Cardiopulmonary Interactions in Patients With Heart Failure

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	40 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03317314
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Hannover Medical School
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Karen M Olsson, PD Dr. med.
Principal Investigator Affiliation	Hannover MS
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Germany
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Heart Failure, Pulmonary Hypertension, Heart Failure With Reduced Ejection Fraction, Heart Failure With Normal Ejection Fraction

Additional Details

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.

Contact a Trial Team

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