Heart Failure, Heart Failure With Normal Ejection Fraction, Heart Failure With Reduced Ejection Fraction, Pulmonary Hypertension
Conditions
Brief summary
This study aims to evaluate cardiopulmonary interactions in patients with heat failure
Detailed description
Heart failure is one of the most common diseases, especially in ageing populations, affecting ≥10% of persons 70 years of age or older. There is a growing body of evidence that dyspnea in patients with heart failure is not only related to low cardiac output and pulmonary venous congestion, but also to functional and structural alterations of the lungs.Pulmonary hypertension is a well-known complication of heart failure, but recent evidence suggests that the alveolo-capillary membrane is also affected, at least in subgroups of patients with heart failure. Damage to the alveolo-capillary membrane is reflected by a low diffusion capacity of the lungs for carbon monoxide (DLCO). In this study we aim to describe the alteration of lung function and obtain morphometric data of the capillary bed of patients with heart failure.
Interventions
DIAGNOSTIC_TESTLung Biopsy during LVAD Implantation
Lung Biopsy during LVAD Implantation
Sponsors
Hannover Medical School
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Written informed consent prior to initiation of any study-mandated procedures * Male or female ≥40 years at screening * Confirmed diagnosis of HFpEF (Heart failure with preserved ejection fraction), HFmrEF (heart failure with mid range ejection fraction) or HFrEF (Heart failure with reduced ejection fraction) in New York Heart Association (NYHA) Functional Class II, III or IV
Exclusion criteria
* Significant lung disease according to the judgment of the investigator; as a rule, the total lung capacity (TLC) should be \>70% of the predicted value and the forced expiratory volume in 1 second (FEV1) should be \>60% of the predicted value * Significant co-morbidities expected to limit life expectancy to less than 2 years, according to the judgment of the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pulmonary Function in Heart failure | Every Year up tp 36 months | Pulmonary Function including DLCO (diffusion capacity of the lungs for carbon monoxide) |
| Relationship DLCO and hemodynamics | Every year up to 36 months, hemodynamics are not mandatory | To study the relationship between DLCO, KCO (diffusion capacity per unit alveolar volume) and hemodynamics in patients with heart failure |
| Risk factors for a low DLCO | Baseline, Phone visit every 6 months up to 36 months | Obtain risk factors for a low DLCO |
| Impact of LVAD (left ventricular assist device) implantation on lung function | LVAD implantation, 6 months after LVAD implantation, LVAD explantation, 6 months after LVAD explantation, and yearly up to 36 months | Impact of LVAD implantation on lung function |
| Predictors of survival and heart-failure related hospitalisations | Baseline, 1 year, Phone visit every 6 months, up to 36 months | Predictors of survival and heart-failure related hospitalisations |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Morphometric data of the pulmonary capillary bed | Biopsies are taken once during LVAD implantation, Heart transplantation or LVAD explantation if performed (variable time points) and compared with the functional assessments, in particular with DLCO and KCO up to 36 months. | 1\. To obtain morphometric data on the pulmonary microvasculature in patients with heart failure by taking open lung biopsies from patients with heart failure undergoing heart transplantation or LVAD implantation. The morphometric data will be compared with the functional assessments, in particular with DLCO and KCO. |
Countries
Germany
Outcome results
None listed