The primary objective of the study is to evaluate the effect of diuretics on right ventricular function and volume properties in patients with symptomatic right heart failure and PH.
ID
Source
Brief title
Condition
- Cardiac disorders, signs and symptoms NEC
- Pulmonary vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Change in stroke volume (SV) , Change in right ventricular ejection fraction
(RVEF) (%), Change in right ventricular end diastolic volume (RVEDV) (ml),
Change in right ventricular end systolic volume (RVESV) (ml), Change in right
atrial pressure (RAP),volume, Change in right ventricular strain.
Secondary outcome
nvt
Background summary
Patients with pulmonary arterial hypertension (PAH) and/or chronic
thromboembolic pulmonary hypertension (CTEPH) with signs of congestive right
heart failure are treated with loop diuretics in order to reduce fluid
overload. Clinical experience shows clear symptomatic benefit of this therapy
in fluid overloaded patients. However the physiological effects of diuretic
treatment on the right ventricle (RV) of patients with PAH have not been
studied before. Therefore, in this study we aim to investigate the
physiological effects of loop diuretics on the right ventricular volumes,
contractility and strain.
Study objective
The primary objective of the study is to evaluate the effect of diuretics on
right ventricular function and volume properties in patients with symptomatic
right heart failure and PH.
Study design
observational prospective cohort study
In order to measure RV volumes and functioncontractility (right ventricular
ejection fraction, RVEF) cardiac magnetic resonance imaging (CMR) and
echocardiogram will be performed before and after four weeks of treatment with
an enhanced dose of loop diuretics. RV wall stress will be measured by strain
measurements with CMR and by serum levels of nt-probnp NT-pro BNP.
Study burden and risks
The burden for the patient exists of one extra visit to the hospital and 1
extra MRI. There is no associated risk with participation.
De Boelelaan 1117
Amsterdam 1081HV
NL
De Boelelaan 1117
Amsterdam 1081HV
NL
Listed location countries
Age
Inclusion criteria
- Diagnosis of idiopathic PAH, hereditary PAH, drug- and toxins induced PAH or chronic thrombo-embolic PH (CTEPH), according to ESC/ERS pulmonary hypertension guidelines (15)
- Symptoms of decompensated right heart failure (ankle edema, ascites, weight gain) based on the assessment and the evaluation of the pulmonologist for which an up-titration of the diuretics is indicated
- Age >=18 and <=80 years
- Able to understand and willing to sign the Informed Consent Form
Exclusion criteria
- Pregnant subjects
- Claustrophobia
- Inability to provide informed consent
- Change in PAH specific therapy during or the 3 months before the up-titration of diuretics
- Change in (dose) of any other medication.
- One or more of the following co-morbidities:, uncontrolled systemic hypertension (>140/90 mmHg) , renal failure (eGFR <30), recent diagnosis of pulmonary embolism (within 6 months).
- Contraindication for CMR imaging:
o Claustrophobia
o Implanted cardiac defibrillator or pacemaker
o Cochlear implant
o Others
- PH of any cause other than permitted in the entry criteria
- Known history of noncompliance considering therapies
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 | NL62222.029.17 |