Volume OverloadEASE-TAVRNCT04556123
Management of Fluid Overload in TAVR
A study testing Measurement of the hydration state and decongestive treatment according to bioimpedance spectroscopy and Measurement of the hydration state and decongestive treatment according to clinical judgement alone in people with Volume Overload, run by Medical University of Vienna at 2 sites in Austria.
Trial summary
Fluid overload (FO) puts aortic stenosis (AS) patients at risk for heart failure and death. However, conventional FO assessment, including rapid weight gain, peripheral edema, or chest radiography, is inaccurate. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Volume Overload
- What is being tested?
- Measurement of the hydration state and decongestive treatment according to bioimpedance spectroscopy and Measurement of the hydration state and decongestive treatment according to clinical judgement alone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 232 participants
- Where
- 2 sitesAustria
- Study dates
- 13 Sep 2020to 1 Apr 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent
- Age ≥18 years
- Scheduled TAVR for the treatment of severe aortic stenosis
- Fluid overlaod ≥7% and/or ≥1L by BIS prior to TAVR (necessary to undergo randomization process)
Who cannot join
- Unwillingness or inability to participate
- Pregnancy
- Chronic dialysis
- Severe electrolyte disorders
Trial locations and contacts
2 sites in 1 country.
Austria2 sites
Karl Landsteiner University
Sankt Pölten, Lower Austria, 3100
Medical University of Vienna
Vienna, 1090
About this study
Official title: Bioimpedance Guided Management of Patients Scheduled for Transcatheter Aortic Valve Replacement: A Randomized Controlled Trial.
Fluid overload (FO) puts aortic stenosis (AS) patients at risk for heart failure and death. However, conventional FO assessment, including rapid weight gain, peripheral edema, or chest radiography, is inaccurate. Bioelectrical impedance spectroscopy (BIS) allows objective and reproducible FO quantification, particularly if clinically unapparent. FO as detected with BIS has recently been linked to worse clinical outcomes of AS patients undergoing transcatheter aortic valve replacement (TAVR).
It is the aim of the present randomised trial to evaluate the potential clinical benefit of pursuing an individualized decongestion treatment strategy in consecutive TAVR patients using BIS.
Read the detailed description
This study is a randomized controlled trial investigating the effect of BIS-guided decongestive treatment on clinical outcomes in overhydrated patients scheduled for and receiving TAVR.
Centers participating in this trial are: Medical University of Vienna, Kepler University Hospital Linz
Consecutive adult patients with severe degenerative AS scheduled for TAVR will be prospectively enrolled at university-affiliated tertiary centers in Austria. Eligibility and decision for TAVR will be determined by a multidisciplinary Heart Team. All patients who are willing to participate will undergo assessment of volume status using BIS prior to intervention. Overhydrated subjects, defined as a relative fluid overload ≥7% (Rel. FO = fluid overload/extracellular water × 100%) and/or absolute fluid overload ≥1L as assessed by BIS, will then be randomly assigned to undergo BIS-guided pre- and postprocedural decongestion treatment vs. decongestion treatment based on mere clinical judgement of volume status in a 1:1 fashion. In order to avoid detection bias, FO patients in the non-BIS group as well as their treating physicians shall be blinded for BIS-results. Physicians and study participants will only be informed about the targeted dry body weight, if randomized to the BIS-guided decongestion group. Decongestion will be performed using standard medication (e.g. loop diuretics) and applied orally or intravenously, as appropriate. After TAVR, patients with FO will be followed before discharge from the hospital, after 3, 6 and 12 months.
Methods:
Patients will undergo standardized evaluation of their fluid status using a portable whole-body BIS device, the Body Composition Monitor (BCM, Fresenius Medical Care, Bad Homburg, Germany). Patients will be placed in supine position before the evaluation of their fluid status. Electrodes will be attached to the nondominant hand and the ipsilateral foot. Measurements will be conducted according to the manufacturer's manual. For each patient, only one bioelectrical impedance analysis will be performed, as this method has an adequate reproducibility. Fluid overload assessed by BCM is expressed as an absolute value in liters or as a relative value in %, calculated as the ratio between fluid overload (FO) and the content of extracellular water (ECW) and multiplied by 100 (Rel. FO = FO/ECW × 100%).
Prespecified study visits:
V0 (14+-13 days prior to TAVR): BIS measurement, pitting edema quantification, demographic factors, symptom assessment, cardiovascular risk factors, ECG, laboratory analysis (e.g. NT-pro BNP, hs-TnT), frailty assessment, KCCQ questionnaire, transthoracic echocardiography; V1 (90+-7 days post TAVR): BIS measurement, pitting edema quantification, demographic factors, symptom assessment, ECG, laboratory analysis (e.g. NT-pro BNP, hs-TnT), KCCQ questionnaire, transthoracic echocardiography; TV2 (telephone visit, 180+-7 days post TAVR): demographic factors, symptom assessment; V3 (360+-7 days post TAVR, =end of treatment): BIS measurement, pitting edema quantification, demographic factors, symptom assessment, ECG, laboratory analysis (e.g. NT-pro BNP, hs-TnT), KCCQ questionnaire, transthoracic echocardiography;
Outcome:
Cardiac outcomes (see below) will be assessed at 3 months (=prespecified interim analysis), and 12 months follwing TAVR.
- Conditions
- Volume Overload
- Being tested
- Measurement of the hydration state and decongestive treatment according to bioimpedance spectroscopy, Measurement of the hydration state and decongestive treatment according to clinical judgement alone
- Keywords
- fluid overload, TAVR, decongestion, bioimpedance spectroscopy
- Medical subject headings
- Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of the hydration state and decongestive treatment according to bioimpedance spectroscopyOther
The measurements will be performed in each center by a reference physician or nurse, using a portable whole body bioimpedance spectroscopy device, BCM (Fresenius Medical Care).
The electrodes will be attached to one hand and one foot on the ipsilateral side, after the patient has been in the supine position for at least 5 minutes.
Measurement of the hydration state and decongestive treatment according to clinical judgement aloneOther
Clinical judgement will be performed in each center by a reference physician or nurse
| Study group | Role | What they receive |
|---|---|---|
| Fluid overload: BIS-guided decongestion | Experimental | Not described Receives: Other: Measurement of the hydration state and decongestive treatment according to bioimpedance spectroscopy |
| Fluid overload: Decongestion based on clinical judgement | Active comparator | Not described Receives: Other: Measurement of the hydration state and decongestive treatment according to clinical judgement alone |
| No fluid overload: standard of care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospitalization for heart failure and/or all-cause death
Measured: 3 and 12 months following TAVR
Secondary outcomes (1)
Change from baseline to 12 months in KCCQ scores
Measured: 3 and 12 months following TAVR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2020
- Study start13 Sep 2020
- Primary completion1 Apr 2023
- Study completion1 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Volume OverloadStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Consecutive patients scheduled for TAVR fulfilling inclusion criteria will be enrolled. Patients with FO will be randomized in a 1:1 fashion to either BIS-guided decongestion or decongestion as per clinical judgement alone. Patients without FO will serve as an euvolemic control cohort.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 232 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christian Nitsche, Medical University of Vienna
- Investigators
- Christian Nitsche, MD, Principal investigator, Medical University of Vienna, Dpt. of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04556123
- Sponsor's protocol ID
- 2074/2019
- Acronym
- EASE-TAVR
- Status last verified
- Jul 2023
- First submitted
- 8 Sep 2020
- Last updated
- 11 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hong YA, Yoon HE, Choi BS, Shin SJ, Kim YS, Lee SY, Lee SH, Kim SH, Lee EY, Shin SK, Kwon YJ, Kim JH, Chang YK, Kim SY, Kim JE, Ahn SY, Ko GJ. The Effect of Strict Volume Control Assessed by Repeated Bioimpedance Spectroscopy on Cardiac Function in Peritoneal Dialysis Patients. Sci Rep. 2019 Nov 27;9(1):17679. doi: 10.1038/s41598-019-53792-0.
PubMed 31776362Machek P, Jirka T, Moissl U, Chamney P, Wabel P. Guided optimization of fluid status in haemodialysis patients. Nephrol Dial Transplant. 2010 Feb;25(2):538-44. doi: 10.1093/ndt/gfp487. Epub 2009 Sep 30.
PubMed 19793930Hur E, Usta M, Toz H, Asci G, Wabel P, Kahvecioglu S, Kayikcioglu M, Demirci MS, Ozkahya M, Duman S, Ok E. Effect of fluid management guided by bioimpedance spectroscopy on cardiovascular parameters in hemodialysis patients: a randomized controlled trial. Am J Kidney Dis. 2013 Jun;61(6):957-65. doi: 10.1053/j.ajkd.2012.12.017. Epub 2013 Feb 15.
PubMed 23415416Koell B, Zotter-Tufaro C, Duca F, Kammerlander AA, Aschauer S, Dalos D, Antlanger M, Hecking M, Saemann M, Mascherbauer J, Bonderman D. Fluid status and outcome in patients with heart failure and preserved ejection fraction. Int J Cardiol. 2017 Mar 1;230:476-481. doi: 10.1016/j.ijcard.2016.12.080. Epub 2016 Dec 21.
PubMed 28062131Stevenson LW, Perloff JK. The limited reliability of physical signs for estimating hemodynamics in chronic heart failure. JAMA. 1989 Feb 10;261(6):884-8.
PubMed 2913385Mulasi U, Kuchnia AJ, Cole AJ, Earthman CP. Bioimpedance at the bedside: current applications, limitations, and opportunities. Nutr Clin Pract. 2015 Apr;30(2):180-93. doi: 10.1177/0884533614568155. Epub 2015 Jan 22.
PubMed 25613832Nitsche C, Kammerlander AA, Koschutnik M, Sinnhuber L, Forutan N, Eidenberger A, Dona C, Schartmueller F, Dannenberg V, Winter MP, Siller-Matula J, Anvari-Pirsch A, Goliasch G, Hengstenberg C, Mascherbauer J. Fluid overload in patients undergoing TAVR: what we can learn from the nephrologists. ESC Heart Fail. 2021 Apr;8(2):1408-1416. doi: 10.1002/ehf2.13226. Epub 2021 Feb 13.
PubMed 33580746Nitsche C, Kammerlander AA, Koschutnik M, Dona C, Aschauer S, Sinnhuber L, Eidenberger A, Forutan N, Schartmueller F, Andreas M, Beitzke D, Bergler-Klein J, Bartko PE, Siller-Matula J, Winter MP, Anvari-Pirsch A, Goliasch G, Hengstenberg C, Mascherbauer J. Volume Status Impacts CMR-Extracellular Volume Measurements and Outcome in AS Undergoing TAVR. JACC Cardiovasc Imaging. 2021 Feb;14(2):516-518. doi: 10.1016/j.jcmg.2020.08.010. Epub 2020 Sep 30. No abstract available.
PubMed 33011120Halavina K, Koschutnik M, Dona C, Autherith M, Petric F, Rockel A, Spinka G, Danesh D, Puchinger J, Wiesholzer M, Mascherbauer K, Heitzinger G, Dannenberg V, Koschatko S, Jantsch C, Winter MP, Goliasch G, Kammerlander AA, Bartko PE, Hengstenberg C, Mascherbauer J, Nitsche C. Management of Fluid Overload in Patients With Severe Aortic Stenosis (EASE-TAVR): A Randomized Controlled Trial. JACC Cardiovasc Interv. 2024 Sep 9;17(17):2054-2066. doi: 10.1016/j.jcin.2024.06.022.
PubMed 39260962
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioimpedance Guided Management of Patients Scheduled for Transcatheter Aortic Valve Replacement: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT04556123
- Acronym / sponsor ID
- EASE-TAVR / 2074/2019
- Conditions
- Volume Overload
- Keywords
- fluid overload, TAVR, decongestion, bioimpedance spectroscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 232 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 13 Sep 2020 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 1 Apr 2023 (actual)
- First posted
- 21 Sep 2020 (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.
Fluid overload (FO) puts aortic stenosis (AS) patients at risk for heart failure and death. However, conventional FO assessment, including rapid weight gain, peripheral edema, or chest radiography, is inaccurate. Bioelectrical impedance spectroscopy (BIS) allows objective and reproducible FO quantification, particularly if clinically unapparent. FO as detected with BIS has recently been linked to worse clinical outcomes of AS patients undergoing transcatheter aortic valve replacement (TAVR).
It is the aim of the present randomised trial to evaluate the potential clinical benefit of pursuing an individualized decongestion treatment strategy in consecutive TAVR patients using BIS.
Detailed description
This study is a randomized controlled trial investigating the effect of BIS-guided decongestive treatment on clinical outcomes in overhydrated patients scheduled for and receiving TAVR.
Centers participating in this trial are: Medical University of Vienna, Kepler University Hospital Linz
Consecutive adult patients with severe degenerative AS scheduled for TAVR will be prospectively enrolled at university-affiliated tertiary centers in Austria. Eligibility and decision for TAVR will be determined by a multidisciplinary Heart Team. All patients who are willing to participate will undergo assessment of volume status using BIS prior to intervention. Overhydrated subjects, defined as a relative fluid overload ≥7% (Rel. FO = fluid overload/extracellular water × 100%) and/or absolute fluid overload ≥1L as assessed by BIS, will then be randomly assigned to undergo BIS-guided pre- and postprocedural decongestion treatment vs. decongestion treatment based on mere clinical judgement of volume status in a 1:1 fashion. In order to avoid detection bias, FO patients in the non-BIS group as well as their treating physicians shall be blinded for BIS-results. Physicians and study participants will only be informed about the targeted dry body weight, if randomized to the BIS-guided decongestion group. Decongestion will be performed using standard medication (e.g. loop diuretics) and applied orally or intravenously, as appropriate. After TAVR, patients with FO will be followed before discharge from the hospital, after 3, 6 and 12 months.
Methods:
Patients will undergo standardized evaluation of their fluid status using a portable whole-body BIS device, the Body Composition Monitor (BCM, Fresenius Medical Care, Bad Homburg, Germany). Patients will be placed in supine position before the evaluation of their fluid status. Electrodes will be attached to the nondominant hand and the ipsilateral foot. Measurements will be conducted according to the manufacturer's manual. For each patient, only one bioelectrical impedance analysis will be performed, as this method has an adequate reproducibility. Fluid overload assessed by BCM is expressed as an absolute value in liters or as a relative value in %, calculated as the ratio between fluid overload (FO) and the content of extracellular water (ECW) and multiplied by 100 (Rel. FO = FO/ECW × 100%).
Prespecified study visits:
V0 (14+-13 days prior to TAVR): BIS measurement, pitting edema quantification, demographic factors, symptom assessment, cardiovascular risk factors, ECG, laboratory analysis (e.g. NT-pro BNP, hs-TnT), frailty assessment, KCCQ questionnaire, transthoracic echocardiography; V1 (90+-7 days post TAVR): BIS measurement, pitting edema quantification, demographic factors, symptom assessment, ECG, laboratory analysis (e.g. NT-pro BNP, hs-TnT), KCCQ questionnaire, transthoracic echocardiography; TV2 (telephone visit, 180+-7 days post TAVR): demographic factors, symptom assessment; V3 (360+-7 days post TAVR, =end of treatment): BIS measurement, pitting edema quantification, demographic factors, symptom assessment, ECG, laboratory analysis (e.g. NT-pro BNP, hs-TnT), KCCQ questionnaire, transthoracic echocardiography;
Outcome:
Cardiac outcomes (see below) will be assessed at 3 months (=prespecified interim analysis), and 12 months follwing TAVR.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Consecutive patients scheduled for TAVR fulfilling inclusion criteria will be enrolled. Patients with FO will be randomized in a 1:1 fashion to either BIS-guided decongestion or decongestion as per clinical judgement alone. Patients without FO will serve as an euvolemic control cohort.
| Arm | Type | Receives |
|---|---|---|
| Fluid overload: BIS-guided decongestion | Experimental | Other: Measurement of the hydration state and decongestive treatment according to bioimpedance spectroscopy |
| Fluid overload: Decongestion based on clinical judgement | Active comparator | Other: Measurement of the hydration state and decongestive treatment according to clinical judgement alone |
| No fluid overload: standard of care | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Written informed consent
- Age ≥18 years
- Scheduled TAVR for the treatment of severe aortic stenosis
- Fluid overlaod ≥7% and/or ≥1L by BIS prior to TAVR (necessary to undergo randomization process)
Key exclusion criteria (4 listed)
- Unwillingness or inability to participate
- Pregnancy
- Chronic dialysis
- Severe electrolyte disorders
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 |
|---|---|---|
| Measurement of the hydration state and decongestive treatment according to bioimpedance spectroscopyThe measurements will be performed in each center by a reference physician or nurse, using a portable whole body bioimpedance spectroscopy device, BCM (Fresenius Medical Care). The electrodes will be attached to one hand and one foot on the ipsilateral side, after the patient has been in the supine position for at least 5 minutes. | Other | Fluid overload: BIS-guided decongestion |
| Measurement of the hydration state and decongestive treatment according to clinical judgement aloneClinical judgement will be performed in each center by a reference physician or nurse | Other | Fluid overload: Decongestion based on clinical judgement |
Primary outcome
Hospitalization for heart failure and/or all-cause death
Time frame: 3 and 12 months following TAVR
1 secondary outcome
Change from baseline to 12 months in KCCQ scores
Time frame: 3 and 12 months following TAVR
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2023.
- Background: PubMed 31776362Hong YA, Yoon HE, Choi BS, Shin SJ, Kim YS, Lee SY, Lee SH, Kim SH, Lee EY, Shin SK, Kwon YJ, Kim JH, Chang YK, Kim SY, Kim JE, Ahn SY, Ko GJ. The Effect of Strict Volume Control Assessed by Repeated Bioimpedance Spectroscopy on Cardiac Function in Peritoneal Dialysis Patients. Sci Rep. 2019 Nov 27;9(1):17679. doi: 10.1038/s41598-019-53792-0.
- Background: PubMed 19793930Machek P, Jirka T, Moissl U, Chamney P, Wabel P. Guided optimization of fluid status in haemodialysis patients. Nephrol Dial Transplant. 2010 Feb;25(2):538-44. doi: 10.1093/ndt/gfp487. Epub 2009 Sep 30.
- Background: PubMed 23415416Hur E, Usta M, Toz H, Asci G, Wabel P, Kahvecioglu S, Kayikcioglu M, Demirci MS, Ozkahya M, Duman S, Ok E. Effect of fluid management guided by bioimpedance spectroscopy on cardiovascular parameters in hemodialysis patients: a randomized controlled trial. Am J Kidney Dis. 2013 Jun;61(6):957-65. doi: 10.1053/j.ajkd.2012.12.017. Epub 2013 Feb 15.
- Background: PubMed 28062131Koell B, Zotter-Tufaro C, Duca F, Kammerlander AA, Aschauer S, Dalos D, Antlanger M, Hecking M, Saemann M, Mascherbauer J, Bonderman D. Fluid status and outcome in patients with heart failure and preserved ejection fraction. Int J Cardiol. 2017 Mar 1;230:476-481. doi: 10.1016/j.ijcard.2016.12.080. Epub 2016 Dec 21.
- Background: PubMed 2913385Stevenson LW, Perloff JK. The limited reliability of physical signs for estimating hemodynamics in chronic heart failure. JAMA. 1989 Feb 10;261(6):884-8.
- Background: PubMed 25613832Mulasi U, Kuchnia AJ, Cole AJ, Earthman CP. Bioimpedance at the bedside: current applications, limitations, and opportunities. Nutr Clin Pract. 2015 Apr;30(2):180-93. doi: 10.1177/0884533614568155. Epub 2015 Jan 22.
- Background: PubMed 33580746Nitsche C, Kammerlander AA, Koschutnik M, Sinnhuber L, Forutan N, Eidenberger A, Dona C, Schartmueller F, Dannenberg V, Winter MP, Siller-Matula J, Anvari-Pirsch A, Goliasch G, Hengstenberg C, Mascherbauer J. Fluid overload in patients undergoing TAVR: what we can learn from the nephrologists. ESC Heart Fail. 2021 Apr;8(2):1408-1416. doi: 10.1002/ehf2.13226. Epub 2021 Feb 13.
- Background: PubMed 33011120Nitsche C, Kammerlander AA, Koschutnik M, Dona C, Aschauer S, Sinnhuber L, Eidenberger A, Forutan N, Schartmueller F, Andreas M, Beitzke D, Bergler-Klein J, Bartko PE, Siller-Matula J, Winter MP, Anvari-Pirsch A, Goliasch G, Hengstenberg C, Mascherbauer J. Volume Status Impacts CMR-Extracellular Volume Measurements and Outcome in AS Undergoing TAVR. JACC Cardiovasc Imaging. 2021 Feb;14(2):516-518. doi: 10.1016/j.jcmg.2020.08.010. Epub 2020 Sep 30. No abstract available.
- Derived from this study: PubMed 39260962Halavina K, Koschutnik M, Dona C, Autherith M, Petric F, Rockel A, Spinka G, Danesh D, Puchinger J, Wiesholzer M, Mascherbauer K, Heitzinger G, Dannenberg V, Koschatko S, Jantsch C, Winter MP, Goliasch G, Kammerlander AA, Bartko PE, Hengstenberg C, Mascherbauer J, Nitsche C. Management of Fluid Overload in Patients With Severe Aortic Stenosis (EASE-TAVR): A Randomized Controlled Trial. JACC Cardiovasc Interv. 2024 Sep 9;17(17):2054-2066. doi: 10.1016/j.jcin.2024.06.022.
- Individual participant dataSharing planned: No
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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.
Christian Nitsche, MD principal investigator
Medical University of Vienna, Dpt. of Cardiology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Measurement of the hydration state and decongestive treatment according to bioimpedance spectroscopy and Measurement of the hydration state and decongestive treatment according to clinical judgement alone in people with Volume Overload, run by Medical University of Vienna at 2 sites in Austria.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 11 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Austria. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospitalization for heart failure and/or all-cause death (time frame: 3 and 12 months following TAVR). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04556123, which also lists 9 linked publications.
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 11 Jul 2023.