post-capillary Pulmonary Hypertension

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observatory: Search for Prognostic Factors of Pulmonary Hypertension Post-capillary in Heart Failure.

Resource links provided by NLM:


Further study details as provided by French Cardiology Society:

Primary Outcome Measures:
  • Prognostic [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Estimate the prognosis of different forms of HTPcap in heart failure (ejection fraction altered, stored or valvular heart disease)


Secondary Outcome Measures:
  • Prevalence [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Define the prevalence of different forms of active or passive HTPcap

  • Phenotype [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    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

Estimated Enrollment: 520
Study Start Date: February 2012
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01545180

Contacts
Contact: Tibaud DAMY 33(0)144907028 edrouet@cardio-sfc.org
Contact: Genevieve Mulak 33(0)143223333 edrouet@cardio-sfc.org

Locations
France
Henri Mondor Hospital Recruiting
Creteil, France, 94000
Contact: Thibaud DAMY    33(0)144907028    edrouet@cardio-sfc.org   
Contact: Geneviève Mulak    33(0)143223333    edrouet@cardio-sfc.org   
Principal Investigator: Thibaud DAMY         
Sponsors and Collaborators
French Cardiology Society
CHRU Lille, Dr Nicolas LAMBLIN
Investigators
Principal Investigator: Thibaud DAMY AP-HP
  More Information

Publications:
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. 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
ClinicalTrials.gov Identifier: NCT01545180     History of Changes
Other Study ID Numbers: 11415
Study First Received: February 29, 2012
Last Updated: July 8, 2014
Health Authority: France: The Commission nationale de l’informatique et des libertés

Keywords provided by French Cardiology Society:
Observatory
Heart failure
Post-capillary pulmonary hypertension
HTPcap

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

ClinicalTrials.gov processed this record on November 27, 2014