Heart FailureNATRIUM-HFNCT04235062
NATriuretic Response to Expansion and dIUretics in huMans With Heart Failure
A study testing Ringer's (8.6 g/L sodium chloride, 0.33 g/L calcium chloride, 0.3 g/L potassium chloride) Solution and Intravenous Bolus Furosemide in people with Heart Failure, run by Momentum Research, Inc. at 13 sites in 3 countries.
Trial summary
NATRIUM-HF is a multicenter, non-randomized, pre-post intervention study designed to assess renal response to intravascular fluid expansion and diuretics after sacubitril/valsartan (Entresto®) in euvolemic heart failure patients with reduced ejection fraction. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Ringer's (8.6 g/L sodium chloride, 0.33 g/L calcium chloride, 0.3 g/L potassium chloride) Solution and Intravenous Bolus Furosemide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 229 participants
- Where
- 13 sitesin 3 countries
- Study dates
- 1 Apr 2020to 26 Apr 2021
- 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 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients ≥ 18 and < 80 years of age.
- Ambulatory patients with a diagnosis of stable NYHA class II heart failure with left ventricular ejection fraction <40 %, for whom sacubitril/valsartan (Entresto®) is indicated as recommended by ESC guidelines and are about to be switched to Entresto® therapy.
- Stable oral doses of ACEi or ARB, beta-blocker, mineralocorticoid antagonist (MRA), and loop diuretic (up to 120 mg daily furosemide or equivalent*) for > 3 months prior to Screening, except where intolerance or contraindication documented.
- Stable HF without any recent exacerbation of symptoms and/or signs of HF, admission for HF, unplanned clinic visit or emergency service visit for HF or need for significant up titration or new administration of oral or IV diuretics, renin-angiotensin system (RAAS) blockers (including ACEi, ARB, and/or MRA) and/or beta blockers for > 3 months.
- Euvolemia as defined by no signs of congestion (pulmonary rales or >1+ peripheral edema) by physical examination.
- Written informed consent to participate in the study.
- Ability to comply with all study requirements, without major morbidities compromising the patient's ability to participate and understand the study for 90 days.
Who cannot join
- Significant pulmonary disease contributing substantially to the patients' dyspnea such as FEV1< 1 liter or need for chronic steroid therapy.
- Myocardial infarction, unstable angina, ICD or CRT implantation, or cardiac surgery, including percutaneous transluminal coronary intervention, within past 3 months.
- History of heart transplant or on a transplant list, or using or planned to be implanted with a ventricular assist device.
- Sustained ventricular arrhythmia with syncopal episodes within past 3 months that is untreated.
- Presence of any hemodynamically significant valvular stenosis or regurgitation, except mitral or tricuspid regurgitation secondary to left ventricular dilatation. Presence of hemodynamically significant obstructive lesions of left ventricular outflow tract.
- Stroke or TIA within the past 3 months
Show all 24Show fewer
- Primary liver disease considered to be life threatening.
- Any episode of symptomatic hypotension within 3 months prior to screening.
- Known history of angioedema with ACEi or ARB use, or history of hereditary or idiopathic angioedema.
- Coagulation or bleeding disorder.
- Systolic blood pressure < 100 mmHg.
- Serum sodium > 146 mEq/L (146 mmol/L).
- Serum potassium > 5.2 mEq/L (5.2 mmol/L) or < 3.5 mEq/L (3.5 mmol/L).
- Renal disease or eGFR < 30 ml/min/1.73m2 (as measured by the simplified MDRD formula).
- Ultrafiltration or dialysis within 3 months prior to Screening.
- Hypersensitivity to sacubitril, valsartan, or any of the excipients in Entresto®; or hypersensitivity to furosemide.
- History or presence of any other diseases (i.e. including malignancies) with a life expectancy of < 3 months.
- Participation in any CHF trial or any investigational drug or device study within the 30 days prior to Screening.
- History of noncompliance to medical regimens and patients who are considered potentially unreliable.
- Pregnant or nursing (lactating) women.
- Active infection based on abnormal temperature and elevated WBC count.
- Receipt of blood transfusion within 3 months prior to Screening.
- Current use of any drug containing a direct renin inhibitor (aliskiren) or neprilysin inhibitor (sacubitril).
- Equivalent oral loop diuretic doses will be considered as 1 mg bumetanide=20 mg torsemide=80 mg furosemide
Trial locations and contacts
13 sites in 3 countries.
13 sites in 3 countries
Russia7 sites
Regional budget Healthcare Institution "Cardiological dispensary"
Ivanovo
Moscow State Budgetary Institution of Healthcare of Moscow "City Clinical Hospital named after V.V. Vinogradov of the Department of Healthcare of Moscow"
Moscow
State Budgetary Healthcare Institution of Moscow "City clinical hospital #51 of the Department of Healthcare of Moscow"
Moscow
State Budgetary Healthcare Institution of Moscow "City Clinical Hospital named after V.V. Veresaev of the Department of Healthcare of Moscow"
Moscow
State Budgetary Healthcare Institution of Moscow "Moscow City Clinical Hospital named after V.M. Buyanov" of the Department of Healthcare of Moscow"
Moscow
MedFort LLC
Saint Petersburg
State Budgetary Healthcare Institution of Vladimir region "Vladimir City Hospital # 4"
Vladimir
Armenia4 sites
Erebouni Medical Center CJSC
Yerevan
Institute of Cardiology named after L.A. Hovhannisyan
Yerevan
Nairi Medical Center
Yerevan
Yerevan State Medical University
Yerevan
Bosnia and Herzegovina2 sites
University Clinical Center Republic of Srpska, Banja Luka Department of Cardiology
Banja Luka
University Clinical Center Mostar
Mostar
About this study
NATRIUM-HF is a multicenter, non-randomized, pre-post intervention study designed to assess renal response to intravascular fluid expansion and diuretics after sacubitril/valsartan (Entresto®) in euvolemic heart failure patients with reduced ejection fraction. Approximately 230 eligible patients will attend one visit prior to and visits 2 and 3 months after starting Entresto®. At each visit, the patient's responses to extravascular fluid expansion with Ringer's solution and to a loop diuretic bolus will be measured. Biomarkers measured in blood and urine samples will include natriuretic peptides (NP) B-type NP (BNP) and N-terminal proBNP (NT-proBNP), NP fragments, neprilysin activity and concentration, and other biomarkers related to heart failure.
Read the detailed description
NATRIUM-HF is a multicenter, non-randomized, pre-post intervention study designed to assess renal response to intravascular fluid expansion and diuretics after sacubitril/valsartan (Entresto®) in euvolemic heart failure patients with reduced ejection fraction.
Ambulatory patients with HFrEF who remain symptomatic despite optimal treatment for more than 3 months with an ACEi or ARB, a beta-blocker and a mineralocorticoid receptor antagonist (MRA) for whom sacubitril/valsartan is indicated and is about to be initiated will be enrolled. Approximately 230 patients will attend three outpatient visits: before, and 2 months and 3 months after initiation of, or switch from treatment with angiotensin-converting-enzyme inhibitor (ACEi) or angiotensin II receptor blocker (ARB) to, oral treatment with the angiotensin receptor-neprilysin inhibitor (ARNi) sacubitril/valsartan (Entresto®). Patient's responses to fluid expansion and diuretic administration will be assessed at each study visit.
The same procedures will be followed at each visit. First, baseline vital signs, clinical assessments (dyspnea score, jugular vein distension, peripheral edema score, pulmonary rales), and blood samples will be obtained. Urine will be collected over a period of 3 hours and urine samples will be obtained from the collected urine at the end of the 3-hour collection period, and vital signs and clinical assessments will be obtained.
This will be followed by an infusion of 0.5 liter Ringer's (8.6 g/L sodium chloride, 0.33 g/L calcium chloride, 0.3 g/L potassium chloride) solution infused in 10 min followed by an infusion of 0.5 liter over 1 hour 50 minutes. Of note 1liter Ringer's contains 8.6 g or 374 mmol of sodium. 1 hour after the end of the infusion, clinical assessments (dyspnea score, jugular vein distension, peripheral edema score, pulmonary rales) and blood samples will be obtained. Urine will be collected over a period of 3 hours and urine samples will be obtained from the collected urine at the end of the 3-hour collection period.
After the second set of blood and urine samples are obtained, 40 mg of furosemide will be given IV and blood samples will be obtained thereafter hourly for 3 hours. Urine will be collected over a period of 3 hours and urine samples will be obtained from the collected urine at the end of the 3-hour collection period, and vital signs and clinical assessments will be obtained.
Biomarkers measured in blood and urine samples will include natriuretic peptides (NP) B-type NP (BNP) and N-terminal proBNP (NT-proBNP), NP fragments, neprilysin activity and concentration, and other biomarkers related to heart failure.
The aim of NATRIUM-HF is to assess the change in natriuretic response to intravascular fluid expansion and diuretics in euvolemic patients with heart failure and reduced ejection fraction (HFrEF) after initiation of, or switch from ACEi/ARB to, sacubitril/valsartan (Entresto®) therapy.
- Conditions
- Heart Failure
- Being tested
- Ringer's (8.6 g/L sodium chloride, 0.33 g/L calcium chloride, 0.3 g/L potassium chloride) Solution, Intravenous Bolus Furosemide
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ringer's (8.6 g/L sodium chloride, 0.33 g/L calcium chloride, 0.3 g/L potassium chloride) SolutionDrug
Also called Intravascular fluid expansion
A 2-hour of infusion of Ringer's (8.6 g/L sodium chloride, 0.33 g/L calcium chloride, 0.3 g/L potassium chloride) solution will be given following completion of the first 3-hour urine collection period: 0.5 liter infused over 10 min followed by 0.5 liter infused over 1 hour 50 minutes.
Intravenous Bolus FurosemideDrug
Also called Loop diuretic administration
Following completion of the second 3-hour urine collection period and after the second set of blood and urine samples are obtained, 40 mg of furosemide will be given as an IV bolus.
| Study group | Role | What they receive |
|---|---|---|
| Fluid Expansion and Diuretic Challenge | Experimental | Subject receive intravenous infusion of Ringer's (8.6 g/L sodium chloride, 0.33 g/L calcium chloride, 0.3 g/L potassium chloride) solution, followed by diuretic challenge with 40mg Furosemide intravenous bolus. Receives: Drug: Ringer's (8.6 g/L sodium chloride, 0.33 g/L calcium chloride, 0.3 g/L potassium chloride) Solution; Drug: Intravenous Bolus Furosemide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Natriuretic response to intravascular volume expansion
The average change in natriuretic response to intravascular volume expansion from before to 2 and 3 months after initiation of sacubitril/valsartan therapy. Natriuretic response is defined as the cumulative sodium excretion over the 3 hours of intravascular volume expansion and follow up.
Measured: 2 and 3 months
Natriuretic response to IV diuretic administration
The average change in cumulative natriuresis during the first 3 h following the bolus IV furosemide administration from before to 2 and 3 months after initiation of sacubitril/valsartan therapy.
Measured: 2 and 3 months
Secondary outcomes (4)
Natriuretic peptide (NP) response to intravascular volume expansion
Change from from before to 2 and 3 months after initiation of sacubitril/valsartan therapy in the average change over the 2-hour Ringer's infusion and follow up in plasma NP levels from just prior to the start of the infusion.
Measured: 2 and 3 months
Natriuretic peptide response to IV diuretic administration
Change from before to 2 and 3 months after initiation of sacubitril/valsartan therapy in the average change in NP level from the end of the Ringer's infusion to 3 hours following the bolus IV furosemide administration
Measured: 2 and 3 months
Diuretic response
Change from before to 2 and 3 months after initiation of sacubitril/valsartan therapy in the urine volume excreted over the 3 hours following the bolus IV furosemide administration
Measured: 2 and 3 months
4. Changes in dyspnea as measured by a 1-10 scale in response to intravascular fluid expansion, and diuretic administration
Change from before to 2 and 3 months after initiation of sacubitril/valsartan therapy in the average change from just prior to the Ringer's infusion start to one hour following the 2-hour Ringer's infusion and from just prior to the IV bolus furosemide administration to 3 hours following the bolus IV furosemide administration
Measured: 2 and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2020
- Study start1 Apr 2020
- Primary completion26 Apr 2021
- Study completion26 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 229 participants (actual)
Sponsor and investigators
- Lead sponsor
- Momentum Research, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Saint-Louis-Lariboisière University Hospitals, Abbott
- Responsible party
- Sponsor
- Investigators
- Alexandre Mebazaa, MD PhD FESC, Principal investigator, Hôpitaux Universitaires Saint-Louis-Lariboisière
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04235062
- Sponsor's protocol ID
- CHF201901
- Acronym
- NATRIUM-HF
- Status last verified
- Apr 2022
- First submitted
- 15 Jan 2020
- Last updated
- 18 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
McMurray JJ, Packer M, Desai AS, Gong J, Lefkowitz MP, Rizkala AR, Rouleau JL, Shi VC, Solomon SD, Swedberg K, Zile MR; PARADIGM-HF Investigators and Committees. Angiotensin-neprilysin inhibition versus enalapril in heart failure. N Engl J Med. 2014 Sep 11;371(11):993-1004. doi: 10.1056/NEJMoa1409077. Epub 2014 Aug 30.
PubMed 25176015Nijst P, Verbrugge FH, Martens P, Dupont M, Tang WHW, Mullens W. Renal response to intravascular volume expansion in euvolemic heart failure patients with reduced ejection fraction: Mechanistic insights and clinical implications. Int J Cardiol. 2017 Sep 15;243:318-325. doi: 10.1016/j.ijcard.2017.05.041. Epub 2017 May 14.
PubMed 28545850Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JG, Coats AJ, Falk V, Gonzalez-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GM, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P; Authors/Task Force Members; Document Reviewers. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC). Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur J Heart Fail. 2016 Aug;18(8):891-975. doi: 10.1002/ejhf.592. Epub 2016 May 20. No abstract available.
PubMed 27207191Tuttolomondo A, Pinto A, Di Raimondo D, Corrao S, Di Sciacca R, Scaglione R, Caruso C, Licata G. Changes in natriuretic peptide and cytokine plasma levels in patients with heart failure, after treatment with high dose of furosemide plus hypertonic saline solution (HSS) and after a saline loading. Nutr Metab Cardiovasc Dis. 2011 May;21(5):372-9. doi: 10.1016/j.numecd.2009.10.014. Epub 2010 Mar 25.
PubMed 20346637
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NATriuretic Response to Expansion and dIUretics in huMans With Heart Failure
- ClinicalTrials.gov ID
- NCT04235062
- Acronym / sponsor ID
- NATRIUM-HF / CHF201901
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 229 participants (actual)
- Lead sponsor
- Momentum Research, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Saint-Louis-Lariboisière University Hospitals, Abbott
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 26 Apr 2021 (actual)
- Study completion
- 26 Apr 2021 (actual)
- First posted
- 21 Jan 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.
NATRIUM-HF is a multicenter, non-randomized, pre-post intervention study designed to assess renal response to intravascular fluid expansion and diuretics after sacubitril/valsartan (Entresto®) in euvolemic heart failure patients with reduced ejection fraction. Approximately 230 eligible patients will attend one visit prior to and visits 2 and 3 months after starting Entresto®. At each visit, the patient's responses to extravascular fluid expansion with Ringer's solution and to a loop diuretic bolus will be measured. Biomarkers measured in blood and urine samples will include natriuretic peptides (NP) B-type NP (BNP) and N-terminal proBNP (NT-proBNP), NP fragments, neprilysin activity and concentration, and other biomarkers related to heart failure.
Detailed description
NATRIUM-HF is a multicenter, non-randomized, pre-post intervention study designed to assess renal response to intravascular fluid expansion and diuretics after sacubitril/valsartan (Entresto®) in euvolemic heart failure patients with reduced ejection fraction.
Ambulatory patients with HFrEF who remain symptomatic despite optimal treatment for more than 3 months with an ACEi or ARB, a beta-blocker and a mineralocorticoid receptor antagonist (MRA) for whom sacubitril/valsartan is indicated and is about to be initiated will be enrolled. Approximately 230 patients will attend three outpatient visits: before, and 2 months and 3 months after initiation of, or switch from treatment with angiotensin-converting-enzyme inhibitor (ACEi) or angiotensin II receptor blocker (ARB) to, oral treatment with the angiotensin receptor-neprilysin inhibitor (ARNi) sacubitril/valsartan (Entresto®). Patient's responses to fluid expansion and diuretic administration will be assessed at each study visit.
The same procedures will be followed at each visit. First, baseline vital signs, clinical assessments (dyspnea score, jugular vein distension, peripheral edema score, pulmonary rales), and blood samples will be obtained. Urine will be collected over a period of 3 hours and urine samples will be obtained from the collected urine at the end of the 3-hour collection period, and vital signs and clinical assessments will be obtained.
This will be followed by an infusion of 0.5 liter Ringer's (8.6 g/L sodium chloride, 0.33 g/L calcium chloride, 0.3 g/L potassium chloride) solution infused in 10 min followed by an infusion of 0.5 liter over 1 hour 50 minutes. Of note 1liter Ringer's contains 8.6 g or 374 mmol of sodium. 1 hour after the end of the infusion, clinical assessments (dyspnea score, jugular vein distension, peripheral edema score, pulmonary rales) and blood samples will be obtained. Urine will be collected over a period of 3 hours and urine samples will be obtained from the collected urine at the end of the 3-hour collection period.
After the second set of blood and urine samples are obtained, 40 mg of furosemide will be given IV and blood samples will be obtained thereafter hourly for 3 hours. Urine will be collected over a period of 3 hours and urine samples will be obtained from the collected urine at the end of the 3-hour collection period, and vital signs and clinical assessments will be obtained.
Biomarkers measured in blood and urine samples will include natriuretic peptides (NP) B-type NP (BNP) and N-terminal proBNP (NT-proBNP), NP fragments, neprilysin activity and concentration, and other biomarkers related to heart failure.
The aim of NATRIUM-HF is to assess the change in natriuretic response to intravascular fluid expansion and diuretics in euvolemic patients with heart failure and reduced ejection fraction (HFrEF) after initiation of, or switch from ACEi/ARB to, sacubitril/valsartan (Entresto®) therapy.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fluid Expansion and Diuretic Challenge | Experimental | Drug: Ringer's (8.6 g/L sodium chloride, 0.33 g/L calcium chloride, 0.3 g/L potassium chloride) Solution, Drug: Intravenous Bolus FurosemideSubject receive intravenous infusion of Ringer's (8.6 g/L sodium chloride, 0.33 g/L calcium chloride, 0.3 g/L potassium chloride) solution, followed by diuretic challenge with 40mg Furosemide intravenous bolus. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female patients ≥ 18 and < 80 years of age.
- Ambulatory patients with a diagnosis of stable NYHA class II heart failure with left ventricular ejection fraction <40 %, for whom sacubitril/valsartan (Entresto®) is indicated as recommended by ESC guidelines and are about to be switched to Entresto® therapy.
- Stable oral doses of ACEi or ARB, beta-blocker, mineralocorticoid antagonist (MRA), and loop diuretic (up to 120 mg daily furosemide or equivalent*) for > 3 months prior to Screening, except where intolerance or contraindication documented.
- Stable HF without any recent exacerbation of symptoms and/or signs of HF, admission for HF, unplanned clinic visit or emergency service visit for HF or need for significant up titration or new administration of oral or IV diuretics, renin-angiotensin system (RAAS) blockers (including ACEi, ARB, and/or MRA) and/or beta blockers for > 3 months.
- Euvolemia as defined by no signs of congestion (pulmonary rales or >1+ peripheral edema) by physical examination.
Key exclusion criteria (24 listed)
- Significant pulmonary disease contributing substantially to the patients' dyspnea such as FEV1< 1 liter or need for chronic steroid therapy.
- Myocardial infarction, unstable angina, ICD or CRT implantation, or cardiac surgery, including percutaneous transluminal coronary intervention, within past 3 months.
- History of heart transplant or on a transplant list, or using or planned to be implanted with a ventricular assist device.
- Sustained ventricular arrhythmia with syncopal episodes within past 3 months that is untreated.
- Presence of any hemodynamically significant valvular stenosis or regurgitation, except mitral or tricuspid regurgitation secondary to left ventricular dilatation. Presence of hemodynamically significant obstructive lesions of left ventricular outflow tract.
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 |
|---|---|---|
| Ringer's (8.6 g/L sodium chloride, 0.33 g/L calcium chloride, 0.3 g/L potassium chloride) SolutionAlso: Intravascular fluid expansionA 2-hour of infusion of Ringer's (8.6 g/L sodium chloride, 0.33 g/L calcium chloride, 0.3 g/L potassium chloride) solution will be given following completion of the first 3-hour urine collection period: 0.5 liter infused over 10 min followed by 0.5 liter infused over 1 hour 50 minutes. | Drug | Fluid Expansion and Diuretic Challenge |
| Intravenous Bolus FurosemideAlso: Loop diuretic administrationFollowing completion of the second 3-hour urine collection period and after the second set of blood and urine samples are obtained, 40 mg of furosemide will be given as an IV bolus. | Drug | Fluid Expansion and Diuretic Challenge |
Primary outcome
Natriuretic response to intravascular volume expansion
Time frame: 2 and 3 months
The average change in natriuretic response to intravascular volume expansion from before to 2 and 3 months after initiation of sacubitril/valsartan therapy. Natriuretic response is defined as the cumulative sodium excretion over the 3 hours of intravascular volume expansion and follow up.
Natriuretic response to IV diuretic administration
Time frame: 2 and 3 months
The average change in cumulative natriuresis during the first 3 h following the bolus IV furosemide administration from before to 2 and 3 months after initiation of sacubitril/valsartan therapy.
4 secondary outcomes
Natriuretic peptide (NP) response to intravascular volume expansion
Time frame: 2 and 3 months
Natriuretic peptide response to IV diuretic administration
Time frame: 2 and 3 months
Diuretic response
Time frame: 2 and 3 months
4. Changes in dyspnea as measured by a 1-10 scale in response to intravascular fluid expansion, and diuretic administration
Time frame: 2 and 3 months
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 Apr 2022.
- Background: PubMed 25176015McMurray JJ, Packer M, Desai AS, Gong J, Lefkowitz MP, Rizkala AR, Rouleau JL, Shi VC, Solomon SD, Swedberg K, Zile MR; PARADIGM-HF Investigators and Committees. Angiotensin-neprilysin inhibition versus enalapril in heart failure. N Engl J Med. 2014 Sep 11;371(11):993-1004. doi: 10.1056/NEJMoa1409077. Epub 2014 Aug 30.
- Background: PubMed 28545850Nijst P, Verbrugge FH, Martens P, Dupont M, Tang WHW, Mullens W. Renal response to intravascular volume expansion in euvolemic heart failure patients with reduced ejection fraction: Mechanistic insights and clinical implications. Int J Cardiol. 2017 Sep 15;243:318-325. doi: 10.1016/j.ijcard.2017.05.041. Epub 2017 May 14.
- Background: PubMed 27207191Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JG, Coats AJ, Falk V, Gonzalez-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GM, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P; Authors/Task Force Members; Document Reviewers. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC). Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur J Heart Fail. 2016 Aug;18(8):891-975. doi: 10.1002/ejhf.592. Epub 2016 May 20. No abstract available.
- Background: PubMed 20346637Tuttolomondo A, Pinto A, Di Raimondo D, Corrao S, Di Sciacca R, Scaglione R, Caruso C, Licata G. Changes in natriuretic peptide and cytokine plasma levels in patients with heart failure, after treatment with high dose of furosemide plus hypertonic saline solution (HSS) and after a saline loading. Nutr Metab Cardiovasc Dis. 2011 May;21(5):372-9. doi: 10.1016/j.numecd.2009.10.014. Epub 2010 Mar 25.
- 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.
Alexandre Mebazaa, MD PhD FESC principal investigator
Hôpitaux Universitaires Saint-Louis-Lariboisière
13 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ringer's (8.6 g/L sodium chloride, 0.33 g/L calcium chloride, 0.3 g/L potassium chloride) Solution and Intravenous Bolus Furosemide in people with Heart Failure, run by Momentum Research, Inc. at 13 sites in 3 countries.
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 7 inclusion and 24 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 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Russia, Armenia, Bosnia and Herzegovina. 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?
Natriuretic response to intravascular volume expansion (time frame: 2 and 3 months). 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 NCT04235062, which also lists 4 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 Apr 2022.