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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.
Verified January 2013 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: January 24, 2013
Last verified: January 2013
History of Changes

February 29, 2012
January 24, 2013
February 2012
December 2016   (final data collection date for primary outcome measure)
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)
Same as current
Complete list of historical versions of study NCT01545180 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Observatory: Search for Prognostic Factors of Pulmonary Hypertension Post-capillary in Heart Failure
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.

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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
  • 3 tubes of 6 blood for analysis of biomarkers
  • 2 tubes of 6 mL blood for DNA analysis
Non-Probability Sample

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.
  • Heart Failure
  • Post-capillary Pulmonary Hypertension
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
520
June 2017
December 2016   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Tibaud DAMY 33(0)144907028 edrouet@cardio-sfc.org
Contact: Genevieve Mulak 33(0)143223333 edrouet@cardio-sfc.org
France
 
NCT01545180
11415
No
Thibaud Damy, French Cardiology Society
French Cardiology Society
CHRU Lille, Dr Nicolas LAMBLIN
Principal Investigator: Thibaud DAMY AP-HP
French Cardiology Society
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP