Pulmonary HypertensionNCT03039959
Predictive Value of Renal Venous Flow Profiles for Adverse Outcomes in Right Heart Failure
An observational study of Pulmonary Hypertension and Cardiorenal Syndrome, run by University of Giessen at 1 site in Germany.
Trial summary
Predictive value of renal venous flow profiles for adverse outcomes in patients with right heart failure Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Hypertension, Cardiorenal Syndrome, Heart Failure
- How many people
- 421 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2016to 30 Sep 2019
- How long will I take part?
- 18 Months
- Phase
- Observational
- 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
Study population: Consecutive Pulmonology inpatients with suspected or pre-diagnosed pulmonary hypertension undergoing right heart catheterization (pulmonary hypertension cohort) and consecutive Cardiology inpatients who are referred to the consultant nephrologist with a history of diuretic-resistant fluid overload and impaired renal function (heart failure cohort).
Who may be able to join
None listed.
Who cannot join
- CKD stage 5 (KDIGO)
- pre-existing acute kidney injury (acute kidney injury was defined as an increase in serum creatinine by ≥ 0.3 mg/dl within 48 hours or to ≥ 1.5 times baseline within the prior 7 days, as determined by all available serum creatinine values from hospital and outpatient medical records within the previous 90 days)
- Non-end stage renal disease patients with extracorporeal or peritoneal ultrafiltration for treatment of diuretic-resistant fluid overload
- Patients with primary kidney disease (e.g., glomerulonephritis, autosomal dominant polycystic kidney disease, postrenal obstruction)
- solid-organ transplant recipients
- use of non-steroidal inflammatory drugs within 72 hours before right heart catheterization
Show all 9Show fewer
- Heart failure cohort:
- Exclusion criteria same as in the discovery cohort except pre-existing acute kidney injury
- Patients with mechanical assist devices are excluded
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Clinic Giessen and Marburg - Campus Giessen
Giessen, Hesse, 35392
About this study
Predictive value of renal venous flow profiles for adverse outcomes in patients with right heart failure
Read the detailed description
Persistent congestion with deteriorating renal function is an important cause of adverse outcomes in heart failure. The investigators aimed to characterize new Doppler ultrasonography approaches to evaluate the continuum of renal congestion. Pulmonary hypertension is the most common precursor to right heart failure and thus represents an ideal scenario to study congestion. The second cohort comprises consecutive Cardiology inpatients aged ≥18 years with a new or pre-existing diagnosis of heart failure who are referred to the consultant nephrologist with a history of diuretic-resistant fluid overload and impaired renal function. The investigators choose patients with heart failure to broaden the findings to the most common clinical entity of right ventricular failure.
- Conditions
- Pulmonary Hypertension, Cardiorenal Syndrome, Heart Failure
- Being tested
- No intervention
- Keywords
- Renal Doppler ultrasonography, Venous Congestion
- Medical subject headings
- Hypertension, Pulmonary, Cardio-Renal Syndrome, Heart Failure, Hyperemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionDiagnostic test
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary hypertension cohort | Consecutive adult Pulmonology inpatients with suspected or pre-diagnosed pulmonary hypertension undergoing invasive right heart catheterization. Receives: Diagnostic Test: No intervention | |
| Heart failure cohort | Consecutive adult Cardiology inpatients with a new or pre-existing diagnosis of heart failure who are referred to the consultant nephrologist with a history of diuretic-resistant fluid overload and impaired renal function. Receives: Diagnostic Test: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of pulmonary hypertension-related morbidity and all-cause mortality (pulmonary hypertension cohort)
Any hospitalization for worsening of pulmonary hypertension, lung transplantation, or need for escalation of pulmonary hypertension-specific therapy, and death from any cause
Measured: 1 year post-discharge
First occurrence of worsening heart failure and first occurrence of need for renal replacement therapy (heart failure cohort)
Unscheduled hospitalization or unscheduled office visit for heart failure and new onset renal replacement therapy
Measured: 1 year post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2017 (estimated)
- Study startNov 2016
- Primary completion30 Mar 2018
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 421 participants (actual)
- Target duration
- 18 Months
Sponsor and investigators
- Lead sponsor
- University of Giessen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Faeq Husain, University of Giessen
- Investigators
- Werner Seeger, MD, Study director, Department of Internal Medicine II; Division of Pulmonology, Nephrology and Critical Care Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03039959
- Sponsor's protocol ID
- AZ 237/16
- Status last verified
- Feb 2020
- First submitted
- 29 Jan 2017
- Last updated
- 18 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Navaneethan SD, Wehbe E, Heresi GA, Gaur V, Minai OA, Arrigain S, Nally JV Jr, Schold JD, Rahman M, Dweik RA. Presence and outcomes of kidney disease in patients with pulmonary hypertension. Clin J Am Soc Nephrol. 2014 May;9(5):855-63. doi: 10.2215/CJN.10191013. Epub 2014 Feb 27.
PubMed 24578332Iida N, Seo Y, Sai S, Machino-Ohtsuka T, Yamamoto M, Ishizu T, Kawakami Y, Aonuma K. Clinical Implications of Intrarenal Hemodynamic Evaluation by Doppler Ultrasonography in Heart Failure. JACC Heart Fail. 2016 Aug;4(8):674-82. doi: 10.1016/j.jchf.2016.03.016. Epub 2016 May 11.
PubMed 27179835Sugiura T, Wada A. Resistive index predicts renal prognosis in chronic kidney disease. Nephrol Dial Transplant. 2009 Sep;24(9):2780-5. doi: 10.1093/ndt/gfp121. Epub 2009 Mar 23.
PubMed 19318356Kuhnert S, Sommerlad J, Gall H, Weder MM, Wolff M, Eberle S, Sander M, Reichert M, Koch C, Askevold I, Hecker A, Padberg W, Ostermann M, Mehta R, Ronco C, Birk HW, Seeger W, Mayer K, Hecker M, Husain-Syed F. Postoperative Fluid Accumulation is Associated With Underestimation of AKI Severity in Lung Transplant Recipients. Clin Transplant. 2024 Sep;38(9):e15457. doi: 10.1111/ctr.15457.
PubMed 39282762Husain-Syed F, Singam NSV, Viehman JK, Vaughan L, Bauer P, Gall H, Tello K, Richter MJ, Yogeswaran A, Romero-Gonzalez G, Rosner MH, Ronco C, Assmus B, Ghofrani HA, Seeger W, Birk HW, Kashani KB. Changes in Doppler-Derived Kidney Venous Flow and Adverse Cardiorenal Outcomes in Patients With Heart Failure. J Am Heart Assoc. 2023 Aug 15;12(16):e030145. doi: 10.1161/JAHA.123.030145. Epub 2023 Aug 14.
PubMed 37577933Husain-Syed F, Birk HW, Ronco C, Schormann T, Tello K, Richter MJ, Wilhelm J, Sommer N, Steyerberg E, Bauer P, Walmrath HD, Seeger W, McCullough PA, Gall H, Ghofrani HA. Doppler-Derived Renal Venous Stasis Index in the Prognosis of Right Heart Failure. J Am Heart Assoc. 2019 Nov 5;8(21):e013584. doi: 10.1161/JAHA.119.013584. Epub 2019 Oct 19.
PubMed 31630601
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of Renal Venous Flow Profiles for Adverse Outcomes in Right Heart Failure
- ClinicalTrials.gov ID
- NCT03039959
- Acronym / sponsor ID
- AZ 237/16
- Conditions
- Pulmonary Hypertension, Cardiorenal Syndrome, Heart Failure
- Keywords
- Renal Doppler ultrasonography, Venous Congestion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 421 participants (actual)
- Lead sponsor
- University of GiessenUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- 30 Mar 2018 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 1 Feb 2017 (estimated)
- 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.
Predictive value of renal venous flow profiles for adverse outcomes in patients with right heart failure
Detailed description
Persistent congestion with deteriorating renal function is an important cause of adverse outcomes in heart failure. The investigators aimed to characterize new Doppler ultrasonography approaches to evaluate the continuum of renal congestion. Pulmonary hypertension is the most common precursor to right heart failure and thus represents an ideal scenario to study congestion. The second cohort comprises consecutive Cardiology inpatients aged ≥18 years with a new or pre-existing diagnosis of heart failure who are referred to the consultant nephrologist with a history of diuretic-resistant fluid overload and impaired renal function. The investigators choose patients with heart failure to broaden the findings to the most common clinical entity of right ventricular failure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 18 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulmonary hypertension cohort | – | Diagnostic Test: No interventionConsecutive adult Pulmonology inpatients with suspected or pre-diagnosed pulmonary hypertension undergoing invasive right heart catheterization. |
| Heart failure cohort | – | Diagnostic Test: No interventionConsecutive adult Cardiology inpatients with a new or pre-existing diagnosis of heart failure who are referred to the consultant nephrologist with a history of diuretic-resistant fluid overload and impaired renal function. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive Pulmonology inpatients with suspected or pre-diagnosed pulmonary hypertension undergoing right heart catheterization (pulmonary hypertension cohort) and consecutive Cardiology inpatients who are referred to the consultant nephrologist with a history of diuretic-resistant fluid overload and impaired renal function (heart failure cohort).
Key inclusion criteria (0 listed)
Key exclusion criteria (9 listed)
- CKD stage 5 (KDIGO)
- pre-existing acute kidney injury (acute kidney injury was defined as an increase in serum creatinine by ≥ 0.3 mg/dl within 48 hours or to ≥ 1.5 times baseline within the prior 7 days, as determined by all available serum creatinine values from hospital and outpatient medical records within the previous 90 days)
- Non-end stage renal disease patients with extracorporeal or peritoneal ultrafiltration for treatment of diuretic-resistant fluid overload
- Patients with primary kidney disease (e.g., glomerulonephritis, autosomal dominant polycystic kidney disease, postrenal obstruction)
- solid-organ transplant recipients
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 |
|---|---|---|
| No interventionNo intervention | Diagnostic test | Heart failure cohort, Pulmonary hypertension cohort |
Primary outcome
Rate of pulmonary hypertension-related morbidity and all-cause mortality (pulmonary hypertension cohort)
Time frame: 1 year post-discharge
Any hospitalization for worsening of pulmonary hypertension, lung transplantation, or need for escalation of pulmonary hypertension-specific therapy, and death from any cause
First occurrence of worsening heart failure and first occurrence of need for renal replacement therapy (heart failure cohort)
Time frame: 1 year post-discharge
Unscheduled hospitalization or unscheduled office visit for heart failure and new onset renal replacement therapy
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 18 Feb 2020.
- Results publication: PubMed 24578332Navaneethan SD, Wehbe E, Heresi GA, Gaur V, Minai OA, Arrigain S, Nally JV Jr, Schold JD, Rahman M, Dweik RA. Presence and outcomes of kidney disease in patients with pulmonary hypertension. Clin J Am Soc Nephrol. 2014 May;9(5):855-63. doi: 10.2215/CJN.10191013. Epub 2014 Feb 27.
- Results publication: PubMed 27179835Iida N, Seo Y, Sai S, Machino-Ohtsuka T, Yamamoto M, Ishizu T, Kawakami Y, Aonuma K. Clinical Implications of Intrarenal Hemodynamic Evaluation by Doppler Ultrasonography in Heart Failure. JACC Heart Fail. 2016 Aug;4(8):674-82. doi: 10.1016/j.jchf.2016.03.016. Epub 2016 May 11.
- Results publication: PubMed 19318356Sugiura T, Wada A. Resistive index predicts renal prognosis in chronic kidney disease. Nephrol Dial Transplant. 2009 Sep;24(9):2780-5. doi: 10.1093/ndt/gfp121. Epub 2009 Mar 23.
- Derived from this study: PubMed 39282762Kuhnert S, Sommerlad J, Gall H, Weder MM, Wolff M, Eberle S, Sander M, Reichert M, Koch C, Askevold I, Hecker A, Padberg W, Ostermann M, Mehta R, Ronco C, Birk HW, Seeger W, Mayer K, Hecker M, Husain-Syed F. Postoperative Fluid Accumulation is Associated With Underestimation of AKI Severity in Lung Transplant Recipients. Clin Transplant. 2024 Sep;38(9):e15457. doi: 10.1111/ctr.15457.
- Derived from this study: PubMed 37577933Husain-Syed F, Singam NSV, Viehman JK, Vaughan L, Bauer P, Gall H, Tello K, Richter MJ, Yogeswaran A, Romero-Gonzalez G, Rosner MH, Ronco C, Assmus B, Ghofrani HA, Seeger W, Birk HW, Kashani KB. Changes in Doppler-Derived Kidney Venous Flow and Adverse Cardiorenal Outcomes in Patients With Heart Failure. J Am Heart Assoc. 2023 Aug 15;12(16):e030145. doi: 10.1161/JAHA.123.030145. Epub 2023 Aug 14.
- Derived from this study: PubMed 31630601Husain-Syed F, Birk HW, Ronco C, Schormann T, Tello K, Richter MJ, Wilhelm J, Sommer N, Steyerberg E, Bauer P, Walmrath HD, Seeger W, McCullough PA, Gall H, Ghofrani HA. Doppler-Derived Renal Venous Stasis Index in the Prognosis of Right Heart Failure. J Am Heart Assoc. 2019 Nov 5;8(21):e013584. doi: 10.1161/JAHA.119.013584. Epub 2019 Oct 19.
- Individual participant dataSharing planned: Undecided
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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.
Werner Seeger, MD study director
Department of Internal Medicine II; Division of Pulmonology, Nephrology and Critical Care Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Hypertension and Cardiorenal Syndrome, run by University of Giessen at 1 site in Germany.
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 0 inclusion and 9 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 18 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
Rate of pulmonary hypertension-related morbidity and all-cause mortality (pulmonary hypertension cohort) (time frame: 1 year post-discharge). The study lists 2 primary outcomes in all. 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 NCT03039959, which also lists 6 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 18 Feb 2020.