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Right Ventricular Contractile Reserve in HF (RISE-HF)

Primary Purpose

Heart Failure

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Dobutamine
Passive leg raising
Sponsored by
Istituto Auxologico Italiano
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Heart Failure

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • Ospedale San Luca IRCCS Istituto Auxologico ItalianoRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

EchocardiocolorDoppler

Arm Description

EchocardiocolorDoppler examination

Outcomes

Primary Outcome Measures

Right ventricle (RV) volume - Dobutamine
Change in RV volume
Ejection fraction - Dobutamine
Change in ejection fraction
Right ventricle (RV) volume - Passive leg raining
Change in RV volume
Ejection fraction - Passive leg raining
Change in ejection fraction

Secondary Outcome Measures

Full Information

First Posted
March 18, 2023
Last Updated
March 30, 2023
Sponsor
Istituto Auxologico Italiano
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1. Study Identification

Unique Protocol Identification Number
NCT05797584
Brief Title
Right Ventricular Contractile Reserve in HF
Acronym
RISE-HF
Official Title
Valutazione Ecocardiografica Della Riserva Contrattile Del Ventricolo Destro Dopo Carico Volemico Acuto Mediante Sollevamento Passivo Delle Gambe e Durante Infusione di Dobutamina in Pazienti Affetti da Scompenso Cardiaco a Frazione d'Eiezione Ridotta (HFrEF) e Preservata (HFpEF)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 20, 2019 (Actual)
Primary Completion Date
March 20, 2025 (Anticipated)
Study Completion Date
March 20, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto Auxologico Italiano

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
EchocardiocolorDoppler
Arm Type
Other
Arm Description
EchocardiocolorDoppler examination
Intervention Type
Drug
Intervention Name(s)
Dobutamine
Intervention Description
Dobutamine 5.0 - 10.0 mcg/Kg/min ev
Intervention Type
Other
Intervention Name(s)
Passive leg raising
Intervention Description
Passive leg raising for acute volume load
Primary Outcome Measure Information:
Title
Right ventricle (RV) volume - Dobutamine
Description
Change in RV volume
Time Frame
Baseline and at 5 minutes after Dobutamine infusion
Title
Ejection fraction - Dobutamine
Description
Change in ejection fraction
Time Frame
Baseline and at 5 minutes after Dobutamine infusion
Title
Right ventricle (RV) volume - Passive leg raining
Description
Change in RV volume
Time Frame
Baseline and at 1 minute after passive leg raising for acute volume load
Title
Ejection fraction - Passive leg raining
Description
Change in ejection fraction
Time Frame
Baseline and at 1 minute after passive leg raising for acute volume load

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sergio Caravita, MD, PhD
Phone
+390261911
Ext
2930
Email
s.caravita@auxologico.it
Facility Information:
Facility Name
Ospedale San Luca IRCCS Istituto Auxologico Italiano
City
Milan
State/Province
MI
ZIP/Postal Code
20149
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sergio Caravita, MD, PhD
Phone
+390261911
Ext
2930
Email
s.caravita@auxologico.it

12. IPD Sharing Statement

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Right Ventricular Contractile Reserve in HF

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