Responsiveness of Exercise Tests in Pulmonary Arterial Hypertension

NCT01391104 | Completed DMC

• 1 other identifier: RESPONS PAH
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Arterial Hypertension

Keywords

Pulmonary Hypertension; Pulmonary Arterial Hypertension; Exercise; Six-minute walk test; sildenafil

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  3 months

Secondary Outcomes (2)

• 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

Study Arms (2)

Sildenalfil

EXPERIMENTAL

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.

Drug: Sildenafil

Sugar Pill

PLACEBO COMPARATOR

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.

Drug: Sugar Pill

Interventions

Sildenafil DRUG

Sildenafil citrate is a phosphodiesterase type-5 inhibitor. 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.

Also known as: Revatio, Viagra

Sildenalfil

Sugar Pill DRUG

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.

Sugar Pill

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Laval University: lead

Study Sites (1)

Centre de recherche de l'Institut universitaire de cardiologie et de pneumologie de Québec (CRIUCPQ)

Québec, Quebec, G1V 4G5, Canada

Location

MeSH Terms

Conditions

Pulmonary Arterial Hypertension; Hypertension, Pulmonary; Motor Activity

Interventions

Sildenafil Citrate; Sugars

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Behavior

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Carbohydrates

Study Officials

• Steeve Provencher, MD, M.Sc.

  Laval University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctorant

Study Record Dates

• First Submitted: July 7, 2011
• First Posted: July 11, 2011
• Study Start: April 1, 2009
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: October 4, 2012

Record last verified: 2012-10

Locations

CA (1)