ClinicalTrials.gg
RecruitingNCT01397110Updated Jul 14, 2022

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

An interventional study of respiratory and exercise therapy in Pulmonary Arterial Hypertension and Eisenmenger Syndrome, sponsored by Heidelberg University. Recruiting at 1 site in Germany. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-07-14.

Sponsored by Heidelberg University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by Dec 2025, 11 months ago, but the record still lists the study as recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Pulmonary Arterial Hypertension
  • Eisenmenger Syndrome
03

In context

Pulmonary Arterial Hypertension

699 studies on the registry are indexed under Pulmonary Arterial Hypertension; 140 are open to participants now.

This study's planned enrollment of 50 is above the median of 40 across 477 interventional studies indexed under Pulmonary Arterial Hypertension.

Browse Pulmonary Arterial Hypertension studies →

Lead sponsor

Heidelberg University is the lead sponsor of 287 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 \<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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

FEV1

From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (estimated)

Study 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.

    Other: respiratory and exercise therapy

  • 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

  • Otherrespiratory and exercise therapy

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

06

What researchers measure

Primary outcomes

  1. Changes in the maximum 6-minute walk distance (6MGT)

    Time frame: up to 15 weeks

  2. Changes in quality of life

    Time frame: up to 15 weeks

Secondary outcomes

  1. Changes in hemodynamics

    1. Changes in maximum oxygen uptake 2. Changes in exercise capacity: 6-minute walk distance, Recumbent Bike (Watts), respiratory economy (EQO2, EQCO2) 3. Improved condition(NYHA class, Borg scale) 4. Changes in Magnetic resonance tomography and echocardiographic parameters of right and left ventricle: size and pump function. 5. Change of laboratory parameters, which are markers of right heart failure as NTproBNP, interleukins

    Time frame: up to 15 weeks

07

Study locations

1 of 1 sites recruiting
  • : Center for pulmonary Hypertension, Thoraxclinic Heidelberg
    Heidelberg, 69126, Germany
    Recruiting
    • Ekkehard Gruenig, MD · Principal investigator
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2012, a primary completion of Dec 2025 and a completion of Dec 2025. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 13, 2011
First posted
Jul 19, 2011
Start
Jan 2012
Primary completionEst.
Dec 2025
CompletionEst.
Dec 2025
Last update
Jul 14, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 14, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01397110
Responsible party
Prof. Dr. med. Ekkehard Gruenig (Prof. Dr. med. Ekkehard Grünig, Heidelberg University) — Principal investigator
First posted
Jul 19, 2011
Start date
Jan 2012
Primary completion
Dec 2025 (estimated)
Completion
Dec 2025 (estimated)
Last update
Jul 14, 2022

Study contacts

Ekkehard Gruenig, MD
Contact
ekkehard.gruenig@med.uni-heidelberg.de
+49 6221 396 8053
Ekkehard Gruenig, MD
study chair · Center for pulmonary hypertension, Thoraxclinic Heidelberg

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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