Reproducibility and Responsiveness of Exercise Tests in Pulmonary Arterial Hypertension
Overview
- Phase
- Not Applicable
- Intervention
- Sildenafil
- Conditions
- Pulmonary Arterial Hypertension
- Sponsor
- Laval University
- Enrollment
- 22
- Locations
- 1
- Primary Endpoint
- To compare the reproducibility and the responsiveness of the 6MWT, the endurance shuttle walk test (ESWT) and the cycle endurance test (CET) following pharmacological therapy in PAH.
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
Pulmonary arterial hypertension (PAH) is characterized by the progressive increase in pulmonary vascular resistance leading to shortness of breath and exercise intolerance. Exercise capacity has been used as the primary endpoint in most recent randomized controlled trials evaluating PAH-specific therapies as it correlates with functional class and survival in PAH. Exercise test is commonly assessed by the six-minute walk test (6MWT). However, there is commonly some discrepancy between significant clinical improvement and minor changes (generally <10% from baseline) in 6WMT following therapy. Because important clinical decisions are based on patients' functional capacity, a reproducible and sensitive exercise test is needed in PAH. The aim of this study was to compare the reproducibility and the responsiveness of the 6MWT, the endurance shuttle walk test (ESWT) and the cycle endurance test (CET) following pharmacological therapy in this disease.
Investigators
Vincent Mainguy
Doctorant
Laval University
Eligibility Criteria
Inclusion Criteria
- •WHO functional class II or III
- •Idiopathic PAH, familial PAH, or associated PAH due to connective tissue disease patients
- •Mean pulmonary artery pressure ≥25 mmHg at rest
- •Pulmonary capillary wedge pressure ≤15 mmHg
Exclusion Criteria
- •Prior use of phosphodiesterase type-5 inhibitors
- •Unstable clinical condition over the last 4 months
- •Recent syncope
- •WHO functional class IV
- •Left ventricular ejection fraction \<40%
- •Restrictive or obstructive lung disease
- •Intrinsic musculoskeletal abnormality precluding exercise testing
- •Patients with a pacemaker
- •Treatment with systemic corticosteroids
Arms & Interventions
Sildenalfil
Patients will be assigned to sildenafil (20 mg tid) or placebo per os for 28 days in a randomized, double-blind manner. After a four-week wash-out period, patients will then be crossed over to the alternate therapy for the next 28 days.
Intervention: Sildenafil
Sugar Pill
Patients will be assigned to sildenafil (20 mg tid) or placebo per os for 28 days in a randomized, double-blind manner. After a four-week wash-out period, patients will then be crossed over to the alternate therapy for the next 28 days.
Intervention: Sugar Pill
Outcomes
Primary Outcomes
To compare the reproducibility and the responsiveness of the 6MWT, the endurance shuttle walk test (ESWT) and the cycle endurance test (CET) following pharmacological therapy in PAH.
Time Frame: 3 months
After completing the 6MWT, the ESWT and the CET in a randomized order, patients will then be randomized to sildenafil (20mg tid) or placebo in a double-blind manner for 28 days. The three exercise tests will then be repeated. After a four-week of wash-out period, patients will repeat the three exercise test and then be crossed over to the alternate therapy for the next 28 days. The same experiments will be repeated after this period. The reproducibility of each exercise test will be assessed following placebo. The responsiveness of each exercise test will be assessed following sildenafil.
Secondary Outcomes
- To assess the efficacy of a combination therapy in pulmonary arterial hypertension (PAH).(1 month)
- To measure the physiological parameters induced by five different exercise tests in pulmonary arterial hypertension (PAH)(2 weeks)