Status:
COMPLETED
A Randomized Controlled Multicenter Trial of Exercise Training in Pulmonary Hypertension in European Countries
Lead Sponsor:
Heidelberg University
Conditions:
Pulmonary Hypertension
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Chronic pulmonary hypertension (PH) is associated with impaired exercise capacity, quality of life and right ventricular function. The disease is characterized by an increase of pulmonary vascular res...
Detailed Description
Pulmonary hypertension (PH) is defined as a mean pulmonary arterial pressure ≥25 mmHg. PH is often diagnosed at an advanced stage (WHO functional class III-IV) with a massive increase of the mean pulm...
Eligibility Criteria
Inclusion
- Female and male patients of any ethnic origin ≥ 18 years
- WHO functional class II-IV
- PH diagnosed by right heart catheter showing:
- Baseline mean pulmonary arterial pressure (mPAP) ≥ 25 mmHg
- Baseline pulmonary vascular resistance (PVR) ≥ 240 dyn x s x cm-5
- Baseline pulmonary capillary wedge pressure (PCWP) ≤ 15 mm Hg
- Patients receiving optimized conventional PH therapy including intensified treatment with diuretics and who have been stable for 2 months before entering the study
- Except for diuretics, medical treatment should not be expected to change during the entire 15-week study period
- Negative pregnancy test (β-HCG) at the start of the trial and appropriate contraception throughout the study for women with child-bearing potential
- Able to understand and willing to sign the Informed Consent Form
Exclusion
- PH of any cause other than permitted in the entry criteria, e.g. concomitantly to portal hypertension, complex congenital heart disease, reversed shunt, HIV infection, suspected pulmonary veno-occlusive disease based on pulmonary edema during a previous vasoreactivity test or on abnormal findings compatible with that diagnosis (septal lines or pulmonary edema at high resolution computer tomography), congenital or acquired valvular defects with clinically relevant myocardial function disorders not related to pulmonary hypertension or unclear diagnosis
- Pregnancy
- Patients with signs of right heart decompensation
- Walking disability
- Acute infection
- Pyrexia
- Any change in disease-targeted therapy within the last 2 months
- Any subject who is scheduled to receive an investigational drug during the course of this study
- Severe lung disease: FEV1/FVC \<0.5 and total lung capacity \< 70% of the normal value
- Active liver disease, porphyria or elevations of serum transaminases \>3 x ULN (upper limit of normal) or bilirubin \> 1.5 x ULN
- Hemoglobin concentration of less than 75 % of the lower limit of normal
- Systolic blood pressure \< 85 mmHg
- Active myocarditis, instable angina pectoris, exercise induced ventricular arrhythmias, decompensated heart failure, hypertrophic obstructive cardiomyopathy, highly impaired left ventricular function
- History or suspicion of inability to cooperate adequately. will be excluded from the study.
- Additional exclusion criteria for MRI (optional)
- Acute psychosis or other states of mind, which seem to impair patient's ability to comprehend instructions
- Patients with metal cardiac valves or other metal implants, incorporated ferromagnetic materials or MRI-incompatible active medicinal products
- Claustrophobia
Key Trial Info
Start Date :
February 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2019
Estimated Enrollment :
129 Patients enrolled
Trial Details
Trial ID
NCT03345212
Start Date
February 1 2016
End Date
December 1 2019
Last Update
December 19 2019
Active Locations (1)
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1
Centre for pulmonary hypertension of the Thoraxclinic at the University Hospital Heidelberg
Heidelberg, Germany, 69126