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

Sponsor

Hospital Clinic of Barcelona (Other)

Overall Status

Unknown status

CT.gov ID

NCT03550729

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

N/A

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 :

Jul 1, 2018

Anticipated Primary Completion Date :

Aug 1, 2019

Anticipated Study Completion Date :

Dec 1, 2020

Arms and Interventions

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).

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).

Outcome Measures

Primary Outcome Measures

Endurance time [Baseline - 12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Clínic	Barcelona		Spain	08036

Sponsors and Collaborators

Hospital Clinic of Barcelona

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Isabel Blanco, Senior specialist in Pneumology, Hospital Clinic of Barcelona

ClinicalTrials.gov Identifier:

NCT03550729

Other Study ID Numbers:

TrainHAP

First Posted:

Jun 8, 2018

Last Update Posted:

Aug 10, 2018

Last Verified:

Aug 1, 2018

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Isabel Blanco, Senior specialist in Pneumology, Hospital Clinic of Barcelona

Exercise training

Biomarkers

Additional relevant MeSH terms:

Hypertension, Pulmonary

Pulmonary Arterial Hypertension

Hypertension

Study Results

No Results Posted as of Aug 10, 2018