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Responsiveness of Exercise Tests in Pulmonary Arterial Hypertension

NCT ID: NCT01391104

Last Updated: 2012-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2011-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Pulmonary Arterial Hypertension

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Sildenafil

Intervention Type 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.

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.

Group Type PLACEBO_COMPARATOR

Sugar Pill

Intervention Type 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.

Interventions

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Sildenafil

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.

Intervention Type DRUG

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 Type DRUG

Other Intervention Names

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Revatio Viagra

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Laval University

OTHER

Sponsor Role lead

Responsible Party

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Vincent Mainguy

Doctorant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Steeve Provencher, MD, M.Sc.

Role: PRINCIPAL_INVESTIGATOR

Laval University

Locations

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

Québec, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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RESPONS PAH

Identifier Type: -

Identifier Source: org_study_id