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Responsiveness of Exercise Tests in Pulmonary Arterial Hypertension (RESPONS)

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ClinicalTrials.gov Identifier: NCT01391104
Recruitment Status : Completed
First Posted : July 11, 2011
Last Update Posted : October 4, 2012
Sponsor:
Information provided by (Responsible Party):
Vincent Mainguy, Laval University

July 7, 2011
July 11, 2011
October 4, 2012
April 2009
November 2011   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01391104 on ClinicalTrials.gov Archive Site
  • To assess the efficacy of a combination therapy in pulmonary arterial hypertension (PAH). [ Time Frame: 1 month ]
    Sildenafil will be added to the baseline therapy for one month (20mg tid). The efficacy of this combined therapy will be assessed by three different exercise tests and by a quality of life questionnaire.
  • To measure the physiological parameters induced by five different exercise tests in pulmonary arterial hypertension (PAH) [ Time Frame: 2 weeks ]
    Within one week, PAH patients will performed five different exercise tests. During each test, a portable telemetric system (Oxycon, Jaegger, Germany) will be used to assess the respiratory cardiovascular adaptations. Symptoms of leg fatigue and dyspnea will be assessed using the Borg scale. Quadriceps fatigability will be assessed by volitional and non-volitional (twitch force, TWq) measurements of the quadriceps strength before and immediately after each test (Magstim Co. Ltd., Whitland, Dyfed, Wales, UK).
  • To assess the efficacy of a combination therapy in pulmonary arterial hypertension (PAH). [ Time Frame: 1 month ]
    Sildenafil will be added to the baseline therapy for one month (20mg tid). The efficacy of this combined therapy will be assessed by three different exercise tests and by a quality of life questionnaire.
  • To measure the physiological parameters induced by five different exercise tests in pulmonary arterial hypertension (PAH) [ Time Frame: 1 week ]
    Within one week, PAH patients will performed five different exercise tests. During each test, a portable telemetric system (Oxycon, Jaegger, Germany) will be used to assess the respiratory cardiovascular adaptations. Symptoms of leg fatigue and dyspnea will be assessed using the Borg scale. Quadriceps fatigability will be assessed by volitional and non-volitional (twitch force, TWq) measurements of the quadriceps strength before and immediately after each test (Magstim Co. Ltd., Whitland, Dyfed, Wales, UK).
Not Provided
Not Provided
 
Responsiveness of Exercise Tests in Pulmonary Arterial Hypertension
Reproducibility and Responsiveness of Exercise Tests in Pulmonary Arterial Hypertension
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.
Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Pulmonary Arterial Hypertension
  • Drug: 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.
    Other Names:
    • Revatio
    • Viagra
  • 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.
  • Experimental: 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: Drug: Sildenafil
  • Placebo Comparator: 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: Drug: Sugar Pill
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
21
November 2011
November 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT01391104
RESPONS PAH
Yes
Not Provided
Not Provided
Vincent Mainguy, Laval University
Laval University
Not Provided
Principal Investigator: Steeve Provencher, MD, M.Sc. Laval University
Laval University
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP