The primary aim of this observational study is to determine the occurrence of (exercise-induced) pulmonary hypertension (sPAP > 40 mmHg) in IIP patients with an elevated V*E/V*CO2 at AT (> 34) assessed during CPET. And, secondly to study the…
ID
Source
Brief title
Condition
- Heart failures
- Pulmonary vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameters are systolic pulmonary arterial pressure and ventilatory
equivalents for CO2 at anaerobic threshold
Secondary outcome
CPET parameters; peak oxygen uptake (peak V*O2), V*O2 at the anaerobic
threshold, ventilatory reserve, the ventilatory equivalent for O2 and CO2 (V*E/
V*O2 and V*E/V*CO2) at peak exercise, and oxygen-pulse (O2-pulse (V*O2/HR)).
Baseline spirometry and diffusion capacity. Biomarkers of (left and right)
ventricular strain (NT-proBNP).
Background summary
The development of PH at rest in patients with idiopathic interstitial
pneumonias (IIP) has a negative impact on survival. Cardiopulmonary exercise
test (CPET) parameters, in particular V*E/V*CO2 at AT, may be of use to
identify patients with (exercise-induced) PH. Previously, V*E/V*CO2 at AT was
shown to correlate with PH at rest; and, to be an independent predictor of
mortality. In contrast, PH at rest did not predict survival in this group. It
might be hypothesised that V*E/V*CO2 at AT detects PH at exercise even before
it manifests itself at rest; and, can therefore be used as a early,
non-invasive prognosticator in IIP patients.
Study objective
The primary aim of this observational study is to determine the occurrence of
(exercise-induced) pulmonary hypertension (sPAP > 40 mmHg) in IIP patients with
an elevated V*E/V*CO2 at AT (> 34) assessed during CPET. And, secondly to
study the predictive value of other CPET parameters indicative of a pulmonary
vascular limitation for the presence (exercise induced) pulmonary hypertension.
Study design
Observational study
Study burden and risks
Patients included in the study participate in investigations as part of routine
clinical practice. As part of the study, an additional visit to the hospital
for echocardiography during exercise is necessary. During exercise venous blood
samples will be taken twice according to study protocol. The risks and physical
discomforts of the investigations are to the same extend as described for
exercise testing as part of routine clinical practice.
Oosterpark 9
Amsterdam 1091 AC
NL
Oosterpark 9
Amsterdam 1091 AC
NL
Listed location countries
Age
Inclusion criteria
-IIP patients, defined as IPF or fibrotic NSIP will be included in the study. Diagnosis ill be made according to the ATS/ERS guidelines (1, 23).
- Informed consent
- > 18 years of age
- Male and female
Exclusion criteria
-Occupational or environmental cause for the pulmonary fibrosis.
-Age <= 18 years of age
-Pregnancy
-Patients not able to perform a cycling test
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL37917.100.12 |
| Other | NL37917.100.12 |