Cardiopulmonary Interactions in Patients With Heart Failure

Withdrawn

• Conditions: Heart Failure; Heart Failure With Reduced Ejection Fraction; Heart Failure With Normal Ejection Fraction; Pulmonary Hypertension

• Registration Number: NCT03317314
• Lead Sponsor: Hannover Medical School

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.

Study Timeline

• Study Start: 2017-07-01
• Study First Submitted: 2017-07-05
• Study First Submitted QC: 2017-10-19
• Study First Posted: 2017-10-23
• Primary Completion: 2017-12-31
• Study Completion: 2017-12-31
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-08
• Last Update Posted: 2022-05-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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
Risk factors for a low DLCO	Baseline, Phone visit every 6 months up to 36 months	Obtain risk factors for a low DLCO
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
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

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Hannover MS; 🇩🇪 Hannover, Lower Saxony, Germany