Skip to content

Evaluation of inhaled medications to improve breathing during exercise in patients with Pulmonary Arterial Hypertension

Evaluation of inhalation inteventions to attenuate the abnormalities of respiratory mechanics during patient's exercise whit pulmonary arterial hypertension

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-66359j
Enrollment
Unknown
Registered
2019-09-25
Start date
2019-11-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pulmonary arterial hypertension

Interventions

Experimental group, 38 patients with pulmonary arterial hypertension, will visit at visit 1: clinical evaluation that investigates the symptoms and medications previously used, will be done by intervi
Drug
Procedure/surgery
E07.605.750
G11.427.410.698.277

Sponsors

Universidade Federal do Rio Grande do Sul
Lead Sponsor
Fundo de Incentivo à Pesquisa e Eventos (FIPE)
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients diagnosed with pulmonary arterial hypertension according to the Nice classification, 2013, confirmed by right cardiac catheterization at rest. Stable drug treatment in the last 3 months. Symptomatic, with dyspnoea. In functional class of the New York Heart Association II and III.

Exclusion criteria

Exclusion criteria: Non-HAP Pulmonary Hypertension, that is, Groups 2 to 5 will be excluded, as well as patients with other comorbidities that may cause limitation of exercise capacity. Use of prolonged home oxygen therapy. That they present FEV1VF <0.7. Be involved in regular physical activity programs in the last 3 to 6 months.

Design outcomes

Primary

MeasureTime frame
Dyspnea assessed by the Borg categorical scale during isotype (highest common time in all tests) in high intensity constant load ECT (cardiopulmonary exercise test) comparing inhaled bronchodilator, furosemide and placebo.

Secondary

MeasureTime frame
510/5000 Expected outcome 1: In isotherm and isoventilation, during high intensity constant load TECP, contrasting the 3 interventions. Improvement of parameters of respiratory mechanics: inspiratory capacity (IC); inspiratory reserve volume (VRI); final inspiratory pulmonary volume (FVII) / total lung capacity (CPT); VT / CI limitation to expiratory flow (LFE) evaluated by the percentage of overlap of the VT expiratory flow loop over the maximum flow-volume loop (flow-volume loop technique);;Expected outcome 2: Decreased pain in lower limbs (Borg categorical scale);;Expected outcome 3: Improvement in noninvasive hemodynamic variables (oxygen pulse, heart rate and HR / VO2 ratio).;Expected outcome 4: Decrease of exercise tolerance time (Tlim) during constant load ECT comparing the 3 interventions.;Expected outcome 5: In the incremental cardiopulmonary exercise test to evaluate the correlation between the variation of rest and peak of exercise of the following variables: Improvement of parameters of respiratory mechanics and variables of invasive hemodynamics (pulmonary artery pressure, pulmonary vascular resistance, cardiac output; cardiac index, systolic volume, pulmonary vascular compliance, right ventricular work index);;Expected outcome 6: Improvement of parameters of respiratory mechanics during exercise with parameters of resting pulmonary function: forced expiratory volume in the first second (FEV1); FEV1 / forced vital capacity (FVC); forced expiratory flow between 25-75% of FVC (FEF25-75%); LFE (flow-volume loop technique); pulmonary volumes measured by body plethysmography and pulmonary diffusion capacity of carbon monoxide (DLCO).

Countries

Brazil

Contacts

Public ContactElisa Schroeder

Universidade Federal do Rio Grande do Sul

elisasc.es@gmail.com+55-051-33598241

Outcome results

None listed

Source: REBEC (via WHO ICTRP)