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RecruitingNCT05797584RISE-HFUpdated Apr 4, 2023

Right Ventricular Contractile Reserve in HF

An interventional study of Dobutamine and Passive leg raising in Heart Failure, sponsored by Istituto Auxologico Italiano. Recruiting at 1 site in Italy. Per ClinicalTrials.gov, last updated 2023-04-04.

Sponsored by Istituto Auxologico Italiano · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Primary completion was expected by Mar 2025, 1 year 6 months ago, but the record still lists the study as recruiting.
  • Registered 3 years 11 months after the study started (first participant enrolled Mar 2019, registered Mar 2023).
  • Started Mar 2019; still recruiting 7 years 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Sex
All
01

Study 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.

02

Conditions studied

  • Heart Failure

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03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's planned enrollment of 60 is below the median of 72 across 3,736 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Istituto Auxologico Italiano is the lead sponsor of 196 studies on the registry; 78 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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).
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Other
    EchocardiocolorDoppler

    EchocardiocolorDoppler examination

    Drug: Dobutamine · Other: Passive leg raising

Interventions

  • DrugDobutamine

    Dobutamine 5.0 - 10.0 mcg/Kg/min ev

  • OtherPassive leg raising

    Passive leg raising for acute volume load

06

What researchers measure

Primary outcomes

  1. Right ventricle (RV) volume - Dobutamine

    Change in RV volume

    Time frame: Baseline and at 5 minutes after Dobutamine infusion

  2. Ejection fraction - Dobutamine

    Change in ejection fraction

    Time frame: Baseline and at 5 minutes after Dobutamine infusion

  3. Right ventricle (RV) volume - Passive leg raining

    Change in RV volume

    Time frame: Baseline and at 1 minute after passive leg raising for acute volume load

  4. Ejection fraction - Passive leg raining

    Change in ejection fraction

    Time frame: Baseline and at 1 minute after passive leg raising for acute volume load

07

Study locations

1 of 1 sites recruiting
  • Ospedale San Luca IRCCS Istituto Auxologico Italiano
    Milan, MI 20149, Italy
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 4, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05797584
Lead sponsor
Istituto Auxologico Italiano
Responsible party
Sponsor
First posted
Apr 4, 2023
Start date
Mar 20, 2019
Primary completion
Mar 20, 2025 (estimated)
Completion
Mar 20, 2026 (estimated)
Last update
Apr 4, 2023

Study contacts

Sergio Caravita, MD, PhD
Contact
s.caravita@auxologico.it
+390261911 ext. 2930

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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