Cardiopulmonary Interactions in Patients With Heart Failure

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03317314
• Other study ID #: Nr. 7155
• Status: Withdrawn
• Start date: July 1, 2017
• Est. completion date: December 31, 2017

Study information

• Verified date: May 2022
• Source: Hannover Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study aims to evaluate cardiopulmonary interactions in patients with heat failure

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Diagnostic Test:
• Lung Biopsy during LVAD Implantation
Lung Biopsy during LVAD Implantation

Locations

Country	Name	City	State
Germany	Hannover MS	Hannover	Lower Saxony

Sponsors (1)

Lead Sponsor	Collaborator
Hannover Medical School

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulmonary Function in Heart failure	Pulmonary Function including DLCO (diffusion capacity of the lungs for carbon monoxide)	Every Year up tp 36 months
Primary	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
Primary	Risk factors for a low DLCO	Obtain risk factors for a low DLCO	Baseline, Phone visit every 6 months up to 36 months
Primary	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
Primary	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	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.