Cardiopulmonary Interactions in Patients With Heart Failure

Study Overview
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Brief Summary
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This study aims to evaluate cardiopulmonary interactions in patients with heat failure

Detailed Description
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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.

Official Title
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Cardiopulmonary Interactions in Patients With Heart Failure (Kardio-pulmonale Interaktionen Bei Patienten Mit Linksherzerkrankungen)

Conditions
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Heart Failure, Pulmonary Hypertension, Heart Failure With Reduced Ejection Fraction, Heart Failure With Normal Ejection Fraction

Intervention / Treatment
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* Diagnostic Test: Lung Biopsy during LVAD Implantation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Lung Biopsy during LVAD Implantation|Lung Biopsy during LVAD Implantation|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary Function in Heart failure | Pulmonary Function including DLCO (diffusion capacity of the lungs for carbon monoxide) | Every Year up tp 36 months | 
| Relationship DLCO and hemodynamics | To study the relationship between DLCO, KCO (diffusion capacity per unit alveolar volume) and hemodynamics in patients with heart failure | Every year up to 36 months, hemodynamics are not mandatory | 
| Risk factors for a low DLCO | Obtain risk factors for a low DLCO | Baseline, Phone visit every 6 months up to 36 months | 
| Impact of LVAD (left ventricular assist device) implantation on lung function | Impact of LVAD implantation on lung function | LVAD implantation, 6 months after LVAD implantation, LVAD explantation, 6 months after LVAD explantation, and yearly up to 36 months | 
| Predictors of survival and heart-failure related hospitalisations | Predictors of survival and heart-failure related hospitalisations | Baseline, 1 year, Phone visit every 6 months, up to 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morphometric data of the pulmonary capillary bed | 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. | 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. |