To evaluate the effect of diuretics on volumes and function of the right heart in pulmonary hypertension patients.
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
Volumes: Right atrial end reservoir volume, right atrial volume at end active
emptying, right atrial volume at end passive emptying, right ventricular end
diastolic volume (RVEDV) (ml), right ventricular end systolic volume (RVESV)
(ml)
Function: Right atrial reservoir volume, right atrial passive emptying volume,
right atrial active emptying volume, right ventricular ejection fraction (RVEF)
(%)
Contractility: right atrial and right ventricular strain, NT-pro BNP levels
Secondary outcome
Other study parameters: bodyweight, 6-minute walking distance, potassium,
sodium, creatinine, stroke volume, flow
Background summary
Patients diagnosed with pulmonary arterial hypertension (PAH) and / or chronic
thrombo embolic pulmonary hypertension (CTEPH) with signs of congestive heart
failure are treated with diuretics to reduce fluid overload. Clinical
experience shows clear symptomatic benefits of this therapy in fluid overloaded
patients. Physiological effects of diuretic treatment on the right ventricle
(RV) and right atrium (RA) of patients diagnosed with PAH or CTEPH have not
been studied before. Therefore, in this study we will investigate the
physiological effects of diuretics on right ventricular and right atrial
volumes, function and contractility.
Study objective
To evaluate the effect of diuretics on volumes and function of the right heart
in pulmonary hypertension patients.
Study design
intervention study
Intervention
The usual dosage diuretics as prescribed by the medical specialist will be
temporarily withdrawn for one week.
Study burden and risks
The burden of the patient exists of two extra visits to the hospital with an
MRI scan, 6-minute walking distance test, venous puncture (6 ml), and body
weightning. This will take a maximum of two visits of two hours. When patients
have already performed measurements as routine follow-up assessment, all
measurements will be performed one extra time.
Diuretic withdrawal for a one-week period can be safe in clinically stable PH
patients. Diuretic withdrawal is expected to increase circulating blood volume.
This can result in a right ventricular (RV) volume overload, leading to mild
clinical deterioration as a consequence of RV dysfunction. Patients can
experience fluid congestions as ankle edema, ascites and an increase in body
weight. This mild signs are fully reversible by using diuretics as previously
prescribed by their medical specialist. Risks for a cardiovascular event are
negligible because solely clinically stable patients will be included without
other comorbidities as systemic hypertension or renal failure. In addition,
diuretics are only prescribed by a medical specialist to reduce secondary
effects of right heart failure (fluid congestion). Therefore, it is expected
that the hypothesized increase in preload en wall tension will solely have
fluid congestion as a clinical consequence. There will be no left-sided
decompensation. Therefore, fluid will not congest in the lungs and thus shall
not result in shortness of breath or decreased exercise tolerance.
MRI scans are performed routinely in the VU University Medical Center. Patients
have to fill in an MRI contra-indication questionnaire prior to performing an
MRI. Patients with MRI contra-indications as claustrophobia or implanted
cardiac device, pacemaker or cochlear implant will be excluded from this study.
Patients can experience discomfort as a result of the MRI scan time of one hour.
No discomfort or risks are associated with a six-minute-walking test.
Patients can experience pain during a venous puncture. No risks are associated
with venous puncture.
De Boelelaan 1117
Àmsterdam 1081HV
NL
De Boelelaan 1117
Àmsterdam 1081HV
NL
Listed location countries
Age
Inclusion criteria
- Diagnosed with idiopathic PAH, hereditary PAH, drug- and toxins induced PAH
or CTEPH,
according to ESC/ERS pulmonary hypertension guidelines
- Minimal dosage of 40mg furosemide or 1mg bumetanide a day
- NYHA classification II
- Age >=18 and <=80 years
- Able to understand and willing to sign the Informed Consent Form
Exclusion criteria
- Pregnant subjects
- Inability to provide informed consent
- Change in PAH specific therapy within 3 months before diuretic withdrawal
- Change in (dose of) any other medication
- Hospitalized for acute decompensation within one year before diuretic
withdrawal
- 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
- 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 | NL81354.029.22 |