Ignite Creation Date:
2024-07-17 @ 10:54 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06495892
Status:
RECRUITING
Last Update Posted:
2024-07-11
First Post:
2024-06-25
Brief Title:
PVP-Guided Decongestive Therapy in HF 2
Sponsor:
Başakşehir Çam Sakura City Hospital
Organization:
Başakşehir Çam Sakura City Hospital
Study Overview
Official Title:
Peripheral Venous Pressure-Guided Decongestive Therapy in Heart Failure 2
Status:
RECRUITING
Status Verified Date:
2024-08
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:
PERIPHERAL-HF2
Brief Summary:
The investigators hypothesize that a simple assessment of peripheral venous pressure PVP will better predict the diuretic need and long-term outcomes all cause mortality all cause rehospitalization emergency department visits compared to standard evaluation
Detailed Description:
I BACKGROUND AND SIGNIFICANCE
Precise assessment of volume status is essential in diagnosis and management of diuretic therapy in patients hospitalized for heart failure HF Unfortunately no clear guidelines are present for in-hospital management of congestion Consequently nearly half of the patients hospitalized for congestive HF are discharged with persistent congestion This contributes to high rates of readmission and mortality
Recently it has been shown that a simple assessment of peripheral venous pressure PVP demonstrates a high correlation with central venous pressure CVP indicating that PVP may be useful in the standard bedside clinical assessment of volume status in HF patients to help guiding decongestive therapy
II THE HYPOTHESIS
The main hypothesis is as follows A simple assessment of peripheral venous pressure PVP will better guide the diuretic need and long-term outcomes all-cause mortality all cause re-hospitalization emergency department visits compared to standard evaluation
III METHODS
1 Application for Institutional Review Board IRBEthics board approval The study will be at participating centers An IRBEthics board approval has been obtained from Marmara University Pendik Training and Research Hospital local ethics board
2 Study population Patients 18-99 years old who were admitted with a de novo or decompensated chronic HF and accept to participate in the study will be enrolled Patients will be included regardless of ejection fraction or etiology of HF but these will be noted as baseline variables All patients or legal surrogate decision makers will be requested to provide a written informed consent prior to enrollment Patients who withdraw their consent those with upper extremity venous pathology those with a baseline creatinine level equal to or above 35 mgdL those with severe stenotic valvular disease and hypertrophic cardiomyopathy will be excluded
3 Data Collection The study will start at participating centers on July 1 2024
Baseline variables Baseline variables will be entered to the electronic study form RedCap
Procedures A peripheral intravenous IV access using an 18 to 22-gauge IV line will be placed preferably to an upper extremity vein before enrollment This line will be used to draw blood samples first After blood samples were collected the subjects will be randomized to standard or PVP guided therapy groups Randomization will be done using a computer-generated random allocation list via RedCap randomization module The details of demographic characteristics symptoms physical examination findings and drug list will be noted to a standard electronic study form see appendix A routine electrocardiogram and echocardiogram will be performed at the earliest convenience
After the blood samples were collected line will be flushed carefully PVP will be obtained by transducing a peripheral intravenous line after zeroing at the phlebostatic axis The phlebostatic axis will be accepted as the midpoint between the anterior and posterior surfaces of the chest at the level of the fourth intercostal space meets with sternum which is assumed to be correlated with the mid-level of the right atrium The patients arm will be placed parallel to the patient such that the position of the peripheral IV to be at the phlebostatic axis Continuity of the peripheral IV line with the central venous system will be confirmed by demonstrating augmentation of the venous pressure waveform using manual or tourniquet circumferential occlusion of the extremity proximal to the catheter and modified Valsalva maneuver If the pressure waveform failed to augment appropriately data will not be collected and the patient will be documented for study purposes as a technique failure Daily fluid intake and output weight and biochemistry measurements as required will be done
The patients in whom the first and the predischarge PVP cannot be measured due to technical issues unable to provide upper extremity IV access unable to confirm augmentation or Valsalva test will be excluded from the study Also the patients requiring in-hospital intubation high-dose inotrope or vasopressor infusion 10 mcgkg-1min-1 dopamine dobutamine or equivalent intraaortic balloon support dialysis or veno-venous ultrafiltration will be excluded from the study but these patients will be included in the in-hospital analyses
In hospital diuretic treatment will be guided by ESC guidelines see references In the standard therapy arm the treatment and the decision of discharge will be left to physicians discretion In the PVP-guided arm a PVP 9 mmHg will be targeted before discharge
Outcomes The primary outcome of the study is the composite endpoint of all-cause mortality all-cause hospitalization and all-cause emergency department visits The secondary outcomes will include cardiovascular mortality HF-related hospitalization HF-related emergency department visits This information on these outcomes will be obtained from the national electronic database The follow-up duration is planned to be limited to one year
Predefined secondary analyses
There will be subanalyses from the same cohort as defined below
The correlation between predischarge PVP and long-term outcomes A multivariable analysis will also be executed for predicting the primary end point
The correlation between the change in PVP during hospital stay and long-term outcomes A multivariable analysis will also be executed for predicting the primary end point
The correlation between the change in PVP during hospital stay and worsening renal function renal injury need for dialysis or veno-venous ultrafiltration
The comparison of the two arms in terms of worsening renal function need for dialysis or veno-venous ultrafiltration
The comparison of the two arms in terms of EVEREST congestion score
The comparison of the two arms in terms of the days in hospital
The comparison of the two arms in terms of the number of repeat hospitalizations
Usual patterns of diuretic use
Estimated number of subjects to be submitted
We estimated that the enrollment of 586 participants would provide the study with a statistical power of 95 to detect a relative excess rate of 10 in primary outcome peripheral pressure guided group 20 versus standard approach 30 with the use of a two-sided test at the 005 level With an estimation of 10 follow-up loss we aim to enroll at least 650 patients in a one-year enrollment period
Statistical Analysis Baseline characteristics will be summarized using standard descriptive statistics Comparisons of relevant parameters between groups will be performed by chi-square Fishers exact test Mann-Whitney U Kruskal-Wallis H test one-way ANOVA and student t-test as appropriate Patients with missing values will be excluded pairwise from analyses Kaplan-Meier analysis will be performed to determine the cumulative long-term mortality and composite outcome rates in subgroups The mortality across groups will be compared using log-rank test A Cox-regression model will be used to perform a survival analysis according to pre-discharge peripheral venous pressure and composite outcome Baseline characteristics with a P value of 005 or less in the univariate analysis will be included and a step-down procedure will be applied for selection of final covariates Statistical analyses will be performed with SPSS version 240 SPSS Inc Chicago IL and MedCalc Software version 1821 Evaluation version MedCalc Software Ostend Belgium
Precise assessment of volume status is essential in diagnosis and management of diuretic therapy in patients hospitalized for heart failure HF Unfortunately no clear guidelines are present for in-hospital management of congestion Consequently nearly half of the patients hospitalized for congestive HF are discharged with persistent congestion This contributes to high rates of readmission and mortality
Recently it has been shown that a simple assessment of peripheral venous pressure PVP demonstrates a high correlation with central venous pressure CVP indicating that PVP may be useful in the standard bedside clinical assessment of volume status in HF patients to help guiding decongestive therapy
II THE HYPOTHESIS
The main hypothesis is as follows A simple assessment of peripheral venous pressure PVP will better guide the diuretic need and long-term outcomes all-cause mortality all cause re-hospitalization emergency department visits compared to standard evaluation
III METHODS
1 Application for Institutional Review Board IRBEthics board approval The study will be at participating centers An IRBEthics board approval has been obtained from Marmara University Pendik Training and Research Hospital local ethics board
2 Study population Patients 18-99 years old who were admitted with a de novo or decompensated chronic HF and accept to participate in the study will be enrolled Patients will be included regardless of ejection fraction or etiology of HF but these will be noted as baseline variables All patients or legal surrogate decision makers will be requested to provide a written informed consent prior to enrollment Patients who withdraw their consent those with upper extremity venous pathology those with a baseline creatinine level equal to or above 35 mgdL those with severe stenotic valvular disease and hypertrophic cardiomyopathy will be excluded
3 Data Collection The study will start at participating centers on July 1 2024
Baseline variables Baseline variables will be entered to the electronic study form RedCap
Procedures A peripheral intravenous IV access using an 18 to 22-gauge IV line will be placed preferably to an upper extremity vein before enrollment This line will be used to draw blood samples first After blood samples were collected the subjects will be randomized to standard or PVP guided therapy groups Randomization will be done using a computer-generated random allocation list via RedCap randomization module The details of demographic characteristics symptoms physical examination findings and drug list will be noted to a standard electronic study form see appendix A routine electrocardiogram and echocardiogram will be performed at the earliest convenience
After the blood samples were collected line will be flushed carefully PVP will be obtained by transducing a peripheral intravenous line after zeroing at the phlebostatic axis The phlebostatic axis will be accepted as the midpoint between the anterior and posterior surfaces of the chest at the level of the fourth intercostal space meets with sternum which is assumed to be correlated with the mid-level of the right atrium The patients arm will be placed parallel to the patient such that the position of the peripheral IV to be at the phlebostatic axis Continuity of the peripheral IV line with the central venous system will be confirmed by demonstrating augmentation of the venous pressure waveform using manual or tourniquet circumferential occlusion of the extremity proximal to the catheter and modified Valsalva maneuver If the pressure waveform failed to augment appropriately data will not be collected and the patient will be documented for study purposes as a technique failure Daily fluid intake and output weight and biochemistry measurements as required will be done
The patients in whom the first and the predischarge PVP cannot be measured due to technical issues unable to provide upper extremity IV access unable to confirm augmentation or Valsalva test will be excluded from the study Also the patients requiring in-hospital intubation high-dose inotrope or vasopressor infusion 10 mcgkg-1min-1 dopamine dobutamine or equivalent intraaortic balloon support dialysis or veno-venous ultrafiltration will be excluded from the study but these patients will be included in the in-hospital analyses
In hospital diuretic treatment will be guided by ESC guidelines see references In the standard therapy arm the treatment and the decision of discharge will be left to physicians discretion In the PVP-guided arm a PVP 9 mmHg will be targeted before discharge
Outcomes The primary outcome of the study is the composite endpoint of all-cause mortality all-cause hospitalization and all-cause emergency department visits The secondary outcomes will include cardiovascular mortality HF-related hospitalization HF-related emergency department visits This information on these outcomes will be obtained from the national electronic database The follow-up duration is planned to be limited to one year
Predefined secondary analyses
There will be subanalyses from the same cohort as defined below
The correlation between predischarge PVP and long-term outcomes A multivariable analysis will also be executed for predicting the primary end point
The correlation between the change in PVP during hospital stay and long-term outcomes A multivariable analysis will also be executed for predicting the primary end point
The correlation between the change in PVP during hospital stay and worsening renal function renal injury need for dialysis or veno-venous ultrafiltration
The comparison of the two arms in terms of worsening renal function need for dialysis or veno-venous ultrafiltration
The comparison of the two arms in terms of EVEREST congestion score
The comparison of the two arms in terms of the days in hospital
The comparison of the two arms in terms of the number of repeat hospitalizations
Usual patterns of diuretic use
Estimated number of subjects to be submitted
We estimated that the enrollment of 586 participants would provide the study with a statistical power of 95 to detect a relative excess rate of 10 in primary outcome peripheral pressure guided group 20 versus standard approach 30 with the use of a two-sided test at the 005 level With an estimation of 10 follow-up loss we aim to enroll at least 650 patients in a one-year enrollment period
Statistical Analysis Baseline characteristics will be summarized using standard descriptive statistics Comparisons of relevant parameters between groups will be performed by chi-square Fishers exact test Mann-Whitney U Kruskal-Wallis H test one-way ANOVA and student t-test as appropriate Patients with missing values will be excluded pairwise from analyses Kaplan-Meier analysis will be performed to determine the cumulative long-term mortality and composite outcome rates in subgroups The mortality across groups will be compared using log-rank test A Cox-regression model will be used to perform a survival analysis according to pre-discharge peripheral venous pressure and composite outcome Baseline characteristics with a P value of 005 or less in the univariate analysis will be included and a step-down procedure will be applied for selection of final covariates Statistical analyses will be performed with SPSS version 240 SPSS Inc Chicago IL and MedCalc Software version 1821 Evaluation version MedCalc Software Ostend Belgium
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