Responsiveness of Exercise Tests in Pulmonary Arterial Hypertension (RESPONS)

Laval University

Status: Completed

Conditions: Pulmonary Arterial Hypertension

Treatments: Drug: Sugar Pill; Drug: Sildenafil

Study type: Interventional

Funder types: Other

Identifiers

NCT01391104

RESPONS PAH

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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22 participants in 2 patient groups, including a placebo group

Sildenalfil

Experimental group

Description:

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.

Treatment:

Drug: Sildenafil

Sugar Pill

Placebo Comparator group

Description:

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.

Treatment:

Drug: Sugar Pill