Cardiopulmonary Interactions in Patients With Heart Failure

NCT ID: NCT03317314

Last Updated: 2022-05-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-01

Study Completion Date

2017-12-31

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.

Conditions

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

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Lung Biopsy during LVAD Implantation

Lung Biopsy during LVAD Implantation

Intervention Type DIAGNOSTIC_TEST

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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hannover Medical School

OTHER

Sponsor Role lead

Responsible Party

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Karen Olsson, PD Dr.

PD Dr. med. Karen Olsson

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Karen M Olsson, PD Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Hannover MS

Locations

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Hannover MS

Hanover, Lower Saxony, Germany

Site Status

Countries

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Germany

References

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Hoeper MM, Meyer K, Rademacher J, Fuge J, Welte T, Olsson KM. Diffusion Capacity and Mortality in Patients With Pulmonary Hypertension Due to Heart Failure With Preserved Ejection Fraction. JACC Heart Fail. 2016 Jun;4(6):441-9. doi: 10.1016/j.jchf.2015.12.016. Epub 2016 Feb 10.

Reference Type BACKGROUND
PMID: 26874383 (View on PubMed)

Other Identifiers

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Nr. 7155

Identifier Type: -

Identifier Source: org_study_id

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