Heart FailureRISE-HFNCT05797584
Right Ventricular Contractile Reserve in HF
A study testing Dobutamine and Passive leg raising in people with Heart Failure, run by Istituto Auxologico Italiano at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Heart Failure
- What is being tested?
- Dobutamine and Passive leg raising
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 20 Mar 2019to 20 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Ospedale San Luca IRCCS Istituto Auxologico Italiano
Milan, MI, 20149
Sergio Caravita, MD, PhD, +390261911 ext. 2930, s.caravita@auxologico.it
About this study
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)
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.
Read more
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.
- Conditions
- Heart Failure
- Being tested
- Dobutamine, Passive leg raising
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DobutamineDrug
Dobutamine 5.0 - 10.0 mcg/Kg/min ev
Passive leg raisingOther
Passive leg raising for acute volume load
| Study group | Role | What they receive |
|---|---|---|
| EchocardiocolorDoppler | Other | EchocardiocolorDoppler examination Receives: Drug: Dobutamine; Other: Passive leg raising |
What is being measured
The primary outcome is the main question the study is designed to answer.
Right ventricle (RV) volume - Dobutamine
Change in RV volume
Measured: Baseline and at 5 minutes after Dobutamine infusion
Ejection fraction - Dobutamine
Change in ejection fraction
Measured: Baseline and at 5 minutes after Dobutamine infusion
Right ventricle (RV) volume - Passive leg raining
Change in RV volume
Measured: Baseline and at 1 minute after passive leg raising for acute volume load
Ejection fraction - Passive leg raining
Change in ejection fraction
Measured: Baseline and at 1 minute after passive leg raising for acute volume load
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2023
- Study start20 Mar 2019
- Primary completion20 Mar 2025 (estimated)
- Study completion20 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05797584
- Sponsor's protocol ID
- 09C923
- Acronym
- RISE-HF
- Status last verified
- Mar 2023
- First submitted
- 18 Mar 2023
- Last updated
- 4 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05797584
- Acronym / sponsor ID
- RISE-HF / 09C923
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Study start
- 20 Mar 2019 (actual)
- Primary completion
- 20 Mar 2025 (estimated)
- Study completion
- 20 Mar 2026 (estimated)
- First posted
- 4 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EchocardiocolorDoppler | Other | Drug: Dobutamine, Other: Passive leg raisingEchocardiocolorDoppler examination |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DobutamineDobutamine 5.0 - 10.0 mcg/Kg/min ev | Drug | EchocardiocolorDoppler |
| Passive leg raisingPassive leg raising for acute volume load | Other | EchocardiocolorDoppler |
Primary outcome
Right ventricle (RV) volume - Dobutamine
Time frame: Baseline and at 5 minutes after Dobutamine infusion
Change in RV volume
Ejection fraction - Dobutamine
Time frame: Baseline and at 5 minutes after Dobutamine infusion
Change in ejection fraction
Right ventricle (RV) volume - Passive leg raining
Time frame: Baseline and at 1 minute after passive leg raising for acute volume load
Change in RV volume
Ejection fraction - Passive leg raining
Time frame: Baseline and at 1 minute after passive leg raising for acute volume load
Change in ejection fraction
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2023.
Related trials for Heart Failure
RecruitingPhase 3
Maridebart Cafraglutide in Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Obesity
Heart Failure With Preserved Ejection Fraction, Heart Failure With Mildly Reduced Ejection Fraction
Recruiting
Evaluation of the Effects of Sauna Therapy on Congestion and Loop Diuretic Use in Patients With Heart Failure With Reduced or Moderately Reduced Ejection Fraction
Heart Failure
Recruiting
PrEcision Pacing in HFpEF: the PEP-HFpEF Trial
Heart Failure and Preserved Ejection Fraction, Heart Failure New York Heart Association Class III
Enrolling by invitation
EXCOR Active Driving System for the EXCOR Pediatric VAD IDE Study
Heart Failure, Transplant; Failure, Heart
Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dobutamine and Passive leg raising in people with Heart Failure, run by Istituto Auxologico Italiano at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sergio Caravita, MD, PhD (+390261911 ext. 2930, s.caravita@auxologico.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Right ventricle (RV) volume - Dobutamine (time frame: Baseline and at 5 minutes after Dobutamine infusion). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2023.