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NCT05797584: RISE-HF
Right Ventricular Contractile Reserve in HF
NA trial testing Dobutamine in Heart Failure in 60 participants. Status unknown.
20 March 2025
Quick facts
| Lead sponsor | Istituto Auxologico Italiano |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 60 |
| Start date | 20 March 2019 |
| Primary completion | 20 March 2025 |
| Estimated completion | 20 March 2026 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Dobutamine (DOBUTAMINE) — full drug profile →
- Passive leg raising
Conditions studied
- Heart Failure — all drugs for Heart Failure →
Sponsor
Istituto Auxologico Italiano — full company profile →
Who can join
Eligibility, any sex, with Heart Failure. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05797584
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05797584 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Istituto Auxologico Italiano
- Last refreshed: 4 April 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05797584.
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