- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03550729
Effects of Physical Training on Vascular Function as a Therapeutic Target in Pulmonary Hypertension
April 19, 2024 updated by: Isabel Blanco, Hospital Clinic of Barcelona
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Isabel Blanco, MD, PhD
- Phone Number: 3443 +932275540
- Email: iblanco2@clinic.cat
Study Locations
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-
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Barcelona, Spain, 08036
- Hospital Clínic
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 99 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Training
12-weeks of supervised endurance training program.
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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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Endurance time
Time Frame: Baseline - 12 weeks
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Baseline - 12 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2018
Primary Completion (Estimated)
May 1, 2024
Study Completion (Estimated)
December 1, 2024
Study Registration Dates
First Submitted
May 25, 2018
First Submitted That Met QC Criteria
June 7, 2018
First Posted (Actual)
June 8, 2018
Study Record Updates
Last Update Posted (Actual)
April 22, 2024
Last Update Submitted That Met QC Criteria
April 19, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TrainHAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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