Effect of Exercise and Respiratory Therapy on Right Ventricular Function in Severe Pulmonary Hypertension
Study Purpose
Chronic pulmonary hypertension (PH) is associated with impaired exercise capacity, quality of life and right ventricular function.The disease is characterized by an increase of pulmonary vascular resistance and pulmonary arterial pressure, leading to right heart insufficiency. In later stages of the disease, the right heart is not able to further increase right ventricular contractility (cardiac index) during exercise. Within the last decade, new disease-targeted medical therapies have been approved for treatment of pulmonary arterial hypertension (PAH). Sequential and upfront combinations of these agents have shown to further improve symptoms, 6-minute walking distance (6-MWD) and hemodynamics in PAH patients. Previous training studies have suggested that exercise training as add-on to medical treatment is highly effective improving exercise capacity, quality of life and symptoms. Prospective studies with a 24±12 months follow-up period suggested that exercise training may also improve the rate of clinical worsening events as the need for hospitalization, additional PH-medication, lung-transplantation and death. There is also first data that exercise training may have a positive impact on the right ventricular function. This randomised controlled study aims to assess whether exercise training
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. |
Interventional |
Eligible Ages | 18 Years and Over |
Gender | All |
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. |
NCT04224012 |
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. |
N/A |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Heidelberg University |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
N/A |
Principal Investigator Affiliation | N/A |
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. |
Pulmonary Hypertension |
Contact a Trial Team
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