Observatory: Search for Prognostic Factors of Pulmonary Hypertension Post-capillary in Heart Failure (PH-HF)
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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 |
|---|
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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. |
- 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)
- 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 |
|---|
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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.
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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 |
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.
Contacts and Locations| Contact: Tibaud DAMY | 33(0)144907028 | edrouet@cardio-sfc.org |
| Contact: Genevieve Mulak | 33(0)143223333 | edrouet@cardio-sfc.org |
| 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 | |
| Principal Investigator: | Thibaud DAMY | AP-HP |
More Information
Publications:
| 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: | January 24, 2013 |
| Health Authority: | France: The Commission nationale de l’informatique et des libertés |
Keywords provided by French Cardiology Society:
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Observatory Heart failure Post-capillary pulmonary hypertension HTPcap |
Additional relevant MeSH terms:
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Heart Failure Hypertension Hypertension, Pulmonary Heart Diseases |
Cardiovascular Diseases Vascular Diseases Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 23, 2013