Effects of Physical Training on Vascular Function as a Therapeutic Target in Pulmonary Hypertension

Study Purpose

The role of physical training in the treatment of pulmonary arterial hypertension (PAH) is controversial. The aim of the project is to evaluate the effect of physical training on markers of endothelial function and integrity and to identify those biomarkers associated with a better therapeutic response in patients with PAH and in an experimental model of pulmonary hypertension. Methodology: 1) Study in humans: sample size will be 50 patients with PAH. Responders and non-responders will be identified for a 12-week resistance training program. Before and after the physical training program, endothelial microparticles and circulating vascular progenitor cells, and metabolomic and mitochondrial function parameters in circulating endothelial cells will be analyzed. Patients will be identified in whom a more favorable response to the training program is obtained. Additionally, investigators will evaluate the relationship between this response and the biomarkers both at baseline and their change with the training program. 2) Study in a murine experimental model: investigators will study mice with pulmonary hypertension induced by the administration of Semaxanib (SU5416) and exposure to hypoxia for 3 weeks and control mice. Half of them will exercise on a treadmill for 3 weeks. At the end of the program the right ventricular pressure will be measured and the animals will be sacrificed. Morphometric studies in pulmonary and cardiac tissue, pulmonary endothelial function and metabolomic parameters in cardiac and skeletal muscle will be performed. Differences in these variables between the different experimental groups will be analyzed.

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 - 99 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Age over 18 years.

- Functional class of New York Heart Association (NYHA) II-III.

- Diagnosis of pulmonary hypertension (PH) by right heart catheterization, as follows: - Mean pulmonary arterial pressure (mPAP) >=25 mmHg.

- Pulmonary vascular resistance (PVR) ≥240 din / s / cm5.

- Pulmonary interlock pressure (PCWP) ≤15 mmHg.

- Patients with optimized PAH treatment, including intensified treatment with diuretics and who have remained stable for at least 2 months before entering the study (changes in medical treatment are not expected during the entire 12-week study period) - Be able to understand and be willing to sign the informed consent form.

Exclusion Criteria:

- Other type of PH (groups 2, 3, 4 or 5) - Pregnant women.

- Disability to exercise on a cycle ergometer or walk.

- Acute infection or fever.

- Any change in the treatment of the disease in the last 2 months.

- Acute ischemic heart disease, unstable angina pectoris, exercise-induced ventricular arrhythmias, decompensated heart failure.

- History or suspicion of inability to cooperate adequately in the study

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.	NCT03550729
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.	Hospital Clinic of Barcelona
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	Active, not recruiting
Countries	Spain
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Pulmonary Arterial Hypertension

Arms & Interventions

Arms

Experimental: Training

12-weeks of supervised endurance training program.

Interventions

Behavioral: - Endurance training

Endurance training 3 times per week during 3 months using interval training above 70% of load peak reached in the incremental exercise test. The duration of the sessions will be adapted individually to each patient (approximately 60 minutes).

Contact a Trial Team

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International Sites

Hospital Clínic, Barcelona, Spain

Status

Address

Hospital Clínic

Barcelona, , 08036

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