The Early Recognition of Pulmonary Arterial Hypertension

NCT00609349 | Completed

• 1 other identifier: 16-250 ex 04/05
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

The early detection of pulmonary arterial hypertension may help to improve prognosis of the disease. It is assumed that in the early stages of pulmonary arterial hypertension, pulmonary arterial pressure values may be normal at rest, but the remodelling of small arteries leads to stiffening resulting in increased pulmonary arterial pressure during exercise. In the present study we investigate patients with risk factors for pulmonary arterial hypertension (e.g. connective tissue disease) by combining exercise tricuspid echo doppler and cardiopulmonary exercise test to screen patients for exercise-induced pulmonary hypertension and control the results by the gold standard right heart catheterisation at rest and during exercise. We expect that using this screening method, patients with pulmonary arterial hypertension would be recognized earlier.

Conditions

Pulmonary Arterial Hypertension

Keywords

risk factors for pulmonary arterial hypertension

Outcome Measures

Primary Outcomes (1)

• pulmonary arterial pressure

  measurements with right heart catheterisation within 1 month after exercise tricuspid doppler

Secondary Outcomes (1)

• exercise capacity (peakVO2, 6 minute walk distance)

  controlled at 1 year after baseline

Study Arms (1)

connective tissue disease

OTHER

all patients suffer from a connective tissue disease representing a risk for the development of pulmonary hypertension

Device: ETED, CPET, RHC

Interventions

ETED, CPET, RHC DEVICE

exercise tricuspid echo doppler (ETED): allows the estimation of systolic pulmonary arterial pressure at exercise cardiopulmonary exercise test (CPET) allows to measures exercise capacity (peakVO2) right heart catheterisation (RHC): is the gold standard for the measurement of pulmonary arterial pressure values

connective tissue disease

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Systemic sclerosis
• SLE
• Late corrected left-right shunt
• HIV Infection
• Splenectomy over 10 years
• Haemoglobinopathy and Thrombocytosis
• Ventriculo-atrial Shunt
• Liver cirrhosis/other portal Hypertension
• Anamnestic Aminorex or PhenFen abuse
• Close relatives of patients with IPAH
• Healthy controls

You may not qualify if:

• Known PAH
• Severe lung or bronchial disease (FEV1 \<70% predicted)
• Systolic LV dysfunction (LVEF \<50%) or diastolic dysfunction (pulmonary arterial "wedge" pressure (PAWP) ≥15 mmHg)
• Valvular dysfunction \> Grad I (except of Tricuspidal- and Pulmonary insufficiency)
• Uncontrolled systemic arterial hypertension (rest \>150 mmHg systolic or 90 mmHg diastolic; exercise \>220 mmHg systolic)
• Uncontrolled ventricular arrythmia
• Uncontrolled supraventricular arrythmia
• Myocardial infarction within last 12 months
• Pulmonary embolism within last 12 months
• Significant change in therapy or larger operation within last 12 weeks
• Inability of performing exercise on cycle ergometer

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Medical University Graz, Division of Pulmonology

Graz, Styria, 8036, Austria

Location

Related Publications (2)

• Kovacs G, Maier R, Aberer E, Brodmann M, Scheidl S, Hesse C, Troester N, Salmhofer W, Stauber R, Fuerst FC, Thonhofer R, Ofner-Kopeinig P, Gruenig E, Olschewski H. Assessment of pulmonary arterial pressure during exercise in collagen vascular disease: echocardiography vs right-sided heart catheterization. Chest. 2010 Aug;138(2):270-8. doi: 10.1378/chest.09-2099. Epub 2010 Apr 23.

  PMID: 20418368 DERIVED

• Kovacs G, Maier R, Aberer E, Brodmann M, Scheidl S, Troster N, Hesse C, Salmhofer W, Graninger W, Gruenig E, Rubin LJ, Olschewski H. Borderline pulmonary arterial pressure is associated with decreased exercise capacity in scleroderma. Am J Respir Crit Care Med. 2009 Nov 1;180(9):881-6. doi: 10.1164/rccm.200904-0563OC. Epub 2009 Aug 13.

  PMID: 19679693 DERIVED

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Study Officials

• Horst Olschewski, MD

  Medical University of Graz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2008
• First Posted: February 7, 2008
• Study Start: April 1, 2006
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: January 12, 2012

Record last verified: 2012-01

Locations

AU (1)