RISE-HF: Right Ventricular Contractile Reserve in HF
Study Details
Study Description
Brief Summary
Right ventricle dysfunction and pulmonary hypertension are related to a worse prognosis in patients with heart failure with reduced left ventricular ejection fraction (HFrEF) or with normal left ventricular ejection fraction (HFpEF).
There is preliminary evidence however, that the responses of the right ventricle and of the pulmonary hemodynamics to stress tests (especially physical stress) may allow to prognostically stratify these patients, as these responses may bring out latent right ventricle dysfunction or a normal contractile reserve in patients with dysfunction at rest.
In view of the different pathophysiological mechanisms of the left ventricular dysfunction in HFpEF and in HFrEF, also the response and the adaptation of the righty ventricle to stress tests may be different in these two groups of patients.
In this preliminary two groups of 20 patients with HFpEF and HFrEF will be subjected to to simple stress tests: passive leg raising and inotropic stimulus with dobutamine.
This study intends to analyze, through colorDoppler echocardiography, the behaviour of the right ventricle and the pulmonary circulation during passive leg raining and infusion of dobutamine, in a cohort of patients with HFrEF or HFpEF.
The analysis will be focused on the relation between echocardiographic parameters, especially those concerning right ventricular function and pulmonary hemodynamics, thereby comparing the responses observed in HFrEF vs HFpEF.
Furthermore, correlations between the above-mentioned echocardiographic parameters and parameters of daily clinical practice will be assessed.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: EchocardiocolorDoppler EchocardiocolorDoppler examination |
Drug: Dobutamine
Dobutamine 5.0 - 10.0 mcg/Kg/min ev
Other: Passive leg raising
Passive leg raising for acute volume load
|
Outcome Measures
Primary Outcome Measures
- Right ventricle (RV) volume - Dobutamine [Baseline and at 5 minutes after Dobutamine infusion]
Change in RV volume
- Ejection fraction - Dobutamine [Baseline and at 5 minutes after Dobutamine infusion]
Change in ejection fraction
- Right ventricle (RV) volume - Passive leg raining [Baseline and at 1 minute after passive leg raising for acute volume load]
Change in RV volume
- Ejection fraction - Passive leg raining [Baseline and at 1 minute after passive leg raising for acute volume load]
Change in ejection fraction
Eligibility Criteria
Criteria
Inclusion Criteria:
-
heart failure with reduced (EF ≤40%) or preserved (EF > 50%) ejection fraction
-
echocardiographic acoustic window adequate for evaluation of outcome parameters
-
presence of tricuspid insufficiency which allows assessment of pulmonary artery systolic pressure
Exclusion Criteria:
-
recent myocardial infraction (<3 months) or unstable angina
-
moderate o severe aortic or mitralic valve disease
-
inadequate acoustic window
-
significant anemia (hemoglobin <10 g/dl)
-
recent heart surgery (< 3 months).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ospedale San Luca IRCCS Istituto Auxologico Italiano | Milan | MI | Italy | 20149 |
Sponsors and Collaborators
- Istituto Auxologico Italiano
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 09C923