Respiratory and Physical Therapy in Patients With Associated Pulmonary Arterial Hypertension (APAH) With Congenital Heart Defects

Study Purpose

The purpose of this study is to investigate the influence of physical training on exercise capacity, quality of life, functional class, oxygen consumption and right ventricular function in patients with severe associated pulmonary arterial hypertension (APAH) as part of a congenital heart defect with / without Eisenmenger's Syndrome

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 80 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - signed consent form.
  • - men and women> 18 years <80 years.
  • - APAH with congenital heart defects with / without Eisenmenger syndrome (WHO functional class II-IV), invasively diagnosed by right heart and left heart catheterization: mean pulmonary arterial pressure (mPAP) ≥ 25 mmHg, with targeted PAH medication for at least two months stable before study inclusion (exception: compensated WHO class II without vasodilating drug therapy)

    Exclusion Criteria:

    - Pregnancy or lactation.
  • - Change in medication during the last 2 months.
  • - severe walking disturbance.
  • - uncertain diagnoses.
  • - No previous invasively confirmation of PH.
  • - acute diseases, infections, fever.
  • - Serious lung disease with FEV1 <50% or TLC <70% of target.
- Further exclusion criteria are the following diseases: active myocarditis, unstable angina pectoris, exercise-induced ventricular arrhythmias, recurrent syncope within 4 weeks before study entry

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT01397110
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Heidelberg University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Ekkehard Gruenig, MD
Principal Investigator Affiliation Center for pulmonary hypertension, Thoraxclinic Heidelberg
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Germany
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Pulmonary Arterial Hypertension, Eisenmenger Syndrome
Arms & Interventions

Arms

Active Comparator: Respiratory and exercise therapy

Randomized, prospective, controlled, blinded study of three-week inpatient rehabilitation and subsequent continuing of the training at home for 12 weeks. The control group received conventional rehabilitation without a specific training program. After 15 weeks training is also offered to patients in the control group.

No Intervention: Control group without exercise training

patients of the control group continue their sedentary lifestyle without given advice for exercise training. The time before start of rehabilitation (three months) serves as control group. Afterwards patients take part in the training program as well.

Interventions

Other: - respiratory and exercise therapy

Conventional therapy with specific respiratory and physical therapy plus mental walking training

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Heidelberg, Germany

Status

Recruiting

Address

: Center for pulmonary Hypertension, Thoraxclinic Heidelberg

Heidelberg, , 69126

For more information, please contact PHA at Research@PHAssociation.org and refer to the terms of service below.

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