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OpenTrials
Completed

NCT Number: NCT02579954

Cardiac Function and Exercise Capacity in Pulmonary Arterial Hypertension

Pulmonary Arterial Hypertension is characterized by a progressive increase in pulmonary vascular resistance inducing shortness of breath and exercise intolerance. We aim to correlate cardiac function (evaluated at rest by right heart catheterism and RMN) to exercise capacity (evaluated by endurance time at 75% of maximal workout), in prevalent patients with pulmonary arterial hypertension, and their evolution at three and twelve months.

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Key information

Conditions

Pulmonary Arterial Hypertension Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Besançon, Besançon, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients
  • Patients with Pulmonary Arterial Hypertension (idiopathic, heritable or due to anorexigens),
  • Prevalent cases of pulmonary artery hypertension (≥ 6 months) confirmed by right heart catheterism,
  • Stable for at least 3 months,
  • Written consent.

Exclusion criteria

  • Patients unable to proceed with six-minute walk test or CPET, or with contra-indication to exercise evaluation (syncope, low cardiac index, etc).
  • Exercise induced abnormality (evaluated during the initial CPET) precluding to further evaluation.

Treatment and study plan

Rehabilitation

Behavioral

Other names: Supervised rehabilitation

Primary outcomes

  1. Endurance time at 75% of the maximal workout (determinated during a cardiopulmonary exercise testing - CPET),

    Time frame: 12 months after the inclusion

Secondary outcomes

  1. Right ventricular ejection fraction evaluated by RMN

    Time frame: at 3 and 12 months

  2. Pulmonary haemodynamics : measurements at right heart catheterism

    Time frame: at 3 and 12 months

    cardiac index (L/min/m²)

  3. Pulmonary haemodynamics : measurements at right heart catheterism

    Time frame: at 3 and 12 months

    pressure in the right atrium (mmHg)

  4. Pulmonary haemodynamics : measurements at right heart catheterism

    Time frame: at 3 and 12 months

    pulmonary resistance (uw)

  5. Pulmonary haemodynamics : measurements at right heart catheterism

    Time frame: at 3 and 12 months

    mean pulmonary arterial pressure (mmHg)

  6. Functional class (NYHA classification)

    Time frame: at 3 and 12 months

  7. 6 minutes walking distance (m)

    Time frame: at 3 and 12 months

  8. Functional exercise capacity (oxygen consumption measurement during test)

    Time frame: at 3 and 12 months

  9. Quality of life (SF-36 scale)

    Time frame: at 3 and 12 months

  10. Time to clinical worsening (months)

    Time frame: at 3 and 12 months

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Collaborators

  • Ministry of Health, France

Registry information

Acronym: FONCE-HTAP

Important dates

Study start
2015
Primary completion
2022
Study completion
2024
First posted
Oct 20, 2015
Registry last updated
Jun 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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