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

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ClinicalTrials.gov Identifier: NCT03550729
Recruitment Status : Recruiting
First Posted : June 8, 2018
Last Update Posted : August 10, 2018
Sponsor:
Information provided by (Responsible Party):
Isabel Blanco, Hospital Clinic of Barcelona

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pulmonary Arterial Hypertension Behavioral: Endurance training Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effects of Physical Training on Vascular Function as a Therapeutic Target in Pulmonary Hypertension
Actual Study Start Date : July 1, 2018
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : December 2020


Arm Intervention/treatment
Experimental: Training
12-weeks of supervised endurance training program.
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).




Primary Outcome Measures :
  1. Endurance time [ Time Frame: Baseline - 12 weeks ]


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03550729


Contacts
Contact: Isabel Blanco, MD, PhD +932275540 ext 3443 iblanco2@clinic.cat

Locations
Spain
Hospital Clínic Recruiting
Barcelona, Spain, 08036
Contact: Isabel Blanco, MD, PhD    +34 649539835    iblanco2@clinic.cat   
Sponsors and Collaborators
Hospital Clinic of Barcelona

Responsible Party: Isabel Blanco, Senior specialist in Pneumology, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT03550729     History of Changes
Other Study ID Numbers: TrainHAP
First Posted: June 8, 2018    Key Record Dates
Last Update Posted: August 10, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Isabel Blanco, Hospital Clinic of Barcelona:
Exercise training
Biomarkers

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases