Ignite Creation Date:
2024-05-06 @ 7:24 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT06002321
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-08-21
First Post:
2023-07-21
Brief Title:
Right Ventricular Dysfunction in Chronic Heart Failure
Sponsor:
University of Siena
Organization:
University of Siena
Study Overview
Official Title:
Right Ventricular Dysfunction in Chronic Heart Failure Clinical Laboratory and Echocardiographic Characteristics
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RIVED-CHF
Brief Summary:
The goal of this multi center observational prospective study is to analyze the concordance between the signs and symptoms of RHF and echocardiographic features of RVD in patient with heart failure The main questions it aims to answer are
1 to assess the incidence of RVH and RVD in each HF subtypes
2 to evaluate prognostic impact in terms of cardiovascular mortality and HF hospitalization of different RVD patterns during a mean followup period of 3 years
3 To investigate the incidence of different RV maladaptation isolated RV dilatation isolated Pulmonary hypertension combined pattern in each HF groups and the related outcome
Participants will follow by direct check up visit andor virtual visits every 6 months for a mean follow-up period of 3 years
1 to assess the incidence of RVH and RVD in each HF subtypes
2 to evaluate prognostic impact in terms of cardiovascular mortality and HF hospitalization of different RVD patterns during a mean followup period of 3 years
3 To investigate the incidence of different RV maladaptation isolated RV dilatation isolated Pulmonary hypertension combined pattern in each HF groups and the related outcome
Participants will follow by direct check up visit andor virtual visits every 6 months for a mean follow-up period of 3 years
Detailed Description:
Right ventricular dysfunction RVD and pulmonary hypertension PH have been recognized as two important prognostic features in patients with left side heart failure HF Nevertheless literature does not distinguish between right heart failure RHF and RVD and the two terms are indifferently employed to describe PH and impaired RV performance This is a multicenter observational prospective study endorsed by the Italian Society of Cardiology that would analyse the concordance between the signs and symptoms of RHF and echocardiographic features of RVD Therefore the right ventricle RV adaptation across different left ventricular ejection fraction LVEF values is poorly investigated According to the recent heart failure HF guidelines classified patients based on LVEF in HF with preserved HFpEF mild reduced HFmEF and reduced LVEF HFrEF the investigators would assess by seral clinical laboratory and detailed echocardiographic study all patients affected by chronic HF regardless LVEF threshold in stable condition and will follow by direct check up visit andor virtual visits every 6 months for a mean follow-up period of 3 years All clinical laboratory and echocardiographic data will be recorded in a web platform system accessible for all center included in the study The main aims of the study are 1- to assess the incidence of RVH and RVD in each HF subtypes 2- to evaluate prognostic impact in terms of cardiovascular mortality and HF hospitalization of different RVD patterns during a mean followup period of 3 years 3- To investigate the incidence of different RV maladaptation isolated RV dilatation isolated Pulmonary hypertension combined pattern in each HF groups and the related outcome The investigators expect to find different RVD degree and severity according to the type of left HF and its severity Additionally by a serial multiparametric analysis of RV it would be possible to establish the stage and type of RVD and consequent concordance with signs of RHF
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None